RB GB 11.web

Instrument
Reprocessing
Reprocessing
of Instruments to Retain Value
Working Group
Instrument Reprocessing 11
Reprocessing of Instruments to Retain Value
11th edition 2017
Surgical Instruments
Microsurgical Instruments
Dental Instruments
Motor Systems
Instruments for Minimally Invasive Surgery, Rigid Endoscopes, Robotic Instruments and HF Instruments
Flexible Endoscopes and Accessories
Flexible Instruments and respiration systems
Previous German-language editions: Current foreign-language editions:

1st edition 1979 Arabic, 10th edition 2017
2nd edition 1983 Chinese 10th anniversary edition 2016
3rd edition 1985 Croatian, 8th revised edition 2006
4th edition 1990 Czech, 10th edition 2012
5th edition 1993 Dutch, 10th edition 2012
6th edition 1997 English, 10th anniversary edition 2016
7th edition 1999 French, 10th edition 2012
8th edition 2004 Greek, 9th edition 2009
8th revised edition 2005 Hungarian, 8th revised edition 2005
9th edition 2009 Indonesian, 8th revised edition 2005
10th edition 2012 Italian, 9th anniversary edition 2016
10th anniversary edition 2016 Japanese, 10th edition 2012
Norwegian, 8th edition 2004
Polish, 10th edition 2012
Portuguese, 9. edition 2009
Romanian, 8th revised edition 2005
Russian, 10th edition 2012
Spanish, 10th anniversary edition 2016
Turkish, 10th anniversary edition 2016
Website:
www.a-k-i.org
These brochures are available to download free of charge in PDF format from our website www.a-k-i.org,
where you can also find our Terms of Sale. You can also order AKI brochures directly at the
e-mail address: [email protected]
All rights reserved Arbeitskreis Instrumenten-Aufbereitung (Instrument Reprocessing Working Group) (c) 2017
Carl-Miele-Straße 29 | D-33332 Gütersloh
No part of this publication may be reproduced in any form.
Reprocessing of Instruments to Retain Value, 11th edition 2017, www.a-k-i.org 3

The working group
INSTRUMENT REPROCESSING
consists of the following members:
Instruments product group: Disinfectant cleaning and Washers, disinfectors and

care agents product group: sterilizers product group:
Wolfgang Fuchs Sebastian Niebur Robert Eibl

c/o Aesculap c/o Ecolab Deutschland c/o MMM
Am Aesculap-Platz Ecolab Allee 1 Semmelweisstraße 6
D-78532 Tuttlingen D-40789 Monheim am Rhein D-82152 Planegg
Tel.: +49 (0)7461-95 27 98 Tel.: +49 (0)2173-599 1733 Tel.: +49 (0)89-89918-334
Dr. Gerhard Kirmse Verona Schmidt Markus Hoppe

c/o Aesculap c/o Chem. Fabrik Dr. Weigert c/o Miele
Am Aesculap-Platz Mühlenhagen 85 Mielestr. 2
D-78532 Tuttlingen D-20539 Hamburg D-33611 Bielefeld
Tel.: +49 (0)7461-95 28 80 Tel.: +49 (0)40-78960-179 Tel.: +49 (0) 521-807-74522
Helmi Henn Dr. Matthias Tschoerner Michael Sedlag

c/o Richard Wolf c/o Chem. Fabrik Dr. Weigert c/o Miele
Pforzheimer Straße 32 Mühlenhagen 85 Carl-Miele-Straße 29
D-75438 Knittlingen D-20539 Hamburg D-33332 Gütersloh
Tel.: +49 (0)7043-35-4144 Tel.: +49 (0)40-78960-401 Tel.: +49 (0)5241-89-1461
Bernd Tangel
c/o Richard Wolf Adviser:
Pforzheimer Straße 32
D-75438 Knittlingen Dr. Holger Biering Prof. Dr. Ulrich Junghannß
Tel.: +49 (0)7043-35-4485 Gladiolenstr. 19 c/o Hochschule Anhalt (FH)
D-41516 Grevenbroich Bernburger Straße 55
D-06366 Köthen
Karl Leibinger Tel.: +49 (0)2182-3159
Tel.: +49 (0)3496-67 2534
c/o KLS Martin Group, Gebr. Martin
Kolbinger Straße 10 Dr. Winfried Michels
D-78570 Mühlheim c/o Prüflabor DWM
Tel.: +49 (0)7463-838-110 Kasseler Tor 20
D-34414 Warburg
Massimo Fiamma Tel.: +49 (0) 5642-6126
c/o KLS Martin Group, Gebr. Martin
KLS Martin Platz 1
D-78532 Tuttlingen
We should like to offer our warm thanks to all former members of AKI who
Tel.: +49 (0)7461-706 347 are not specifically mentioned here by name for developing and
constantly expanding the stock of AKI booklets.
4 Reprocessing of Instruments to Retain Value, 11th edition 2017, www.a-k-i.org

Apart from the permanent
members of the Working
Group, the following
persons contributed as
guests:
Endoscopes and MIS: Surgical motor systems: General guests:
Heidrun Groten-Schweizer Rainer Häusler Dr. Jürgen Wegmann

c/o Pentax Europe c/o Aesculap c/o Aesculap
D- 22527 Hamburg D-78532 Tuttlingen D-78532 Tuttlingen
Klaus Hebestreit Marcus Schäfer Anke Carter

c/o Aesculap c/o Aesculap c/o MMM
D-78532 Tuttlingen D-78532 Tuttlingen D-82152 Planegg
Dr. Birgit Kampf Aaron Papadopoulos

c/o Olympus Europa Ultrasound: c/o Ecolab Germany
D-22045 Hamburg D-40789 Monheim am Rhein
Horst Weiss Stefan Bandelin

c/o Karl Storz c/o Bandelin
D-78532 Tuttlingen D-12207 Berlin
Elastic instruments: Water treatment:
Roland Maichel Dr. Herbert Bendlin

c/o Teleflex Medical GmbH c/o Technisches
Rüsch Care Product Division Sachverständigenbüro
D-71394 Kernen D-56235 Ransbach-Baumbach

Reprocessing of Instruments
to Retain Value
Table of Contents
Authors and Addresses 4
Preface 8
Foreword 10
Introduction 11
1. Materials and Design 14

1.1 Materials 14
1.2 Design 17
2. Media used for instrument reprocessing 18

2.1 Water 18
2.2 Process chemicals 22
2.2.1 Types of process chemicals 23
2.2.2 Properties and assessment of constituent substances 24
3. How to Treat Brand New and Repaired Instruments 27
4. Procedure Recommendations for Returned Goods 28
5. Preparation for Cleaning and Disinfecting 30
6. Manual and Automated Cleaning and Disinfecting 33

6.1 Manual Cleaning and Disinfecting 33
6.2 Automated Cleaning and Disinfecting 37
6.2.1 Automated Cleaning and Thermal Disinfection 38
6.2.2 Automated Cleaning and
Chemo-thermal Disinfection 40
6.2.3 Instrument Groups Requiring Special Treatment 41
6.3 Ultrasonic Cleaning and Disinfecting 44
7. Final Disinfection 47
8. Checks and Care 48
9. Packaging 54

10. Sterilization 55
10.1 Steam Sterilization 56
10.2 Hot-Air Sterilization 58
10.3 Low-Temperature Sterilization 59
11. Storage 60
11.1 Storing Non-Sterile Instruments 60
11.2 Storing Sterile Instruments 61
12. Surface Changes: Deposits, Discoloration,

Corrosion, Aging, Swelling and Stress Cracks 61
12.1 Metal/Deposits – Organic Residues 62
12.2 Metal/Deposits – Process Chemical Residues 63
12.3 Metal/Deposits – Spotting Caused by Lime 64
12.4 Metal/Discoloration – Caused by Titanium Oxide
or Silicates 64
12.5 Metal/Discoloration – Caused by Oxidation 66
12.6 Metal/Discoloration – Caused by Stripping of
Colored Plasma Layers 68
12.7 Metal/Corrosion – Pitting 69
12.8 Metal/Corrosion – Wear Friction Corrosion 70
12.9 Metal/Corrosion – Stress Corrosion Cracking 71
12.10 Metal/Corrosion – Surface Corrosion 73
12.10.1 Stainless Steels 73
12.10.2 Anodized Aluminum 74
12.11 Metal/Corrosion – Contact Corrosion 75
12.12 Metal/Corrosion – Extraneous and Film
Rust/Subsequent Rust 76
12.13 Metal/Corrosion – Crevice Corrosion 77
12.14 Plastic/Rubber – Aging 78
12.15 Plastic/Rubber – Swelling 79
12.16 Plastic – Stress Cracks 80
13. Glossary 82
14. Bibliography 86
15. Schematic Flow Chart as per EN ISO 17664 88
AKI sales conditions 90
Legal Notice and Disclaimer 90

Preface
The Instrument Reprocessing Working Group (AKI) was founded in
1976 with the aim of developing and publishing expertise and practical
information on the safe reprocessing of instruments in healthcare with
the aim of retaining their value. Having been established for four years
as of 2016, AKI has not only become part of the history of "instrument
reprocessing", but also embodies the present, serving as an inspiration
for the future of our specialty field as an example of multidisciplinary and
interactive cooperation.
Efforts to ensure the independence of the departments for sterile supplies

over these past decades, now known as the "Reprocessing Unit for
Medical Products (RUMP)", were an important step towards establishing a
scientific basis and much improved reprocessing. This was later followed
by the industrialization of the department (i.e. viewing the sterile supplies
department as an industrial production unit), assisted by the introduction
of quality management systems and IT systems.
Today, we have reached the next phase, defined by a more unified

perspective of "reprocessing". A sterile medical product is the sum of a
series of actions, of which the sterilization process itself is only a part.
Sterility is the result of integrity across processes, which also requires
"all-inclusive" responsibility to be assumed by the reprocessing
department for this overall process. This responsibility no longer ends
at the exit door of the Reprocessing Unit for Medical Products – today,
it reaches as far as the operating theater, the patient's bed, and the
treatment room of the clinic.
AKI's great achievement lies in always having remained within its

essence. Its various publications have made a significant contribution to
establishing a robust basis for the reprocessing of healthcare instruments,
offering practical solutions to everyday problems faced by sterile supplies
departments or dental practice. For instance, these may be problems
relating to water reprocessing and water quality, to the selection and
dosage of cleaning agents, to the structure of programs of various devices,
to the quality of the instruments themselves, and also to the organization
of work flows, which has a major impact on the quality of the end product
and on its long-term value. These are recurring problems for which even
the latest apps cannot help to find definitive solutions. Ultimately, they
require daily monitoring of the various parameters and timely intervention
in the event of significant discrepancies. They require the ongoing
vigilance of the staff of the Reprocessing Unit for Medical Products.
The influence that AKI's publications have had and continue to have
on modern sterilization is impossible to overestimate. AKI since offers

information through two generations of "sterilization staff", information
that, as previously stated, is only becoming more expansive and has lost
nothing of its relevance to this day. Additionally, the brochures help to
ensure much-needed continuity, especially as the pioneers of sterilization
are beginning to leave the field. This ensures that knowledge is not lost,
but continuously built upon.
"Reprocessing of Instruments to Retain Value", nicknamed the "red book",

is the publication that AKI is best known for. As far as sterilization is
concerned, this red book, unlike the other little red book with quotes from
Mao Zedong, has contributed to a quiet, progressive and constructive
revolution. It has helped to improve reprocessing throughout the world
and has doubtlessly saved countless unnamed lives. There is no doubt
that its availability in 20 different languages has played a major role in
this. The ability to read it in one's own language helps to ensure a better
understanding. Understanding is necessary for knowledge. Knowledge is
necessary for change and improvement.
Wim Renders
Honorary President, World Federation for Hospital Sterilization Sciences

(WFHSS)

Foreword
Instruments are a major asset and represent a significant share of the
total capital spending of a hospital. It is a daily challenge to reprocess
these in a manner that is safe and conducive to their long-term use. The
practical experience recorded in this booklet, together with a description
of fundamental interrelationships, is intended to help users to keep
their reusable instruments in good working order and preserve their
value for many years, by ensuring proper reprocessing. It should be
emphasized that the recommended measures must always be carried out
in accordance with the manufacturer's instructions, pertinent national
hygiene requirements and official safety-at-work guidelines. In the interest
of preserving the value of instruments, it may be advisable to go beyond
national standards.
Instrument reprocessing is increasingly subject to medical product
legislation and is standardized in many countries.
In addition, there are direct legal requirements that need to be observed,

e.g. the German "Betreiberverordnung" (Operator Regulations), which
implements the Medical Devices Directive (MDD). They provide detailed
instructions for the reprocessing of medical products in the form of
validation measures. Compliance with such requirements can best be
assured and documented within the context of a quality system (QS).
As this "Red Booklet" has a distinctly process-oriented structure based on
the reprocessing procedures and references the provisions of
DIN EN ISO 17664, it can be incorporated directly into a process-oriented
system.
This 11th edition contains extensive updates.

For instance, the booklet now contains information on the reprocessing of
instruments used in robot-assisted surgery New knowledge gleaned from
both practical experience and laboratory testing have provided the basis
for various new sections, and the requirements of updated standards have
also been included in the booklet.
The glossary has been expanded to include further terms and definitions.
A cross-check has also been conducted comparing reprocessing

procedures focused on retaining the value of instruments against US
AAMI* standards. This has resulted in a number of additions the
"Red Booklet" at various points.
* Association for the Advancement of Medical Instrumentation

Introduction
Each section starts with handling instructions for surgical instruments,
including general instructions for the product groups described below.
Special instructions for these product groups are given under the
following symbols:
Surgical instruments Flexible endoscopes

and accessories
Microsurgical Flexible instruments and

instruments respiration systems
* For detailed information relating to prepro-

cessing of dental instruments, please refer to
Dental instruments*
the yellow AKI booklet "Proper Reprocessing
of Dental Instrument".
Surgical motor systems
Minimally-invasive surgery instruments,

robotic instruments, rigid endoscopes and
instruments for high-frequency surgery (HF)
However, one should keep in mind that these product-specific instructions

must always be seen in the context of the general instructions given for all
instruments in a particular section.
A wide-spread misconception that "high-grade steel" or "stainless steel"

are virtually indestructible and extremely durable needs to be corrected:
even stainless steel can be adversely affected by a wide range of potential
attacks – whether mechanical, thermal or chemical.
Nonetheless, as long as you understand the material and its characteristics

and know how to handle these products, you will be able to extend the
trouble-free life of your stainless steel instruments.
Microsurgical instruments require particularly careful reprocessing. Due to

the requirements of the applications, these instruments are very delicate
and incorporate very delicate and fine filigree parts.
Dental instruments also need special care due to their great variety and the
particular materials used in each case.

The same applies to individual components of surgical motor systems,
with this booklet addressing those that may be used only under sterile
conditions and therefore need to be cleaned and resterilized after use, such
as hand-held battery and compressed-air driven devices or handpieces.
Other instrument groups for which special processing instructions are

provided in this guide are MIS instruments, robotic instruments, rigid
endoscopes, HF instruments, flexible endoscopes and flexible
instruments.
Needless to say, users of medical devices expect well-known manufacturers

to exercise the greatest of care in both selecting the right materials and
manufacturing the product. Because of this, the user can count on medical
products that are optimally adapted to the intended purpose and provide
excellent functionality. However, to retain the value of the instruments in
the long run, users must make a significant contribution, i.e. by ensuring
correct reprocessing and care. To explain how this is done is the purpose of
this booklet.
Disposal instruments Medical products should only be reprocessed if the relevant manufacturer
has specified that it is appropriate to do so and if the manufacturer has
provided instructions to this end.
General notes and Basically, the reprocessing of medical devices comprises:

instructions n Preparation (pre-treatment, collecting, pre-cleaning and, where
applicable, taking the instruments apart),
n Cleaning, disinfecting, final rinse, drying (if required),
n Visual inspection of cleanliness and condition of material,
n Care and repair where required,
n Functional test,
n Marking,
n Packaging,
n Sterilization,
n Approval,
n Storage.
National regulations, such as the German Operator Regulations relating to

medical devices and the recommendations of the Robert Koch Institute
(RKI) entitled:
"Anforderungen an die Hygiene bei der Aufbereitung von
Medizinprodukten" [Hygiene requirements to be observed when
reprocessing medical devices], demand quality control and assurance in
these processes. It is the owner's/operator's responsibility to evaluate the
risks, to classify the various risk areas, to provide written standard work
instructions that clearly define each step in the reprocessing process
and to ensure adequate documentation. Validated cleaning, disinfecting

and sterilization processes, supplemented by defined configurations
for loading the washers/disinfectors (W/D) and sterilizers, are an
indispensable prerequisite for quality assurance.
It is particularly important to follow the manufacturer's instructions

in the instruction manual, not only because ignoring them might
lead to expensive replacements or repairs, but also because incorrect
reprocessing or product failure might endanger the patient or third
parties. We urge you to consult the manufacturer if you have any doubts.
For thermostable medical products, machine-cleaning with thermal

disinfection and steam sterilization are the preferred methods.

1. Materials and Design
1.1 Materials
When producing medical devices, the manufacturer must engineer them
to be fit for their intended purpose not only in design, manufacture and
finish, but also by selecting adequate materials suitable for the intended
use, potential reprocessing procedures and process chemicals to be used.
For surgical instruments generally only stainless steel (hardened,

non-rusting) can meet the tough requirements in terms of elasticity,
tenacity, rigidity, blade characteristics, resistance to wear and maximum
corrosion resistance.
Corrosion Resistance/ The corrosion resistance of stainless steel primarily depends on the
Passive Layer formation, thickness and integrity of the passive layer. This natural coating
is a protective layer of iron/chromium oxide that results from the chemical
Glossy/
polished reaction between the chromium in the steel alloy (at least 12%) and
oxygen in the ambient air. This layer is not affected, as long as the surface
topography of the product (matte or high-gloss) is suitable. In fact, its
formation and morphology are influenced by the following factors:
Matte/
brushed
n The material composition, alloy and purity,
n Microstructure of the material, which is influenced by heat treatment
(e.g. forging, tempering, annealing, welding, soldering, laser engraving),
Matte/pearl n Surface condition, e.g. roughness, topography, flawlessness and
matte
cleanliness,
n Handling and reprocessing conditions,
n The service life and number of reprocessing cycles,
Surface finishes on instruments
n Instrument labeling (e.g. laser engraving, electrochemical markings,
embossing).
Chlorides are dangerous Passive layers are extremely resistant to many chemical substances.
Depending on the factors mentioned above, on every passive layer there
are areas with a specific crystallographic structure where the passive layer
is very susceptible to corrosive attack, particularly when in a damp or
aqueous environment. Among the few substances that can attack and
destroy this layer are halogen salts (halides), the most common and
Scanning electron microscope image,
chloride-induced pitting
dangerous of them being chlorides. Chlorides tend to react with the
passive layer in a process leading to the well-known, chloride-induced
damage called "pitting". Depending on the concentration of chlorides, the
damage caused ranges from a few sparse points of attack (visible as small
dark dots) to a completely damaged instrument surface covered with
large deep holes. Chlorides also cause "stress corrosion cracking".

Technical measures such as chemical passivation implemented by the
manufacturers, supported by processes such as dip processing in a citric
acid mixture and the natural aging process, ensure that the passive layer
becomes more resistant (provides more protection from corrosion). Where
there is mechanical damage or wear, this optimized passive layer is also
destroyed in certain areas, only to be replaced by a natural passive layer
(see page 14) resulting from a form of "self-healing" caused by
re-passivating.
Experience has shown that a newly applied technical passive layer is
superior to a natural passive layer that has been damaged in certain areas,
because it reduces the likelihood of chlorides penetrating it through to
the unprotected base material.
Tweeters in detail: Transition between spring Chloride sources in the instrument usage and processing cycle:
and grip surface.Reactivation salt containing
n Fresh-water chloride content (depending on the source of the supply).
chloride caused massive pitting on the surface
of the instrument. Leaking ion-exchanger n Insufficient demineralization of the water used for the final rinse and
connection in the W/D.
steam sterilization.
n Reactivation salt carry-over, leakage or spillage from ion exchangers
used for water softening.
n Use of agents not permitted for or incorrectly used during reprocessing.
n Isotonic solutions (such as physiological salt solutions), etchants and
drug residues.
n Organic residues (body fluids such as blood, chloride
content 3,200-3,550 mg/l, saliva, sweat) dried on the surfaces.
n Laundry, textiles, packaging materials.
Regardless of whether the instrument has a "matte" or "glossy" surface

and how the passive layer is formed, pitting and stress corrosion cracking
do not occur (or at most only occur rarely) in environmental conditions
with no or little chloride content.
If corrosion occurs on new, high-quality instruments processed in the
same cycle with older instruments, the reason was found in all cases
investigated so far in the instrument reprocessing conditions, where
individual or several treatment steps had taken place under conditions
that approached or exceeded the limits of process reliability.
As well as hardenable martensitic chromium steels, standardized non-

hardenable chromium steels with modified chromium contents and rust/
acid-resistant chromium-nickel steels, each classified as being of stainless
steel quality, are also used to make instruments in accordance with
EN ISO 7153-1 and EN ISO 16061. Their mechanical properties are limited
Color etching – martensitic structure however, so that the use of these steels is restricted to certain types of
(500x magnification)
instruments. The mechanical properties of products made from these also
remain unaffected even after any number of reprocessing cycles.

For instruments used in endoscopy and minimally invasive surgery, a great
variety of materials is employed, depending on the given application
technique and the particular instrument design. The most important of
these are:
n Rust/acid-proof chromium-nickel steels (also as welding filler),

n Pure titanium or titanium alloy,
Color etching - austenitic microstructure n Cobalt-chromium alloys,
on rust and acid-resistant instrument steel
(500x magnification) n Carbide metals, such as sintered metal, tungsten carbide with nickel
binding phase, cobalt-chromium base alloy,
n Non-ferrous heavy metal alloy with surface finishing (e.g. chromium-/
nickel-plated brass). However, these are used only rarely today.
n Coatings (e.g. titanium aluminum nitride, titanium aluminum
carbonitride, zirconium nitride and titanium nitride,
n Light metals (e.g. anodized aluminum),
n Noble metals (e.g. silver),
n Non-corrosion-resistant steels (e.g. for coated assemblies and
components),
n Glass (for optical systems),
n Ceramics,
n Cements and other adhesives,
n Solder,
n Plastics and rubber.
Special processes may The combination of these very different materials in a particular
be required depending on instrument places restrictions on reprocessing. These items may therefore
the material combination require special treatment that varies from the standardized instrument
used. reprocessing procedure. Such treatment is described in the manufacturer's
instructions.
The design and application requirements of flexible instruments and

respiration systems also make it necessary to combine a variety of
materials Here, the most frequently used materials are rubber and latex
(based on natural rubber) and various synthetic materials, especially
silicone elastomers (or silicone rubber).
For flexible endoscope, combinations of highly flexible polyurethane
hoses, adhesives, lenses, optical fibers and more are used.
For surgical motor systems, the full range of materials described in this
guide is used, because of the design and manufacturing requirements
involved. Stainless, heat-treatable chromium steels, for example, are
used for drill bits, cutters, burrs, saw blades and gear components, while
sterilizable plastic materials are usually used for handles, switches, gear
components or cables and flexible tubes.

Special reprocessing treatment methods may be necessary for varnished
housing made of unalloyed sheet steel, handpieces with colored
graduations (indicating gear ratios) or anodized aluminum housings
(as used for handpieces and elbows). For appropriate treatment
recommendations, please refer to the manufacturer's instructions. In
addition to special reprocessing treatments, lubrication is also essential
for heavy-duty shafts as well as for bearing and gear components made
of stainless steel (and in some cases, also for those made of non-stainless
quenched and tempered steels or bronze materials).
1.2 Design
The capacity for reprocessing medical products is of extreme importance
for patient and user safety. During the design and development stage
of a medical device it is necessary to consider its capacity for good
reprocessing after use. However, the focus must be not only on the
capacity for reprocessing, but also on correct functioning. Often, the
mechanism required must be accommodated in the tiniest of spaces in
order to avoid patient discomfort.
Optimum cleaning results can be achieved if the medical product can be

dismantled as much as possible. But there are limits here too. It is only
possible to dismantle many medical products with great difficulty, for
example articulated instruments used in minimally invasive surgery with
diameters of less than 3 mm, because users & reprocessors are unable
to dismantle and reassemble these ultra-thin components. Another
important point is the choice of materials and joining techniques. Joining
methods such as welding and soldering are designed to avoid affecting
the mechanical and corrosive properties of the product over the course of
its service life.
Because fractional steam sterilization is the most commonly applied

sterilization method and is the most damaging for many non-metallic
materials, suitable materials must be selected.
To achieve optimum reprocessing results, close cooperation is essential

between all the parties involved: from the medical product manufacturer,
the manufacturers of automatic washers/disinfectors and sterilizers, to the
manufacturers of process chemicals. When purchasing medical products,
it is recommended that those responsible for reprocessing instruments are
included in the process at an early stage.

2. Media used for instrument
reprocessing
2.1 Water
The quality of water used for instrument reprocessing has a considerable
influence on value retention.
Water fulfills a variety of functions in the treatment process, including:

n As a solvent for cleaning agents and other process chemicals,
n Transferring mechanical forces and heat to the instrument surface,
n Dissolving water-soluble dirt and impurities,
n Flushing process chemicals,
n Thermal disinfection for machine-cleaning and disinfection,
n Medium for steam sterilization.
Use correct water quality! Unfavorable water composition can have an adverse effect both on
the reprocessing procedure and on the appearance of the instruments
and materials. This is why water quality in sufficient quantity is already
important when planning on-site plumbing installations.
Water constituents and their influence in reprocessing
While any natural water contains dissolved salts, The nature and
concentrations present in drinking water vay depending on the source of
the water and how it is collected.
The water constituents may cause the following problems:
Minerals causing water hardness Scaling, lime deposits due to
(calcium and magnesium salts) calcium and magnesium salts,
corrosion potential
Heavy and nonferrous metals, Brown-red deposits, secondary rust
e.g. iron, manganese, copper
Silicates, silicic acid White-grey, colored appearance,
thin scaling
Chlorides Pitting
Evaporation residue Spotting and scaling
Apart from its natural constituents, drinking water sometimes contains

rust, generally flushed from corroded pipework. During the reprocessing
cycle this rust tends to adhere to instruments, causing rust spots
(extraneous rust) and subsequent corrosion.

Aluminum might be Minerals causing water hardness
attacked by softened Depending on water hardness and temperature, minerals causing water
water. hardness can lead to the formation of a hard layer (lime deposits, scale)
that is difficult to dissolve. It is even possible for corrosion to occur
underneath such deposits.
Heavy and nonferrous metals

Heavy and nonferrous metals and their compounds in the water can lead
to colored scaling even at low concentrations. High quantities of iron
dissolved in water can cause corrosion on surfaces (secondary rust).
Image page right: Corrosion of black anodized
instrument surfaces by softened water. Silicates
Silicic acid and silicates may cause white-gray, yellowish brown or bluish
purple discolorations even at low concentrations.
Chlorides are dangerous Chlorides

Chlorides dissolved in the water are particularly critical substances, as
they tend to cause pitting even on stainless steel instruments if present in
higher concentrations.
The danger of chloride-induced pitting generally rises with:
n An increase in the chloride content,
n An increase in temperature,
n Declining pH value,
Chloride-induced pitting on n Increasing exposure time,
instrument.
n Insufficient drying,
n Concentration of chloride resulting from adherence of dry residues to
instrument surfaces after evaporation.
While the causal relationships between the chloride content of the water
and pitting are not always predictable, laboratory testing has shown sign
of corrosion on instruments after just two hours with a chloride content of
100 mg/l at room temperature. As chloride concentrations increase, the risk
of pitting also increases rapidly.
Evaporation residue
When water evaporates, some substances contained in it remain as visible
Evaporation residue. These may result in spotting and/or corrosion. Owing
to the substances in the water, the natural drinking water cannot be
recommended for all reprocessing steps. Depending on the application,
drinking water should be softened or demineralized by means of
reprocessing procedures described in more detail below.

Water treatment methods
Water softening
In the water softening process, the calcium and magnesium cations, which
are the substances causing the water hardness, are replaced by sodium
ions. However, this does not reduce the overall load of evaporation residue
(including chloride content) in the water. When using softened water,
alkalinity can greatly increase due to the formation of sodium carbonate
depending on the temperature, time and carbonate hardness in the initial
water.
Full demineralization
In the full demineralization process, all mineral substances are largely
removed from the drinking water. The methods used to do this are
reverse osmosis, cation & anion exchangers, and electrode ionization, a
combination of the above, and also distillation in special cases.
Substances in water, such Comparison of example water qualities:

as silicic acid, may cause Drinking
Softened water
Demineralized
water water
discolorations.
Evaporation residue (mg/l) 500 530 5
Elec. conductivity (µS/cm) 650 700 3
Total hardness (°d) 14 < 0.1 < 0.1
Sodium salts (mg/l) 20 160 <1
Chlorides (mg/l) 40 40 <1
Silicates (ppm SiO2) 12 12 < 0.1
pH value 6.7 8 5.5
Requirements for water qualities:

Stain pattern caused by silicic acid in
steam condensation. Special requirements in terms of water quality may need to be met
depending on the reprocessing step being executed (see chapters 6, 7
and 10).
Softened water:
Based on experience in machine-based instrument reprocessing, the
following guide values are recommended:
Total hardness: < 3 °d (< 0.5 mmol CaO/L)
Evaporation residue: < 500 mg/l
Chloride content: < 100 mg/l
pH value: 5-8
Attention: When using softened water, especially when applying thermal

disinfection, corrosion may develop on instruments and anodized aluminum
surfaces might be subject to attack due to an increased pH value.

Attention: Where chloride content exceeds 50 mg/liter and cleaning
parameters are unfavorable (low pH value, elevated application
temperature and exposure time), the risk of pitting cannot be eliminated
for stainless chromium steels.
Use fully demineralized Demineralized water:

water for the final rinse! Since there is currently no specific standard for demineralized water in
machine-based or manual cleaning and disinfection, the application of
the boiler feed water quality as defined in DIN EN 285, Appendix B is also
recommended for this process step. Despite the requirement specified in
EN 285, empirical data has shown that a conductivity value of around
15 µS/cm is sufficient for manual and machine-cleaning and disinfection.
Application guidance:
We recommend using demineralized water for the final rinse
for the following reasons:
n No spotting.
n No increase in concentration of corrosive constituents, e.g. chlorides.
n No dried crystalline residues which could have a negative effect on the
downstream sterilization process.
n Protection and stabilization of anodized aluminum surface
To optimize the process and to achieve consistent quality of results, we
recommend that you use fully demineralized water at all steps of the
program.
For steam sterilization, limit values for feed water quality as specified in
EN 285 and ISO 17665 are required:
Contamination in the supply water to an assigned steam generator

Substance/property Feed water
Evaporation residue ≤ 10 mg/l
Silicates (SiO2) ≤ 1 mg/l
Iron ≤ 0.2 mg/l
Cadmium ≤ 0.005 mg/l
Lead ≤ 0.05 mg/l
Heavy metal residues, except for iron, cadmium, lead ≤ 0.1 mg/l
Chlorides (Cl-) ≤ 0.5 mg/l
Phosphates (P2O5) ≤ 0.5 mg/l
Conductivity (at 20 °C)* ≤ 5μS/cm
Note: Recognized analytical procedures must be pH value (degree of acidity) 5 to 7.5
used to ensure compliance. Appearance colorless, clear, no
Source: DIN EN 285: 2016-05 (EN 285:2015, deposits
Table B.1) Hardness (Σ of alkaline earth metal ions) ≤ 0.02 mmol/l
If ion exchangers are used in the production of fully demineralized water,

glaze-like discolorations may occur as a result of silicic acid passage
(see chapter 12.4). To ensure that instruments can be reproducibly kept
spot-free, the silicate content should be consistently below 0.4 mg/l.
Quality monitoring of the fully demineralized water by way of monitoring

of electrical conductivity is not adequate for identification, as the silicic acid
does not imbue the water with conductivity. For this reason, it is advisable
to periodically measure the silicic acid content using a quick chemical test.
Practical experience has shown that silicic acid passage may occur even
at electrical conductivity of approximately 1 µS/cm. To minimize this risk,
an inline configuration of two mixed-bed ion exchangers has proved
successful. This inline configuration downstream of a reverse osmosis unit
optimizes the production of fully demineralized water with no silicic acid
content.
Qualified personnel should be consulted in any case.
In order to meet requirements in terms of the microbiological qualities

used in instrument reprocessing, national recommendations should be
followed.
2.2 Process chemicals
Process chemicals used to reprocess medical instruments must be

developed, tested and manufactured in Europe in accordance with the
European Medical Devices Directive.
n Cleaners, neutralizers, rinsing and care agents are classified as class I

medical products and are identified by the CE mark on the label.
n Process chemicals exerting a disinfecting effect are classified as
class II a for the disinfection of medical products and class II b for the
disinfection of invasive medical products. This are linked by a CE mark
with a four-digit number identifying the responsible Notified Body.
Outside of Europe, the relevant national regulations must be observed.
The producers of process chemicals must provide evidence of and

document claimed properties such as cleaning, disinfection and care, and
also regarding the biocompatibility of residues. This is part of the product
documentation that is required to achieve a CE mark.
The producer of the process chemicals must provide evidence of
compatibility with materials, if necessary in cooperation with the
manufacturer of the corresponding medical instruments. The bio-
compatibility of potential process chemical residues must be tested and
assessed in accordance with ISO 10993 "Biological Assessment of Medical
Devices".

Optimum application properties and the material compatibility of the
process chemicals are assured only under the application conditions
recommended by the manufacturer. Material compatibility is heavily
dependent on temperature and concentration. Attacks are possible, for
instance on coatings or anodized surfaces, depending on the reprocessing
procedure. The producer must describe the application conditions
and product properties in a relevant document in detail (on the label,
product information, safety data sheet) and users must observe these
instructions. Special attention must be paid to the concentrations of the
process chemicals in the application solutions and to the temperature and
exposure time.
The ingredients of various process chemicals may interfere with one

another. For example, in a machine process the constituents of a cleaning
agent can have a negative effect on the effectiveness of a disinfectant if
they are entrained into the downstream disinfection step. As this aspect
must be taken into consideration by the manufacturers of the process
chemicals in testing effectiveness, it is recommended that only process
chemicals designed to be used together from a single manufacturer be
used in a self-contained machine-cleaning & disinfection cycle. Ingredients
of pretreatment agents may also inferfere with process chemicals used
in a machine-based process, potentially resulting in the formation of
deposits. It is recommended to take note of the information provided by
the producer.
2.2.1 Types of process chemicals

Pretreatment agents
Pretreatment agents may be cleaning agents or anti-microbial products
– e.g. bacteriostatic or disinfectant – which are applied prior to a manual
or preferentially machine-based cleaning and disinfection procedure, for
example as foam sprays, wet disposal products, etc.
Detergents
Using cleaning agents restricts contamination of a medical product to a
degree necessary for further reprocessing or application. Cleaning agents
are employed for both manual and automated cleaning and disinfection
procedures. A basic distinction is made between:
n pH-neutral cleaning agents with/without enzymes,
n mildly alkaline cleaning agents with/without enzymes,
n alkaline detergents with/without tensides.

There are also combined lab cleaning agents that both clean and disinfect.
Material compatibility is dependent not only on pH value, but on the
overall composition of the cleaning agent and the circumstances under
which it is applied. Therefore, all of the specified cleaning agent types may
have stated material compatibilities.
Disinfectants
Disinfectants are employed both for manual and – preferentially –
automated cleaning and disinfection to perform final disinfection
(see chapter 7) on heat-sensitive medical products such as flexible
endoscopes. Disinfectants contain anti-microbial agents and combinations
of such agents. They reduce the number of viable micro-organisms on a
surface to a level suitable for further handling or use.
Neutralizers
Acidic substances based on citric acid or phosphoric acid which can be
added to the initial rinsing water in machine-cleaning and disinfection
following alkaline cleaning in order to neutralize alkalinity and enhance
rinsing of the cleaning agent. Neutralizers may also be used to present
spotting and support the formation of passive layers.
Rinse aids
Rinsing agents are added to the final rinsing water in a machine-based
cleaning & disinfection procedure to achieve more effective, faster drying.
The agents in the rinsing agents reduce the surface tension of the rinsing
water and so minimize adhesive residual moisture.
Care products
Care products for surgical instruments with metallic friction surfaces
which need oiling are made of paraffin oil (paraffinum perliquidum) and
emulsifiers. Other care products, such as for anesthesia utensils, may also
be silicone oil-based.
2.2.2 Properties and assessment of constituent

substances
Caustic alkalis
may be constituents of alkaline cleaning agents (calcium hydroxide,
sodium hydroxide) and decompose organic dirt residues by their alkalinity.
Anti-microbial agents
Aldehydes such as formaldehyde, glutaraldehyde and ortho-
phthalaldehyde, are preferentially used for final disinfection at
temperatures up to 60 °C. In this temperature range they are usually
highly compatible with instrument materials. Due to their fixing properties

on proteins, combined cleaning agents and disinfectants based on these
agents are not recommended for cleaning.
Alcohols are used in large quantities in disinfectants as anti-microbial

agents, or in smaller quantities as solvents. Most instrument materials
are highly compatible with alcohols at room temperature. When using
aromatic alcohols, such as phenoxyethanol, at higher temperatures for
final disinfection damage to adhesive compounds has been described,
especially in the case of flexible endoscopes.
Alkylamines aid cleaning in addition to their anti-microbial effect. As

a result, they are particularly well-suited for use in combined cleaning
agents and disinfectants. In this group of agents, material compatibility
– particularly with elastomers and adhesive compounds – is heavily
influenced by the chemical structure of the agent, which means some
products cannot be used to reprocess flexible endoscopes. In the case
of silicone elastomers, extended treatment with alkylamine-based
disinfectants may lead to hardening.
Chlorine dioxide is used for final disinfection, particularly of flexible

endoscopes, in disinfectors as a two-component system. Depending on
the product composition, changes in the material of endoscopes, such
as discoloration of the black insertion section, are possible which may
be merely of a cosmetic nature. Shortened service lives of plastics and
adhesive compounds cannot be ruled out if this agent is used, depending
on the usage conditions.
Depending on pH value, peracetic acid and its salts can be used both
as combined cleaning agents and disinfectants and as final disinfection
products. Material compatibility depends heavily on the composition of
the disinfectant and on the operating conditions, such as pH value, agent
concentration, and temperature. For this reason, the tested and validated
instructions of the manufacturers must be strictly observed.
Quaternary ammonium compounds and guanidine compounds are

preferentially used in combined cleaning agents and disinfectants. They
exhibit good material compatibility. Agents from this substance group
tend to be adsorbed on plastic surfaces, which can result in scaling if
surfaces are inadequately rinsed after cleaning. Due to their range of
effects, using only agents from this substance group for final disinfection
is not recommended. If these agents are used for final disinfection in
combination with aromatic alcohols at higher temperatures, damage to
adhesive compounds in endoscopes has been described.

Hypochloride acid is formed in automatic disinfection machines by
an electrolysis process and is used for final disinfection, especially for
flexible endoscopes. Material compatibility depends heavily on the pH
value of the application solution and on the concentration of the agent.
Depending on the operating conditions, shortened service lives of plastics
and adhesive compounds cannot be ruled out if this agent is used.
Hydrogen peroxide is used in isolation or in combination with peracids in

combined cleaning agents and disinfectants, in final disinfection products,
and for low-temperature sterilization. At room temperature, this agent
demonstrates good material compatibility in conventional concentrations,
although the special conditions of low-temperature sterilization processes
(temperature & concentration) may affect material compatibility.
Enzymes
such as protase, amylase and lipase are proteins which catalytically
decompose contaminants such as protein, carbohydrates and fats under
mild application conditions, making them soluble in water.
Complexing agents
deactivate substances causing hardness in the water and support the
cleaning effect in cleaning agents.
Oxidation agents
are based on hydrogen peroxide or on sodium hypochlorite, for example,
and are able to decompose particularly stubborn organic contaminant
residues.
Paraffin oil
A care constituent of instrument care products used to prevent friction
corrosion on instruments with metallic friction surfaces.
Phosphates
Phosphates are used to soften water. Their contaminant-carrying capacity
supports the cleaning process.
Phosphate substitutes
Phosphate substitutes such as gluconates and phosphonates absorb
water-based minerals but can only partially substitute the assistance that
phosphates provide in cleaning.
Acids (citric or phosphoric acid)

Citric and phosphoric acid preparations are used as neutralizers, but can
also be used as complete acidic cleaning components in machine-based
reprocessing procedures.

Silicates
provide corrosion protection, such as for light metals, in alkaline cleaning
agents.
Silicone oils
are recommended as care substances for anesthesia utensils.
Tensides
Tensides in detergents reduce the interfacial and surface tension of water,
assist cleaning with their emulsive and dispersive effects, and prevent
redeposition of contaminants. Suitable tensides in machine cleaning
agents inhibit form formation, which may occur for instance when high
amounts of blood are present. Tensides are also a major component of
rinsing agents to reduce interfacial and surface tension, which ensures
that water runs off better, thereby improving the drying of the rinsed
product.
3. How to Treat Brand New and

Repaired Instruments
Preparation Brand new instruments, including their instructions for use, and
instruments returned from repair must be routed to the Reprocessing
Unit for Medical Products as soon as possible and removed from their
transportation packaging before storage and/or introduction into the
instrument usage and processing cycle. Any protective caps or foils must
also be removed.
Before using brand-new and repaired instruments, they must be sent
through the entire reprocessing cycle in the same manner as used
instruments. The number of cycles is dependent on the manufacturer
specifications.
Cleaning is mandatory! This cleaning step should never be skipped, because residues on
instruments (e.g. from packing materials or care agents) may result in the
formation of stains or deposits during sterilization.
Always visually inspect cleaning results. As a rule, the instruments should
be visibly clean after the cleaning stage.
Where the passive layer of brand-new instruments is still thin, these
instruments may be more sensitive to critical reprocessing conditions
than older, used instruments. Some manufacturers recommend that they
undergo cleaning and disinfection (washing) several times.

Storage Brand new instruments and instruments returned from repair must be
stored only at room temperature in dry rooms or cabinets. Otherwise
condensate may build up inside plastic packages as a result of temperature
fluctuations. This may cause subsequent corrosion damage.
Instruments should never be stored near chemicals, such as active chlorine,
which emit corrosive vapors.
To avoid mechanical damage during reprocessing, microsurgical

instruments should be stored in suitable racks or holders, even after being
reprocessed for the first time.
Flexible instruments must be stored in their original packaging in a dry,

cool and dark place. When restocking your supplies, keep in mind that
flexible instruments made of rubber or latex will age even if stored unused.
Functional parts of respiration systems frequently incorporate valves or

diaphragms which tend to become blocked by internal surfaces sticking
together during longer storage periods. Always test valves or diaphragms
before using instruments.
4. Procedure Recommendations for

Returned Goods
In our context, returned goods are defined as packaged medical devices
which, irrespective of whether they have been used or not, are returned to
the manufacturer.
The reasons for return can be manifold: necessary repairs or servicing, return
of leased instruments, for checks to be carried out on products that are being
clinically tested, in the case of complaints, return of removed implants for
scientific investigation or damage analysis, etc. Return shipments must be
carried out promptly, in accordance with the manufacturer's instructions.
Note that there is a risk of infection for anyone dealing with products that are
actually or potentially contaminated. It is most important to minimize this
risk by implementing adequate and reliable treatment processes.
The above guideline implies that goods may be returned only if:
n they have been cleaned, disinfected and dried in accordance with the
manufacturer's instructions, and have been declared hygienically safe, or
n they are visibly marked as "non-decontaminated" and delivered in
sufficiently safe packaging.
The decontamination of products to be returned should be carried out as
soon as possible after use, as if they were undergoing their normal cycle.
This prevents subsequent damage to the instrument (e.g. pitting caused
by blood chlorides).

However, decontamination is not indicated where such treatment would
alter or destroy the product, prevent proper analysis, or distort its results. If
in doubt, consult the manufacturer of the product.
Possible procedural options include the enclosure of an individual or

collective declaration containing all the information required.
This type of collective declaration (such as the BVMed notice in Germany,

see literature reference no. 31) given to the manufacturer or other
receiving or processing entity should at least contain the following
information:
n Date of manufacture/validity.
n Confirmation that from that date onwards all goods returned can
be considered hygienically safe unless clearly and visibly marked
otherwise.
n Contact details to enable the clarification of any questions concerning
the goods and the receipt of returns.
In addition, the following information on the individual medical product

must be included in the accompanying documentation:
n Application of the medical product,
n Decontamination method
n Date of reprocessing,
n Name of reprocessor(s),
n Reason for return.

5. Preparation for Cleaning and
Disinfecting
The first steps in a proper reprocessing cycle are taken in the operating
theater. Coarse contaminants, residues from hemostatics, skin
disinfectants and lubricants, as well as caustic drugs should, wherever
possible, be removed before the instruments are set down.
Chlorides are dangerous Never immerse stainless steel instruments in an isotonic solution
(such as physiological saline solution). This is because prolonged
instrument contact with saline solution leads to pitting and stress
corrosion cracking.
Careless dropping can also damage instruments. For example, the

hardened (tungsten carbide) tips of scissors may come off, or small
clamps may be bent. To avoid damage, always put your instruments down
carefully after use. Do not overload instrument trays.
Corrosion caused by immersion in physiological
salt solution over a period of several hours
Waste, skin disinfectant residues, saline solutions etc., may not be put in
disposal containers.
In hospitals with a Reprocessing Unit for Medical Products, self-contained

systems are used to transport contaminated medical products from the
operating theaters and wards to the unit. Dry disposal always preferable as
a more conservative method aimed at retaining value.
Wet disposal involves damp cloths being placed on the instrument trays
during transport or the use of an appropriate foam spray. The damp
Deformation caused by improper conditions increase the risk of corrosion and may encourage the growth of
handling
microorganisms.
When using wet disposal, it is advisable to immerse the instruments in a

cleaning agent or combined cleaning agent and disinfectant that has no
protein-fixing effect. Disinfectants containing aldehyde should be avoided
as they have a fixing effect.
As regards concentration and exposure time, as well as the addition of

cleaning intensifiers, the manufacturer's specifications should be noted at
all times.
Avoid long intervals Because of the corrosion risk and the cleaning factors, long intervals
between use and between instrument use and reprocessing (e.g. overnight or over the
treatment for reuse! weekend) should be avoided. Field experience has shown that in the case
of dry disposal, intervals of up to 6 hours pose no problem. Contamination
and pre-cleaning are factors that have a critical impact here.

For certain instruments, it is recommended that reprocessing commence
immediately, for instance for flexible endoscopes and robotic surgery
instruments.
The instruments must be placed into instrument carriers (e.g. trays, racks)
that are suitable for machine-based cleaning procedures.
Effective cleaning requires that articulated instruments (such as scissors,
clamps, forceps) be processed in the open position to minimize surface
overlapping. The trays, racks, holders, supports, etc., must be such that
subsequent cleaning in ultrasound basins or washers/disinfectors will not
be hampered by acoustic or spray shadows.
Complex instruments must be taken apart for cleaning in accordance with
the manufacturer's specifications.
Instruments not used for surgical intervention must be treated in the same
way as instruments that have actually been used.
Special racks, suitable storage holders and load carriers with special
rinsing equipment must be used for microsurgical instruments.
Dental materials adhering to dental instruments (such as filling materials

or acid cement removers) must be cleaned away immediately after use.
Otherwise, the material will harden on the instrument and/or cause
corrosion. Dental cements and composites should ideally be removed
directly after application, for instance with a swab.
Surgical motor systems must be taken apart immediately after use in

accordance with the manufacturer's specifications. If the manufacturer's
specifications call for special storage systems for automated cleaning
and disinfection, such systems must be used. Batteries not suited to
reprocessing must be removed from the motor systems.
Simple tools such as drill bits or saw blades can be processed in the same
way as surgical instruments, provided that they are not categorized as
disposable (single-use) medical products.
To avoid damage to sensitive instruments, they must be transported in

containers designated for this purpose with restraints. Shaft-based robotic
instruments are pre-filled with water or cleaning agent and immediately
transported for reprocessing. MIS instruments, endoscopes and HF
instruments that can be taken apart must be disassembled in accordance
with the manufacturer's specifications prior to reprocessing. Optics must
be placed in special containers.

Dried-on residues are particularly critical in the case of instruments used
in surgical endoscopy, because such deposits are difficult to remove from
small lumens, and may impair or destroy the functionality of joints. This
is why these instruments should always be processed immediately after
use. Where cleaning proves to be difficult using the available methods or
procedures, we recommend that HF instruments be pre-treated with a
hydrogen peroxide solution in order to remove any coagulated residues.
Deformation caused by improper handling HF instruments for robotics must not be treated with hydrogen peroxide
solutions. It is advisable to fill these instruments with enzymatic cleaning
agent solution prior to disposal.
Handles and cables for HF surgery can be pre-treated in the same way as
surgical instruments.
In the case of flexible endoscopes, the insertion part must be wiped with
a lint-free cloth immediately after use. This cloth should be saturated with
an instrument-cleaning or cleaner-disinfectant solution which has no
protein-fixing effect. To avoid encrustation and clogging, the discharge
duct as well as other channels should also be rinsed with the same
solution. To rinse the air/water channel, water from the rinsing bottle can
be used.
Before entering the next stage of reprocessing, a leak test must first be
carried out in accordance with the manufacturer's specifications. This
ensures the early detection of leaks and perforations and the prevention
of more serious damage (as could be caused by penetrating liquids).
A defective endoscope must be returned to the manufacturer
immediately, together with a description of the problem. If it has not
been sufficiently cleaned and disinfected, this must be clearly and visibly
indicated on the liquid-tight packaging.
Flexible instruments and respiratory systems must always be taken apart

(in accordance with the manufacturer's specifications) to ensure that they
are properly reprocessed for reuse. Make sure to handle cones, sealing
surfaces, threaded connections and valve plates carefully, protecting them
from mechanical damage.
Prior to reprocessing, absorbers must be checked for soda lime. Any such
residue found must be completely removed from the absorbers.
Sensors may only be treated in accordance with the manufacturer's

instructions.
When using wet disposal, flexible instruments with lockable cavities

(such as larynx masks, certain other masks) must be closed.

6. Manual and Automated Cleaning
and Disinfecting
6.1 Manual Cleaning and Disinfecting
Cleaning
For manual cleaning, active non-protein-fixing process chemicals with or
without anti-microbial effect and with or without enzymes are used.
When using cleaning agents, the manufacturer's specifications, especially

those regarding concentration and temperature, must be observed. The
cleaning/disinfecting solutions used should be freshly prepared on a daily
basis. If it becomes visibly contaminated, it is advisable to prepare fresh
solutions at even shorter intervals.
If solutions are used for too long, the following problems may occur:
n Reduced cleaning performance due to increased reintroduction of
contaminants.
n Risk of corrosion due to contamination and due to increased
concentrations caused by evaporation.
n Microbial development in the cleaning agent solution, thereby
potentially putting personnel at risk.
Disinfecting cleaning
When performing disinfecting cleaning, please also note that the
disinfecting capability should have been proven under "dirty conditions"
(high protein load) in accordance with European (EN) standards or
corresponding national regulations. When using disinfecting cleaning
agents, the producer's specifications regarding concentration,
temperature, exposure time and material compatibility must be observed.
The cleaning/disinfecting solutions used should be freshly prepared on a
daily basis. If it becomes visibly contaminated, it is advisable to prepare
fresh solutions at even shorter intervals.
If solutions are used for too long, the following problems may occur:
n Reduced cleaning performance due to increased reintroduction of
contaminants.
n Risk of corrosion due to contamination and due to increased
concentrations caused by evaporation.

Disinfection
In some countries, medical products are disinfected before sterilization
for occupational health & safety reasons (see chapter 15). In such cases,
disinfectants with proven disinfection effects are used. The disinfection
effect must at least have been proven under "clean conditions"
(low protein load) in accordance with European (EN) standards or
corresponding national regulations.
The disinfectant solution must be replaced as specified by the producer.
Dissolve powders If powdered products are used, the powder must be fully dissolved in the
completely! water in accordance with producer specifications before use. Only then
are the instruments placed in the solution. Suitable measures should be
taken to mitigate the risk of contact between undissolved particles and
instruments (e.g. disinfectant bath with sieve) to prevent changes to the
surfaces or blockages of narrow-lumened instruments.
We recommend using soft, lint-free cloths or towels, plastic brushes or

cleaning guns for cleaning. For cavity instruments, the type and size of
brushes recommended by the medical product manufacturer must be
used. Following manual cleaning or disinfection and cleaning, make sure
to rinse instruments adequately and thoroughly with clear running water.
This procedure removes contaminant residues that may still adhere to the
surfaces of the instruments.
Stains caused by high salt content of
rinse water
Water must be used to rinse the instruments, and must be at least
consistent with the microbiological quality of drinking water. For the final
rinse, fully demineralized water is recommended to prevent spotting. The
relevant water reprocessing systems must be serviced in accordance with
the manufacturer's instructions. The instruments must be dried thoroughly
immediately after rinsing. Drying using oil-free compressed air is especially
conservative and effective, which is why it should be preferred over other
drying methods such as drying with a cloth.
The main reasons for mechanical damage during manual reprocessing

include:
n Use of metal brushes,
n Use of coarse scouring agents,
n Use of too much force,
n Dropping or bumping of instruments.
Articulated instruments must be placed into the solution open, thus

minimizing obscured surface area. Narrow-lumened instruments such as
flexible tubes and cannulas, and instruments incorporating cavities require
greater attention to process. It is important to make sure that the internal
surfaces are thoroughly and completely in contact with the solution.

Dental instruments can usually be treated in the same manner as surgical
instruments. For dental instruments requiring special reprocessing, please
see the following instructions:
Handpieces, elbows and drive systems that cannot be submerged in an
immersion bath undergo disinfection by wiping from the outside (e.g. using
a suitable surface cleaner-disinfectant). As regards cleaning their internal
surfaces, and taking appropriate maintenance and care measures, observe
the manufacturer's specifications.
Dental instruments with rotating components not manufactured from

stainless steel may be immersed only in special disinfecting and cleaning
solutions that are specifically suitable for their materials. To prevent
corrosion, a short rinse is followed by immediate drying and treatment with
an anticorrosive agent suitable for sterilization. In the case of ceramic or
plastic-bonded abrasive tools, check first whether the cleaning agents used
are suitable for these instruments.
Instruments for root canal treatment are highly susceptible to mechanical

damage and should therefore be reprocessed separately and placed in
special stands for handling purposes. For cleaning and disinfecting remove
the silicon stoppers in order to adjust the depth of preparation. Alkaline
solutions may attack instruments used for root canal treatment with
colored, anodized handles and may destroy their color-coding function.
Motor systems must be wiped with a cleaning surface disinfectant. Apart

from lint-free cloths, soft brushes can also be used for cleaning in these
cases. After spraying the surfaces with a disinfectant and allowing time for
the spray to take effect as specified by the manufacturer, the surfaces are
Avoid ingress of liquids! wiped clean. Following cleaning and disinfecting, make sure to rinse the
surfaces under running water, Operating instructions must be noted to
allow the entry or liquids, cleaning agents or disinfectants into lumens and
cavities.
For battery-powered devices, check whether the manufacturer's

specifications require and allow cleaning and disinfection of the batteries.
Contact between the battery's contact and electrically conductive objects
(instruments, sieve baskets) or liquids must be avoided.
When using compressed air to dry machines and handpieces, make sure
that you never point the compressed air gun at bearing seats or at the
seals, since such action can damage the bearings and seals. Simple reusable
tools can be treated like surgical instruments.

MIS instruments and rigid endoscopes are susceptible to mechanical
damage.
Systems or components with cavities and channels/ducts must be treated
with particular care to ensure effective cleaning.
Minimum requirements include:

n Removal of all gaskets,
n Opening of all stop cocks,
n Disassembly in accordance with the manufacturer's specifications,
n Rinsing of all cavities.
When immersing such instruments in a cleaning or disinfecting solution,

make sure that the cavities are free of air bubbles so that all the inner
surfaces are completely wetted (to check, agitate the item or hold it at an
angle). Instrument manufacturers may recommend flushing through at a
specified pressure for a defined time.
If instruments with an irrigation connector cannot be taken apart, they

Rinsing forceps with irrigation connection must be sufficiently flushed with a cleaning or disinfectant solution. Make
sure that the distal end of the instrument is adequately flushed as well.
Manufacturers recommend that robotic instruments be cleaned using
enzymatic cleaning solutions. When rinsing, the manufacturer's pressure
and time specifications must be observed.
The glass surfaces of optical systems should be treated by rubbing gently

with a cotton swab saturated with alcohol (use swabs manufactured using
Cleaning the lens of an endoscope
a wooden or alcohol-resistant plastic material).
Instruments with coagulation residues that cannot be removed even

by intensive cleaning (e.g. with hydrogen peroxide solution, brushes or
ultrasound) must be discarded, because their proper function and their
required sterile condition can no longer be guaranteed.
Remove valves and caps from flexible endoscopes prior to processing.

Suitable protective caps must be applied in accordance with manufacturer
specifications. This is the only way to ensure that the channels can be
thoroughly cleaned and flushed. Cleaning is performed by immersing
the flexible endoscope in a bath with a cleaning or cleaner-disinfectant
solution and wiping external surfaces thoroughly.
The channels are first cleaned with the brush supplied with the system,
then rinsed with a cleaning or cleaner-disinfectant solution. Some
manufacturers also offer a hand pump for this purpose. The distal end
(optics, Albarran lever, etc.) must be cleaned with particular care.

Flexible instruments with lockable cavities (e.g. larynx masks with
balloons, or respiration/resuscitation masks) must be cleaned and
disinfected in closed condition to protect the cavities from ingress of
liquids. Rubber and flexible instruments may require a longer final rinse.
Appropriate drying must be carried out to ensure sufficient drying.
6.2 Automated Cleaning and Disinfecting

Cleaning and disinfecting can best be standardized when using machine-
based processes. Always keep in mind that proper cleaning during
instrument reprocessing is essential for retaining the value of your
instruments as well as for successful disinfection and sterilization. The
international standards series (EN ISO 15883), the national versions of
those standards (e.g. DIN EN ISO 15883) and national guidelines state
that only validated machine-based cleaning and disinfecting procedures
should be used. The requirements imposed upon washers and disinfectors
are described in the EN ISO 15883 series of standards.
Automated cleaning and disinfection should ideally be preceded by dry

disposal. When performing wet disposal, either suitable low-foam cleaners
and disinfectants must be used, or the items must first be thoroughly
rinsed. This is because foam significantly impairs the water flow in machine-
based cleaning processes and can affect the result.
This also applies if heavily soiled instruments (problematic encrustations
on HF instruments, filler residues adhering to dental instruments, etc.) have
been pre-treated manually or with an ultrasonic bath.
Ensure correct loading! When using machine-cleaning and disinfection, there are a number of
points that should be observed in particular (see also chapter 6.2.3):
n To ensure effective automated cleaning and disinfection, all trays,
inserts, holders, etc., must be loaded correctly to ensure proper rinsing.
Articulated instruments must be opened for loading.
n Avoid overloading trays to ensure that all instrument surfaces can be
readily accessed by the cleaning/disinfecting solutions. Always consult
the established loading templates for validation purposes.
n When placing large instruments on trays, make sure that they do not
obscure other instruments and create spray shadows, thus preventing
proper cleaning.
n Any instruments with cavities or hollow spaces (such as drives, trocar
sleeves, respiratory systems) need careful cleaning and rinsing on the
inside as well. For this purpose, special (instrument-specific) load carriers
with appropriate rinsing facilities should be used.
n The instruments must be arranged in such a way as to prevent
mechanical damage through contact.

Instruments used for root canal treatment with colored, anodized handles
may fade when using machine-based cleaning processes, potentially
destroying their color-coding function. The use of pH-neutral or mildly
alkaline cleaners and demineralized water for rinsing (also for thermal
disinfection) can improve material compatibility.
The items to be rinsed should be removed from the machine immediately

Visual changes to color anodized aluminum upon completion of the program. If they are left in the self-contained
occurs even in mildly alkaline solutions
machine for a longer period of time, the residual moisture may cause
corrosion.
As a rule, it is advisable to use processes where cleaning is carried out

at a separate stage prior to disinfection. For automated cleaning and
disinfection, both thermal and chemo-thermal disinfection options are
available. As a rule, thermal disinfection is the better choice.
6.2.1 Automated Cleaning and Thermal

Disinfection
In thermal processes, disinfecting is carried out at temperatures above 65°C
for the corresponding exposure time. The A0 value has been introduced as
a measure of disinfectant capability (DIN EN ISO 15883-1*, Appendix A). It
determines the relationship between temperature and time as a function
of microbiological contamination and the intended purpose of the medical
products involved (e.g. A0 3000 = 90 °C and 5 minutes exposure time).
The program structure depends on the outcome requirements for cleaning,
disinfecting, and rinse quality, and on the items to be treated. A machine-
based reprocessing program with thermal disinfection may includes the
following steps or stages, for instance:
Cleaning program with thermal disinfection
1. Pre-wash
Cold water without any additives, to remove coarse dirt and foaming
substances from previous process steps. A second pre-rinsing stage may be
necessary.

2. Cleaning
Hot or cold soft water (ideally fully demineralized); cleaning is usually
carried out at temperatures of 40-60 °C for at least 5 minutes.
Use a suitable cleaning Suitable pH-neutral or alkaline products added to cold to lukewarm water
agent! can be used for cleaning.
The choice of cleaning agents depends on the materials and properties of
the instruments to be treated, the necessary cleaning efficiency, and on
national guidelines and recommendations (e.g. as issued by the Robert
Koch Institute in Germany). Increased chloride concentrations (natural
levels, isotonic solutions) in the water used may cause pitting or stress
corrosion cracking. Such hazards can be avoided by using alkaline cleaning
agents and/or fully demineralized water.
3. First intermediate rinse

Hot or cold soft water (ideally fully demineralized). Adding an acidic
neutralizer facilitates the removal of residual alkaline cleaning agents. Even
when using neutral cleaning agents, it may be advisable to add a neutralizer
if the water is not of ideal quality (e.g. in cases where the water used has a
high salt content), in order to prevent deposits and/or corrosion.
Carry-over of cleaning agent residues due to 4. Second intermediate rinse

insufficient rinsing
Hot or cold soft water (ideally fully demineralized). Depending on the items
to be processed and on the rinsing quality and safety level required, such as
ophthalmic instruments, several intermediate rinses without additives will
take place.
5. Thermal disinfection/Final rinse

Fully demineralized water, thermal disinfection takes place at temperatures
of 80-95 °C and for the corresponding exposure time as per A0-Konzept,
concept, EN ISO 15883.
Using fully demineralized water prevents spotting, stains, deposits and
corrosion on the surfaces of the items to be processed. It also prevents the
formation of crystals which can interfere with the sterilization process.
If you add a final rinse agent to shorten the drying period, make sure to
check the material compatibility of the items to be processed.
6. Drying
Sufficient drying must be ensured either through the washer/disinfector or
by taking other appropriate measures.

Note the specifications With regard to the process chemicals used, the manufacturer's
of the process specifications concerning concentration, temperature and exposure time
chemicals producer should always be observed. This is the only way to guarantee good results
and keep the instrument materials intact to the greatest possible degree. It
must be possible to verify the automatic dosing of process chemicals. For
instruments containing plastics and adhesives, chemical drying aids
(rinsing agents) should only be used in accordance with the instructions of
the manfacturer of the medical product.
6.2.2 Automated Cleaning and

Chemo-thermal Disinfection
Heat-sensitive medical products are treated chemo-thermally. This means
that a disinfectant especially suitable for machine-based disinfection is
used after the cleaning stage. The temperature must be limited in all rinsing
phases as well as during drying.
In chemo-thermal processes (as per EN ISO 15883), cleaning is carried out

at defined temperatures (normally < 65 °C, for flexible endoscopes < 60 °C),
and for disinfection, a disinfectant suited to the machine is added for the
appropriate concentration and specified exposure times.
Example of a cleaning program with chemo-thermal disinfection:
Cleaning program with chemo-thermal disinfection for heat-sensitive endoscopes
1. Pre-wash
Cold water without any additives, to remove coarse dirt and foaming
substances (such as residues from pre-treatment).
2. Cleaning
Hot or cold soft water (ideally fully demineralized); cleaning is usually
carried out at temperatures of 40-60 °C for at least 5 minutes.
Suitable neutral-pH or alkaline products can be used as cleaning agents.
The choice of cleaning agent depends on the materials and properties of
the instruments to be treated and on the required cleaning efficiency.

3. Intermediate rinse
Hot or cold soft water (ideally fully demineralized).
4. Chemo-thermal disinfection
Hot or cold soft water (ideally fully demineralized). A special disinfectant
with proven effectiveness and suitable for machine-disinfection is used.
Chemo-thermal disinfection is performed under the conditions specified
by the producer of the process chemicals (concentration, temperature,
time).
5. Intermediate rinse
Hot or cold soft water (ideally fully demineralized water) with no
additive (if appropriate, additional intermediate rinses to ensure that the
disinfectant has been sufficiently rinsed away to ensure non-toxicity).
6. Final rinse
Fully demineralized water, final rinsing at higher temperature, at less than
60 °C for endoscopes. The use of demineralized water prevents spotting,
deposits and corrosion on the surfaces of the items to be rinsed. For
instruments containing plastics and adhesives, chemical drying aids
(rinsing agents) should only be used in accordance with the instructions of
the manfacturer of the medical product.
7. Drying
Sufficient drying must be ensured either through the washer/disinfector or
by taking other appropriate measures. The drying temperature should be
set to suit the temperature stability of the items to be processed
(e.g. for heat-sensitive endoscopes < 60 °C).
Note the manufacturer's With regard to the process chemicals used, the manufacturer's instructions
specifications concerning concentration, temperature and exposure time should always
be observed. This guarantees good results and keeps the instrument
materials intact to the greatest possible degree. It must be possible to verify
the automatic dosing of liquid process chemicals.
6.2.3 Instrument Groups Requiring Special

Treatment
Microfilters used in the load carrier to protect medical products with fine
channels, complex structures or sensitive drives must be regularly cleaned
or replaced in a controlled fashion in accordance with manufacturer
specifications.

Microsurgical instruments can be reprocessed and disinfected using
machinery in the same manner as other surgical instruments, provided the
instruments are safely held in place (e.g. by using racks) and the rinsing
method is adapted accordingly.
Ophthalmic instruments: With these instruments, it may be necessary to

measure the pH value, to check that the instruments are clear and possibly
to manually dry them after cleaning and disinfection, if the result of drying
is not satisfactory after machine-based reprocessing.
Dental instruments can also be machine-cleaned and disinfected in the

same way as surgical instruments. However, the following specific points
need to be observed:
n Probes and other sensitive instruments must be placed on special

holding devices for protection.
n Instruments with rotating components such as drill bits, cutters, burrs
or abrasive tools are only suitable to a limited degree for machine-
cleaning and reprocessing. It may be necessary to carry out an additional
pre-treatment by ultrasound.
n Instruments for root-canal treatment may only be machine-treated if
each item is held in place securely and safely by appropriate supports.
Otherwise, ultrasonic bath treatment is preferable.
n Handpieces and elbows can be machine-cleaned and disinfected
where permitted by the manufacturer, and if special rinsing fixtures are
available for rinsing the turbine drive's spray, air channel or air infeed
& recirculation system. The instruments must be removed from the
washer/disinfector immediately after the process is complete. It may be
necessary to dry them again once removed from the washer/disinfector.
n Mouth mirrors are subject to wear. Silver-backed glass mirrors may
become dull as a result of machine-cleaning and disinfection; rhodium-
plated mirrors are more resistant, on the other hand. but are easily
damaged by mechanical impact.
Motor systems may only be machine-cleaned and disinfected if the

manufacturer allows such treatment using such substances and machinery.
Reusable tools approved for use in surgical applications can be machine-
cleaned and disinfected in the same way as surgical instruments, although
most require additional pre-treatment in an ultrasonic bath.
MIS instruments, rigid endoscopes and HF instruments must be

disassembled for machine-cleaning and disinfection in accordance with
the manufacturer's specifications. All seals/gaskets must be removed and
Ensure internal rinse! all stop cocks opened or removed as appropriate. Such parts may only be
machine-cleaned and disinfected if approved by the manufacturer. To avoid
damage, fix the items securely in place. The machine and loading trays used

must have appropriate facilities that allow sufficient and reliable internal
rinsing in the case of hollow instruments as well.
Discard! Instruments with stubborn coagulation residues that cannot be removed

by additional intensive cleaning (e.g. hydrogen peroxide solution, with
a brush or ultrasound) must be discarded as their proper function and
sterility can no longer be guaranteed.
Robotic instruments Robotic instruments cannot be dismantled – or can be dismantled only to a

limited extent – so special recommendations for their reprocessing need to
be followed. Proper preparation for machine-based cleaning and disinfection
must be ensured in particular. To achieve perfect cleaning and rinsing results,
fully demineralized water needs to be used in all process stages.
Flexible endoscopes can only be machine-cleaned and disinfected in

special washers/disinfectors. If endoscopes are pretreated manually prior
to machine-based reprocessing and disinfection, all cleaning agents and
disinfectants used must be compatible with each other. This prevents poor
results as well as endoscope surface changes and excessive foaming inside
the machine.
Prior to machine-cleaning and disinfection, a leak test must be carried out

in accordance with the manufacturer's specifications. This ensures the early
detection of leaks and perforations in order to avoid subsequent damage
caused by penetrating liquids. Some washers/disinfectors can carry out
a leak test automatically, either before the program starts, or while it is
running. Defective endoscopes must be returned to the manufacturer,
together with a description of the problem (see chapter 4).
Manual leak test on flexible endoscope
Alkaline process chemicals may damage endoscopes, so it is important

to use only special cleaners and disinfectants suitable for the machine-
based reprocessing of flexible endoscopes. Throughout the cleaning
and disinfecting cycles the maximum temperature of 60°C may never
be exceeded. Moreover, the instructions provided by the endoscope
manufacturer must always be carefully observed.
During automated cleaning and disinfection, the endoscope must be

securely kept in place inside the machine. Use appropriate devices to
ensure that all external surfaces as well as the inside of all channels/ducts
are thoroughly and reliably cleaned and flushed.
Suitable technical measures must be taken to ensure that the water used
for the final rinse is treated in such a way that prevents renewed microbial
development on disinfected endoscopes.
Prior to storing endoscopes for later use, proper drying is necessary to
prevent the development of microorganisms. This can be done either in
the washer/disinfector or in a suitable storage cabinet with controlled

environmental conditions for reprocessed, heat-sensitive endoscopes
(in accordance with DIN EN 16442).
Flexible instruments with sealable cavities (such as tubes with balloons,

respiration/resuscitation masks, etc.) must be cleaned and disinfected while
sealed so that no liquid enters the cavities. To prevent the mask bulge
from being overstretched, discharge some of the air prior to reprocessing
(remove the plug, squeeze out some air, then replace the plug).
It is necessary to be extra careful when processing rubber instruments,

because cleaning agent or disinfectant residues can cause irreversible
damage during subsequent drying or sterilization. This is due to the fact
that such residues may damage the surface of the material and so cause it
to become sticky. Latex coatings tend to blister off.
Ensure complete drying! Residues adhering to functional parts of respiratory systems are
particularly problematic. It is also vital that all such parts are completely
dried, as even very small amounts of moisture may cause malfunctions.
Functional parts of respiration systems of anesthesia machines have
been specifically designed by the manufacturer, and therefore must be
processed in accordance with the manufacturer's instructions.
Flexible heat-sensitive instruments (e.g. PVC products) must never be

processed (disinfected, cleaned or dried) at temperatures above 60°C.
Flexible instruments such as rubber/latex instruments made from
natural rubber, may not be dried at temperatures above 95°C, as higher
temperatures would greatly reduce their useful lives. The recommended
temperature range for drying here is 70-80 °C.
6.3 Ultrasonic Cleaning and Disinfecting

Ultrasonic treatment is a very good choice to help with cleaning
instruments made of stainless steel or hard plastic materials (except
elastomers). Instruments sensitive to mechanical impact (e.g. microsurgical
or dental instruments) can in particular be conservatively and thoroughly
cleaned and disinfected in one operation with the help of ultrasound.
Powerful ultrasonic devices are able to dissolve encrustations in places
that are difficult to access otherwise.
Ultrasonic cleaning is used:

n as an effective mechanical method supporting manual cleaning
processes.
n to remove stubborn residues.
n as an integral part of machine-based reprocessing treatments, thus
supporting other measures for improved cleaning results.
Ultrasound unit installed in work area

To secure optimal cleaning results when using ultrasound, observe the
following:
n Fill the bath in accordance with the manufacturer's instructions.
n Add a suitable cleaning agent or a combined cleaner-disinfectant.
n When using both disinfectant and cleaning agents, the concentration,
temperature and ultrasound treatment/exposure time must be chosen in
accordance with the manufacturer's instructions to ensure compatibility.
n We recommend filling the bath with water at room temperature.
n Water temperatures above 45°C can lead to encrustations due to protein
denaturation.
n Freshly prepared disinfectant or cleaning solutions require degassing
before their first use.
n The efficacy of the ultrasonic bath can be verified by the foil test to
IEC/TR 60886: 1987. Upon completion of the test, the ultrasonic bath
should be thoroughly rinsed in order to prevent dissolved aluminum
particles from being deposited on instruments.
Apart from a properly prepared bath, the following basic rules should
always be observed to ensure good cleaning results:
n The items to be treated must be fully immersed in the liquid.
n Articulated instruments, scissors etc. must be opened in order to
minimize the obscured surface areas. Insert instruments next to each
other; do not stack them.
n Use only suitable trays (e.g. wire or perforated plate trays) that do not
obstruct the ultrasonic cleaning process.
n Large-surface, bulky instruments must be placed so that they do not
create acoustic shadows. Such items should be placed vertically.
n Do not overload trays.
n Ultrasonic baths should be refilled each day. Disinfectant solutions
can have long lives provided they are duly certified, taking care to
observe national guidelines as well as manufacturer specifications.
As high contamination levels impair ultrasonic cleaning and promote
corrosion, more frequent replacement of the ultrasound solution may be
necessary, depending on the requirements of specific cases.
n Given powerful equipment, ultrasonic treatment times of approx.
3 minutes at frequencies of around 35 kHz should be sufficient.
n If disinfection and cleaning are carried out simultaneously, make sure to
use suitable products, paying attention to concentration and exposure
time requirements.
If shorter exposure times and/or lower concentrations for disinfection

are recommended than without ultrasound, such values must always
be checked and corroborated by microbiological examinations (expert
opinions), taking into account temperature, frequency range and germ
spectrum, and also monitored in the course of practical application.

Following ultrasonic treatment, the instruments must be thoroughly rinsed
manually. The manual final rinse can be carried out with fresh tap water,
taking care that all cleaning agent and disinfectant residues are completely
removed in the process. To avoid water spots, we recommend using fully
demineralized water for the final rinse.
Microsurgical instruments must be stored on special holders in order to

prevent damage.
Acidic cement removers and basic cleaners should be used in accordance

with manufacturers' specifications in the ultrasonic bath. The bath
container must be material-compatible.
Handpieces, elbows and turbines should never be treated in an ultrasonic

bath. With the exception of simple tools and accessories, motor systems
should never be treated in an ultrasonic bath.
Due to the materials used in their construction, dental instruments with

rotating components must often be treated with special disinfectants and
cleaning agents. Prior to ultrasound treatment, they should be placed in
special stands to avoid any contact damage between the instruments
(e.g. via sharp cutting edges, diamond grains). After a quick rinse under
running water followed by immediate drying, dental instruments with
rotating components must be treated with a sterilization-stable anticorrosive
agent. Polishing and flexible instruments cannot be processed in the
ultrasonic bath, because the flexibility absorbs the ultrasound.
Mouth mirrors may be damaged by ultrasonic bath treatment.
MIS instruments, robotic instruments, endoscope accessories and

HF instruments which are suitable according to the manufacturer's
specifications may be treated in an ultrasonic bath. The rinsing and
agitation of special instrument components during ultrasonic exposure
supports the cleaning effect.
Camera systems and optical cables may never be cleaned in an ultrasonic

bath.
Flexible endoscopes must never be processed in an ultrasonic bath.

However their accessories (such as valves, caps, biting rings or forceps) can
be treated in this way.
Elastic instruments do not respond well to ultrasonic processing, as
ultrasonic waves have only a limited effect on them.
Functional parts of respiratory systems may not be processed in an

ultrasonic bath.

7. Final Disinfection
A final disinfection is carried out for instruments that cannot be sterilized
or where sterilization is not required. In most cases, this applies to heat-
sensitive instruments such as flexible endoscopes or equipment used
in anesthetics. In many regions, this step is referred to as "high-level
disinfection" (HLD).
Agents must be used in this disinfection step that have at least proven
bactericidal, mycobactericidal, fungicidal, and virucidal effects. National
regulations may require difficult ranges of effects.
Final disinfection can be performed either manually or using a machine

at room temperature, or using a machine at higher temperatures with
a chemo-thermal or thermal process. For machine-based thermal and
chemo-thermal disinfecting processes with integrated cleaning stage,
refer to section 6.2.
For final chemical disinfection, aldehyde and peroxide compounds are
primarily used as microbicidal agents. The disinfection effect of the
disinfectant should have been proven under "clean conditions"
(no contamination) in accordance with EN 14885 or equivalent national
guidelines.
Observe material Material compatibility depends on the instrument material, the composition
compatibility! of the disinfectant, the temperature, the exposure time, the concentration,
and the pH-value of the solution being used (see also chapter 2.2).
If the same products are used for disinfection & cleaning as for final
disinfection, separate solutions must be used for the two steps. If products
based on different agents are used, product compatibility must be ensured
(to prevent the formation of deposits, for example).
Ensure complete wetting! In the final chemical disinfection, it is important to ensure that all surfaces
to be disinfected are completely covered by the solution, including the
gaps in articulated instruments, and any channels or cavities.
We recommend using disinfecting solutions for no longer than one

day. Some producers claim longer usage times, in which case the agent
concentration should be checked regularly (at least daily), because losses
can occur either during the introduction and removal of instruments, or
due to chemical reactions.

Flexible endoscopes are sufficiently rinsed externally as well as internally
with water in accordance with the cleaning instructions given in
chapter 6.1, and are then immersed in a disinfecting solution. It is
important to ensure that the endoscope is completely covered by the
disinfectant solution and that all channels are completely filled or wetted
by the solution flowing through them.
In the case of flexible endoscopes, this can be done with a hand pump
or by using a program-controlled automatic pump system. Make sure
to disinfect the discharge ducts as well! Following chemical disinfection,
external surfaces and all channels of the endoscope must be thoroughly
rinsed to remove any residues. To avoid water spots, use only fully
demineralized water. To prevent recontamination, sterile or low-germ
water should be used.
To dry the external surfaces of flexible endoscopes, use a virtually lint-
free cloth. The channels should be dried with a hand or suction pump or
with compressed air at max. 0.5 bar, depending on the manufacturer's
specifications. The use of oil-free, low-germ compressed air prevents
unwelcome recontamination.
In the case of flexible instruments made of plastic or rubber, white spots

are caused by the penetration of water into the instrument's surface. Such
spots can only be removed by drying.
To prevent diaphragm damage in functional parts of respiration systems,
do not use compressed air for drying.
8. Checks and Care

Cleanness Sufficient cleaning standards are absolutely vital for successful
sterilization. Instruments to be sterilized must be checked visually
and by touch, and must be macroscopically clean, i.e. free from visible
residues. This is checked by visual inspection. Critical areas such as handle
structures, joints or jaw serration (particularly atraumatic toothing) require
especially careful checking.
It is advisable to use working lights, such as light magnifying glasses

with lenses of 3 diopters when checking the fine tips of instruments. If
there is any doubt as to the level of cleanliness, particularly in the case of
instruments with cavities, chemical tests for protein and blood must be
carried out, for instance with 1% sodium dodecyl sulfate solution (pH 11)
after intensive elution/extraction.
All instruments with lumens, such as cannulas, etc., must be checked for
blockages, for instance with a suitable cleaning brush. Clogged instruments
must be reprocessed. If this does not help, such instruments must be replaced.

Poorly cleaned instruments must be recleaned (as described below) and
then rinsed sufficiently:
n Manual cleaning, if necessary with ultrasound (see chapter 6).
n Immersion in a 3% H2O2 solution (for approx. 5 minutes; note
exceptions!)
Integrity To prevent damage and secondary corrosion due to metal abrasion, never
use metal brushes or metal sponges to remove stains.
Surface changes Instruments with hairline cracks in the joint areas, as well those that are
damaged, distorted or otherwise worn, must be replaced because their
function can no longer be fully or adequately guaranteed.
Instruments with corrosion residues or damaged nickel-chromium coating

need special treatment. Such treatment is not mandatory, however, in the
case of discolorations and/or stains.
For detailed information and recommendations on this topic, please refer to
chapter 12.
Stress cracks next to scissor hinge
Care Maintenance and care measures are usually carried out prior to the function
check.
Maintenance or care means targeted application of instrument milk to

the joints, hinges, locks, threads or friction surfaces of instruments such
as clamps, scissors or punches, after they have been carefully cleaned and
disinfected.
This prevents metal-on-metal friction and therefore constitutes a preventive
measure against friction corrosion. In this way, the instruments are kept
functional and hinge action maintained.
Requirements imposed upon care agents for surgical instruments:

n Paraffin/white oil based, in accordance with the current European or
United States Pharmacopeia,
n Biocompatible,
n Suitable for steam sterilization and vapor-permeable.
Instruments must not be treated with care agents containing silicone oil.
This can adversely affect the instrument's functionality and also the results of
steam sterilization.
Proper performance of care measures:

Allow the instruments to cool down to room temperature before opening
and closing the instruments, as otherwise metal abrasion might occur
Targeted joint cleaning when the parts rub against each other. Such "fretting" would impair the
instrument's ease of movement or even destroy its functionality altogether.

The care agent must be applied manually and accurately to joints, threads
and friction surfaces. This applies in particular to articulated instruments
treated in special cleaning procedures using a hydrogen peroxide additive.
The care agent must be distributed evenly by operating the joints/friction
surfaces. Any excess care agent must be removed from the surface with a
lint-free cloth.
Corrosion due to insufficient use of care products Spraying the instruments or applying the care agent mechanically is not
sufficient, nor does it provide additional corrosion protection.
Never process plastic surfaces with instrument care agents.
Function As surgical instruments are made for specific application purposes, the
functional tests must be carried out so that items that fail to serve their
intended purpose are reliably recognized and discarded. If in doubt,
consult the instrument manufacturer for suitable testing methods.
Articulated and threaded instruments must be lubricated before

subjecting them to a functional test using a squirt oiler, an oil pen, or
through targeted application of drops of oil.
The proper functioning of the instruments must be assured by testing.

Such a test must always be carried out on the fully assembled instrument.
The item should be taken apart again for sterilization after successful
testing as necessary. Make sure you proceed in accordance with the
manufacturer's instructions when assembling and disassembling the
instrument.
For medical products submitted for repair, please note the information in
chapter 4.
After the check, microsurgical instruments must be stored in the special

racks designed for them that prevent transportation damage. If indicated,
suitable facilities should be employed to secure them against dislocation.
Care Dental instruments are usually serviced in the same manner as surgical
instruments. However, there are some exceptions:
n A few dental instruments with rotating components (drill bits, cutters,

burrs, reamers) must be treated with an anti-corrosion agent which
is suitable for use with sterilizing media such as steam or hot air,
immediately after drying.
n Handpieces, elbows and turbines must be treated with special agents
in accordance with the manufacturer's instructions due to their
complicated internal design.

Care As proper lubrication and care is a vital factor for long-term value
retention in the case of motor systems, the manufacturer's instructions
should be carefully followed. Motors and handpieces may be engineered
to be sealed or not sealed. In the latter case, a care spray must be applied
after each reprocessing.
Compressed air motors must be lubricated using a special care spray

or oil (the motor may need to be run afterwards, see manufacturer
specifications).
This excludes maintenance-free compressed air motors, labeled
accordingly. As a rule, all movable external parts, such as pushbuttons or
tool couplings, should be properly lubricated, unless expressly forbidden
by the manufacturer. Make sure to use only lubricants approved by the
manufacturer.
Function Before sterilization, surgical motors and their accessories must be subjected
to a function test in accordance with the manufacturer's instructions. All
compressed air components must also be subjected to a leak test and be
visually inspected for potential defects, especially the compressed air hoses
and motors.
To check the air intake duct, it is necessary to connect the air hose to the
compressed air connector. Leaks can then be detected either acoustically or
by submerging the hose in water.
To check the air discharge duct, the compressed air motor must also be
connected to the compressed air hose. After starting the motor, leaks can
best be detected by submerging the hose in water.
Simple tools must be checked in accordance with the instructions for

general surgical instruments. To prevent transportation damage, tools
should be stored in special fixtures and secured against slipping.
Cleanness Residues on endoscope glass surfaces, optical fiber cables and camera
heads can be removed with a swab soaked in alcohol.
For this purpose swabs made of wood or alcohol-resistant plastic should
be used. Swabs including metal should be avoided as they may scratch
glass surfaces. Note also that alcohol is not suitable for removing blood
residues.
Glass surfaces with stubborn deposits (e.g. in the case of oculars, lenses
or light connectors) can be treated with a cleaning agent or cleaning
procedure recommended by the manufacturer.
If deposits or tarnish cannot be removed in this way, the instrument must
be sent back to the manufacturer for inspection.

Integrity Worn parts, defective components, gaskets and sealing rings must be
checked for integrity before each sterilization cycle. If damaged, they must
be replaced.
Damaged, blunt and/or distorted cannulas must be taken out and
discarded.
Instruments with damaged insulation must be replaced immediately

because they would pose a risk to patients, users and third parties.
Optical fiber cables and endoscopes must be checked for fiber breakage
by holding the distal end against a light source and looking into the cable
at the other end (the connector side of optic). Fiber breakage is indicated
by black spots in the waveguide. If more than about 30% of the fibers are
Damaged insulation on HF instrument broken, the light output at the distal end is no longer adequate. If this is
the case, the cables or endoscopes must be returned to the manufacturer
for repair. Check endoscope cover glasses for relevant scratch marks and/
or cracks. These can result in leaks, causing the optical mechanism to fail.
Care Care agents should not be applied manually or automatically to optical

systems, gaskets or current-carrying components, because this could
cause significant problems and lead to loss of function.
Joints, threads and friction surfaces, as well as connections subject to

regular servicing on rigid endoscopes must be treated with instrument oil
in accordance with the manufacturer's instructions. Alternatively, a special-
purpose grease can be used if permitted by the manufacturer.
Function A function test ensures the proper functioning of MIS instruments and
rigid endoscopes. Such a test must always be carried out on the fully
assembled instrument. The item must subsequently be taken apart again
if sterilization is necessary. Make sure you proceed in accordance with
the manufacturer's instructions when assembling and disassembling the
instrument.
Cleanness Glass surfaces of flexible endoscopes (lenses, oculars and light entry/exit
surfaces) must be checked for cleanliness in the same way as for rigid
endoscopes.
Respiratory systems must be checked in accordance with the

manufacturer's specifications to ensure that they are undamaged and
functioning properly. (The channels must be checked for blockages
during or before machine-based reprocessing and immediately before
procedures).

Integrity Gaskets, sealing rings, valves, caps and other parts which wear out, must
be checked for integrity after each reprocessing cycle. If damaged or worn,
they must be replaced.
Endoscopes with damaged feed and/or elbow tubing, or other defects,
must be taken out and sent for repair.
Care In the case of flexible endoscopes, always check whether the valves
(if incorporated) need treating with an care agent recommended by the
manufacturer before use.
Note that the endoscope surface must not be sprayed because spray
propellants damage these instruments. Vaseline, silicone oil or care agents
containing paraffin cause swelling or softening in plastic components
(see also chapter "Surface Changes"!).
Swelling at distal end of fiberscope Only suitable grease-free gels may be used as lubricants in accordance
with the manufacturer's specifications.
Function Immediately after an endoscopic procedure, all functions of the
instrument must be checked or tested in accordance with the
manufacturer's specifications.
Respiration systems must be checked in accordance with the

manufacturer's instructions, to ensure that they are in proper working
order, and are functioning properly.
Flexible instruments must be checked for proper functioning in

accordance with their intended purpose. The most important checks and
tests include:
n Checking the integrity of balloons.
n Checking balloon filling systems for leaks.
n Checking instrument lumens for obstructions.
n Testing connectors for functional safety.
n Inspecting tracheal tubes for distortion, e.g. radii.
n Checking polysulphone connectors and similar products for stress
cracks.
Integrity Make sure to remove and discard any damaged or defective instruments!
Frequent damage includes:
n Blistering,
n Surface cracks (e.g. ozone cracks; crazing/orange-peel effect, i.e.
network of directionless micro-cracks); stress cracks in plastic
components,
n Sticky surfaces,
n Hardening,
n Porous surfaces.

Care Flexible instruments and respiration systems must never be treated with
lubricants or care agents before sterilization. Where required, special
servicing and care measures are always indicated by the manufacturer.
Never use silicone oil! Flexible instruments made of silicone rubber must not be treated with
silicone oil because it may cause swelling, thus destroying the instrument's
functionality. To prevent swelling in rubber and latex instruments, never
use agents containing paraffin.
Repair Damaged medical products, or products that are no longer functioning

properly must be sent for repair or scrapped.
Maintenance Always send medical products to the manufacturer for servicing as per the
maintenance schedule.
9. Packaging
International standard EN ISO 11607 Parts 1 and 2 apply to packed items
requiring sterilization. The standard stipulates the packaging material
(Part 1) and the validation of the packaging process (Part 2).
Sterile barrier system The packaging for items for sterilization must be of a type representing a
sterile barrier system. Its task is to prevent micro-organisms from entering
the packaging and to enable removal under aseptic conditions. It must
also be possible to open the package easily under aseptic conditions.
The sterile barrier system is a microbial barrier which prevents
recontamination under specified conditions. Such conditions include:
n temperature
n pressure
n humidity
n sunlight
n cleanness
Sterile items container n microbial contamination.
Protective packaging The protective packaging is an additional package designed to prevent

damage to the sterile barrier system from the moment it is put together
until the moment of use.
Packaging types The sterile barrier system can be a reusable system (sterilising container)
or a disposal product (non-woven fabric, paper, transparent bag).
Containers and storage systems help to retain the value of instruments.
The packaging has a considerable effect on sterilization results. Therefore,

the packaging system (sterile barrier system and protective packaging)
must be compatible with the sterilization procedure. The packaging

material must not absorb the sterilizing agent beyond a reasonable limit,
and must not cause any alterations in the sterilizing agent. The suitability
of the packaging, including its sealing and composition, is verified in the
course of validating the sterilization process.
Whenever new materials are used that have not yet been properly
validated, the performance assessment (validation) must be repeated.
Drying To retain the value of the instruments, it is also important that they are
sufficiently dried, because residual humidity can cause corrosion damage.
If non-woven fabric is used, care should be taken to ensure that it does not
interfere with the drying process.
Marking It must be possible to mark and identify the package with information
such as:
n Sterilization date,
n Packer,
n Expiry or "use before" date (if date has been defined),
n Contents.
10. Sterilization
Within the scope of European (EN) standards, the application of sterile
instruments on or in the patient requires proper cleaning and disinfecting,
followed by sterilization in approved packaging, on the basis of a validated
sterilization process. Following such treatment, the sterile items must
be stored in accordance with the rules and provisions governing sterile
supplies. Consequently, it is important for the specific instruments group
that only use sterilization methods and sterilizers be used that allow
validated sterilization processes. During validation, it must be confirmed
that the sterilization method used in the reprocessor is suitable for the
products to be sterilized and that the results are reproducible.
Sterilization accessories and packaging materials must be selected in line

with the items to be sterilized as well as with the sterilization method
being used.
In this context, the user instructions for the sterilizer used must be strictly
observed.
For thermostable products, steam sterilization is the method of choice!

10.1 Steam Sterilization
Steam sterilization is performed with saturated steam, usually at
134 / 132 °C.
Stain formation due to If chemoindicators are used in large numbers in a sterilization batch, it
"running" chemoindicators may lead to stains on instrument surfaces, especially if there is direct
contact between instruments. This particularly applies to silver products or
products with silver-plated surfaces.
If validated steam sterilization processes are used in accordance with

ISO 17665 (or DIN 58946 Part 7 in Germany) and all process-related
parameters such as pressure, temperature and the proportion of non-
condensible gases in steam are documented, it is possible to forgo
chemoindicators or bioindicators for batch control, provided that the three
parameters relevant to the procedure are consistently monitored.
Ensure steam quality in The sterilization steam used must be free of impurities and should not
accordance with EN 285! impair the sterilization process, nor should it damage the sterilizer or the
items to be sterilized. To ensure this, the tolerances specified in
EN 285, Table B.1, relating to the quality of the boiler feed water and the
condensate may not be exceeded. Otherwise corrosion may result from
contaminants, such as rust particles in the piping system, or discoloration
caused by excessive silicic acid levels may appear on instrument surfaces.
Contamination in the condensate of a steam supply for sterilizers, measured at the sterilizer
supply line
Substance/Property Condensate
Marbling caused by impurities in steam
condensate Silicates (SiO2) ≤ 0.1 mg/l
Iron ≤ 0.1 mg/l
Cadmium ≤ 0.005 mg/l
Lead ≤ 0.05 mg/l
Heavy metal residues, except for iron, cadmium, lead ≤ 0.1 mg/l
Chlorides (Cl-) ≤ 0.1 mg/l
Phosphates (P2O5) ≤ 0.1 mg/l
Conductivity (at 20 °C) ≤ 4.3 µS/cm
pH value (degree of acidity) 5 to 7
Source: EN 285: 2015, Table 4
Appearance colorless, clear,
no deposits
Note: A method for extracting a condensation
sample is specified in chapter 21.4. Hardness (Σ of alkaline earth metal ions) ≤ 0.02 mmol/l
If the feed water contains large quantities of bicarbonate hardness,

it increases the inert gas content of the sterilization steam and may
adversely affect the sterilization result.
Corrosion hazards due Damp or wet containers pose instrument corrosion hazards. Poor and
to residual humidity/ insufficient drying is frequently caused by the improper arrangement
dampness! of loads, the use of less suitable types of non-woven fabrics for drying,
and plastic dishes for instrument sets. In principal, heavy sieves should
be placed at the lowest level, so that the majority of the accumulated
condensate can drain off directly. Special drying measures must be

adopted when validating items weighing more than 10 kg per sterilizing
unit (30x30x60cm). In practice, residual moisture in the form of a few
drops of water capable of evaporating within 15 minutes is tolerated, but
actual pools of water are not acceptable! Even so, a few drops of water
may cause some spotting.
To prevent residual moisture altogether, consult the manufacturer of your
sterilizer for relevant procedures.
Dental instruments can usually be steam-sterilized in the same way as

surgical instruments. Should separate treatment be required for dental
instruments, the following instructions apply for steam sterilization:
n Dental instruments with rotating components (e.g. drill bits or burrs)
are steam-sterilizable.
n Handpieces and elbows should be sterilized at 134 / 132 °C wherever
possible to keep treatment time to a minimum.
n In the case of drive systems, consult the manufacturer's instructions to
determine whether or not steam sterilization is permitted.
n Mouth mirrors can be steam-sterilized, but being subject to wear, will
soon become dull as a result of the ingress of moisture. This is possible
because of the different thermal expansion coefficients of different
materials.
Any motor systems used under sterile conditions can be steam-sterilized

at 134 / 132°C.
Make sure the manufacturer's specifications are observed (e.g. regarding
securing) during sterilization.
Kinking reduces service Compressed air hoses need to be protected against mechanical damage
life and impairs the (such as compression or kinking) during sterilization. They must be
functionality. positioned in the sterilization trays so that the permitted bending radii is
observed and condensation can run off.
As regards battery-powered systems, make sure to strictly observe the

manufacturer's instructions for sterilizing batteries.
MIS instruments, rigid endoscopes, optical fiber cables and HF instruments

can usually be sterilized in the same manner as surgical instruments.
Steam-sterilizable optical systems should be sterilized at 134 / 132 °C rather
than at 121 °C, due to the shorter exposure time (and correspondingly
lower thermal stress). Alternatively, a suitable low-temperature sterilization
process can be used to completely avoid thermal stress. To avoid
mechanical damage, optical systems should always be stored securely in
accordance with the manufacturer's instructions during sterilization.

Flexible endoscopes are not steam-sterilizable due to their limited heat
stability. A low-temperature sterilization process must therefore be used
for these in cases where sterilization is required. However, all items used
endoscopically (such as forceps, catheters, etc.) must be steam-sterilized.
Flexible instruments made of silicone elastomer or natural rubber or latex,

with and without a balloon, can be steam-sterilized. Due to the lower
thermal stress tolerance, it is preferable to sterilize them at 134 / 132 °C.
Items made of temperature-sensitive materials (e.g. plastics) are only steam-
sterilizable if they are marked as such, or if such treatment is expressly
permitted by the manufacturer.
When steam-sterilizing flexible instruments, all cavities e.g. bulge of mask,
balloon, must remain open during sterilization, to prevent damage caused
by pressure variations.
Cavities locked with a valve must be completely emptied i.e. made water-
and air-free, with a syringe before sterilization.
Functional parts of respiratory systems can be steam-sterilized at

134 / 132 °C. Cavities must remain open to prevent valve damage.
10.2 Hot-Air Sterilization

Although hot air sterilization no longer represents the state of the art, it is
still being used in isolated cases. If sterilization is still carried out with a hot
air sterilizer, the following instructions continue to be effective and must
be observed:
At temperatures above 185 °C, paraffin oil will resinify. This destroys its
lubricating properties and thus impairs the instrument's function.
Prescribed temperature If the specified temperature is significantly exceeded, there is a corrosion

should not be exceeded! hazard as well as the risk of loss of hardness. Consequently, functionality
is compromised, making instruments useless in many cases. Similarly,
plastics such as color rings may be adversely affected or even destroyed at
higher temperatures.
To ensure uniform heat distribution in the sterilization chamber, and

thus in the items to be treated, the sterilizer loading instructions must
be strictly observed! MIS instruments and endoscopes must never be
sterilized with hot air.

10.3 Low-Temperature Sterilization
Low-temperature sterilization methods include gas sterilization and gas
(plasma) sterilization. All these procedures work with chemical agents at
temperatures between 37 and 75 °C.
When choosing the low-temperature sterilization procedure, please

take particular notice of the reprocessing instructions specified by the
manufacturer of the medical product.
It is possible that the concentrations of agents will differ depending on the

type, procedure and year of manufacture of the sterilizers used, and errors
would cause various amounts of damage to the processed products.
Due to the possibility of harmful interactions, a medical product should

always be sterilized in a low-temperature sterilization process!
Depending on the sterilization procedure different kinds of packaging

are permitted. In general, containers used for steam sterilization are not
suitable.
For environmental reasons and in the interest of patient and personnel

safety, low-temperature sterilization methods should only be used for
items that cannot be steam-sterilized!
Items sterilized with ethylene oxide require adequate aeration following

sterilization (and before reuse). Aeration times may vary considerably,
depending on ventilation conditions and the product treated. For reliable
aeration times, always consult the instrument manufacturer and/or
observe the corresponding instructions.
Sterilization with EO gas may only be used for motor systems if expressly
specified by the manufacturer.
Rigid optical systems that cannot be steam-sterilized are sterilized at low

temperatures in accordance with the manufacturer's specifications.
Flexible endoscopes can be sterilized up to a maximum temperature

of 60°C, using a sterilization method permitted by the manufacturer.
For sterilization the flexible endoscope must be packed in a transparent

tube, in the extended condition wherever possible. Make sure the aeration
cap is placed on the inlet connector, otherwise the instrument could be
irreversibly damaged.
To ensure protection against mechanical damage, the sealed-in flexible

endoscope must be held securely on the sterilizer tray. Make sure that the
loop diameter is no less than 30 cm.

Following sterilization and adequate aeration (if required), flexible
endoscopes must always be stored in their extended state to avoid
deformation and kinks.
Flexible instruments made of heat-sensitive plastic are not steam-sterilizable,

but are sterilized using one of the methods indicated by the manufacturer.
Cavities locked with a valve must be fully evacuated and all water
removed with a syringe prior to sterilization.
Flexible instruments made of rubber, as well as functional parts of

respiration systems, should not be gas-sterilized, as they can more
effectively be steam-sterilized.
When sterilizing medical products incorporating a battery (such as cardiac

pacemakers or implantable defibrillators), please note that the battery
charge may be reduced during the process, depending on temperature
and treatment time.
11. Storage
11.1 Storing Non-Sterile Instruments
Instruments stored in poor conditions can corrode. To prevent this they
should be stored in dry and dust-free conditions. Major temperature
fluctuations should be avoided to prevent the accumulation of moisture
(condensate) on instrument surfaces.
Chemicals may destroy metals when in direct contact with them, or may
emit corrosive vapors. Never store your instruments near chemicals.
The storage of instruments must be organized in such a way that they

cannot damage one another. Appropriate systems must be used to ensure
this; such systems improve overall clarity of the organization, while also
reducing the risk of injury to users.
Closed storage systems are preferable in order to ensure additional

protection against pathogens.
Flexible endoscopes that are used in a disinfected state should ideally

be stored in a designated storage cabinet with controlled environmental
conditions in accordance with EN 16442. They should be stored in a
hanging position in sterile, dry, low-dust and well-ventilated conditions.
Endoscopes must be sufficiently dry before storage. Valves and caps must
be removed and stored separately, under dry and dust-free conditions.
Flexible endoscopes must not be stored in transportation cases.

To prevent premature failure of flexible instruments, avoid kinking or
overstretching during storage (use only suitable connectors!).
11.2 Storing Sterile Instruments

To guarantee the sterility of instruments until they are used on/in the
patient, anti-microbial packaging is absolutely essential.
Further requirements for the protected storage of sterile supplies and the
prevention of corrosion damage include a dust-free and dry environment
and the prevention of temperature fluctuations. These conditions allow
items to be stored for six months (or more). For details, refer to DIN EN 868
Sterile items store and Table 1 of the German standard DIN 58 953, Part 9.
Proper storage of sterilized endoscopes requires that they be kept with the
shaft unkinked and/or laid out in a sufficiently large loop.
12. Surface Changes: Deposits,

Discoloration, Corrosion, Aging,
Swelling and Stress Cracks
In practice, many medical products are subject to surface changes over time
due to chemical, thermal and/or physical impacts. If not directly caused
by normal usage, the origin of such changes can usually be found in the
reprocessing conditions.
If surface changes occur, it is advisable to proceed systematically in the

following order in order to remove and avoid surface damage.
n Determine the nature, origin and cause.
n Estimate the risks.
n If necessary, process/treat the items in accordance with the
manufacturer's recommendations to correct the changes.
n Take appropriate measures to prevent re-occurrence, then validate your
entire instrument reprocessing process.
Reworking or repair of affected products only makes sense if the causes of

the surface changes have been determined and eliminated.
All examples given below are based on the systematic approach outlined
above. These examples cover the most frequent surface changes in metallic
instruments made of stainless steels and/or plastic or rubber products.

12.1 Metal/Deposits – Organic Residues
Type of surface change Blood residues in the closed
joint area.
Cause: Instrument was closed
for cleaning.
Clean in closed joint area.

Reason: Instrument was open
for cleaning.
Rust and/or blood-colored deposits can often be seen.
Origin and causes Immediately after the operation, as a result of surgical residues
(blood, protein), salt residues, drug residues.
n D
ry residue because the interval between use and reprocessing is too
long.
n Protein fixing, e.g. by disinfectants containing aldehyde.
n Transferred by contaminated cleaning agents and disinfectants.
n Insufficient rinsing after cleaning.
n Insufficient cleaning efficiency due to acoustic shadows in ultrasonic
cleaning.
n Inadequate maintenance of the washer/disinfector.
n Possible protein fixing caused by excessive water feed temperature
(> 50 °C) in first rinsing phase.
n Ineffective rinsing (insufficient water flow through or around the
instruments, insufficient rinse pressure, spray shadows).
n Insufficient cleaning efficiency due to foam formation, for example due
to high amounts of blood or cleaning agent and disinfectant residues
carried over from the ultrasonic or immersion bath.
n Improper loading due to use of wrong instrument trolley/trays or
overloading.
n Insufficient cleaning efficiency, because the instruments/devices were
Overloading not open and/or badly positioned.
Treatment n Recleaning with ultrasound.

recommendations n Targeted manual recleaning.
n Immersion in 3 % H2O2solution (approx. 5 min.).

Preventive measures n Remove all coarse contamination, especially salt saline immediately
after the operation.
n Factors causing drying or fixing exclude: drying by reducing the period
between use and reprocessing (under 6 hours).
n The use of suitable aldehyde and alcohol-free disinfectants for wet
disposal.
n Ensure pre-rinse with cold water.
n Program sequence correction in washers/disinfectors.
Risk assessment n Hygiene risk – danger of infection for patients. Can lead to corrosion
even with stainless steel because blood, for example, contains chloride
ions. If present in higher concentrations, these ions cause pitting and/or
stress-crack corrosion.
12.2 Metal/Deposits – Process Chemical

Residues
Depending on the extent of the residues, instrument type, and surface
condition, bright to dark gray deposits / discoloration may appear in
various sizes. This may become even more apparent following sterilization.
Type of surface change
Surface with visible residues Suitable load carrier for cleaning Incorrect loading/tipped
and rinsing ophthalmic kidney-shaped bowls
instruments
Origin and causes Process chemicals that have not been removed sufficiently (spray
shadows, incorrect loading) during the intermediate and/or final rinses.
Treatment n Wipe off with a low-lint cloth.

recommendations n Acid-based cleaning with special cleaning agents as recommended by
the instrument manufacturer.
Preventive measures Ensure sufficient intermediate and/or final rinsing with fully demineralized
water or correct the loading. The manufacturer's instructions regarding
disassembly and cleaning must be followed strictly!
Risk assessment Particularly in the case of ophthalmic instruments, patients could be

exposed to risk of chemical burns caused by alkali and surfactant residues.

12.3 Metal/Deposits – Spotting Caused by Lime
Rinsing chamber with heavy Consequence: Instruments have

limescale deposits limescale residues
Stains/discolorations of a milky white to gray color. Depending on specific

conditions, these changes may extend across a larger surface or take the
form of irregular spots with sharply defined borders, distributed across the
instrument's surface (and/or the washer/disinfector's internal surfaces).
Origin and causes Excessive lime in the water used for the cleaning stage or at the final rinse.
Treatment n To be wiped off with a clean, low-lint cloth.

recommendations n Acid-based cleaning with special cleaning agents as recommended by
the instrument manufacturer.
Preventive measures n Cleaning and intermediate rinses (as appropriate) with demineralized
water.
n Use of fully demineralized water for the final rinse to prevent stain
formation during machine-based reprocessing.
Risk assessment n Corrosion may developed as a result (see chapter 2).
12.4 Metal/Discoloration – Caused by Titanium

Oxide or Silicates
Type of surface change Discoloration caused by silicates occurs occasionally during instrument
reprocessing in the form of titanium oxide, more frequently in the form
of silicic acid. Such discoloration is especially visible on new and repaired
instrumented, storage systems, washers/disinfectors and sterilization
chambers.
The severity of the discoloration is in part dependent on the surface finish,
any deposits of metal ions (e.g. copper from fittings or the pipe system),
the weight and the positioning of the instruments

Titanium oxide discoloration occurs mostly on reflective surfaces over large surfaces, yellow-brown to
blue-violet, sometimes with a shimmering appearance, in the wash chamber or over the entire
surface of the instrument during machine-cleaning.
Typical silicate discoloration occurs, regardless of the nature of the surface, over large surfaces,
yellow-brown to blue-violet in the cleaning & disinfection process, or in spots, droplet-shaped with
pronounced condensation stain-like appearance during the steam sterilization process.
Origin and causes n Silicate discoloration: During the production of fully demineralized
water, silicic acid is passed as a result of the use of ion exchangers and
reverse-osmosis water reprocessing equipment.
n Silicate discoloration: Silicate-based cleaning agents are carried over into
the final rinse process of machine-based reprocessing due to insufficient
intermediate rinsing or dried cleaning agent solution deposits.
n Silicate discoloration: Increased concentration of silicates in steam
generators, which is carried over to the sterilization steam.
n Titanium oxide discoloration: Silicate-based cleaning agents containing
small (trace) quantities of titanium oxide compounds as a substance
present naturally in the silicates are carried over in the final rinse
process due to inadequate intermediate rinsing or dried cleaning agent
solution deposits.
Treatment n Silicate deposits can be removed by means of acid-based cleaning using

recommendations special cleaning agents as recommended by the manufacturer. Stubborn
deposits can be removed with agents containing hydrofluoric acid.
n Titanium oxides are especially stubborn and cannot be removed
(or at best, cannot be removed completely) using common acid-based
cleaning processes.
n Have the surface mechanically treated by the manufacturer or a
qualified repair service.
Preventive measures Use silicic acid-free, fully demineralized water for the final rinsing during
machine-based reprocessing. Prevent cleaning agent carry-over by:
n Correct tray loading and proper positioning/fixation of items to be
processed with hollow spaces in which liquids can accumulate
(e.g. kidney-shaped bowls).

n Ensure correct functioning of dispensing equipment.
n Ensure sufficient neutralization and intermediate rinsing during
machine-based reprocessing.
n For steam sterilization, use water and steam quality as specified in
EN 285 (Appendix B, Table B1.) or DIN 58946 Part 6.
Risk assessment n No corrosion – only aesthetic effect. There are no findings indicating a
patient risk.
n Discoloration may make visual inspection difficult (e.g. to detect dirt
residues).
n The laser-lettered labels of instruments may be adversely affected
(bleached) when treating them with acid-based cleaners. This may
result in poor legibility, thus impairing or even destroying their coding
function.
12.5 Metal/Discoloration – Caused by Oxidation
Type of surface change Retractors with discolored

black shaft in hardened
Cr-steel with the handle and
blade remaining bright, made
from non-hardenable CrNI
steel.
Clamp in detail: Lock and

ring area
Section - titan valves: Left-

hand Valve – brand new.
Right-hand valve – machine-
cleaned.
The change in color is gener-

ally even. However it can also
occur in patches.
A shiny, gray-black passive chromium oxide layer is only formed in the

case of hardenable non-stainless steels, frequently initially identifiable
with cutting instruments (e.g. scissors), but also in the case of non-cutting
instruments (e.g. forceps, thumb forceps).
In the case of titanium materials (pure titanium or alloys) surface

discoloration may be formed with uniform varying coloration (e.g.
gray, blue, violet, red, golden yellow, green) or with blotchy multicolor
discoloration.

Origin and causes In the case of the above stainless steels, the passive layer is formed during
automated cleaning as a result of the neutralizer carried during the
final rinsing and/or by other as-yet unidentified factors forming passive
layers. Passive layers may be transparent (is usual) to black in the case of
stainless steels, depending on the composition, density and thickness. The
tendency to form gray-black chromium oxide passive layers depends, in
particular, on the ratio of chromium content/carbon content, alongside
the influences of the material composition referred to above. In practice,
this means that the higher the carbon content, the faster a gray-black
discoloration may become visible.
In the case of titanium materials, damp heat and/or cleaning chemicals

used in the various reprocessing stages may lead to oxidation of the
surface and hence to discoloration of the surface.
Titanium oxide deposits may be transparent or multicolored/colored

depending on the composition, density, and thickness.
Treatment Repair of the damage by the user is not recommended due to the
recommendations properties of the deposit, but may be carried out by the manufacturer or
a qualified repair service if necessary. In both cases, appropriate surface
treatment is required (mechanical in the case of steel, chemical in the case
of titanium). In the case of stainless steels, removing the deposit with a
basic cleaning agent has no effect on account of significantly increased
resistance to corrosion.
Preventive measures In the case of stainless steels, ensure precise dosing of the neutralizer.
Exclude carry over of the neutralizer with adequate final rinsing.
In the case of titanium materials, virtually unavoidable or not avoidable,
since the nature of the material means it always reacts with the surface
more or less visibly as a result of the ambient conditions prevailing during
reprocessing (temperature, process chemicals, humidity).
Risk assessment No corrosion – aesthetic effect.

If, in the case of titanium materials, any identification/coding function lost
as a result of discolorations, e.g. color coding of the blade width in the
case of valves (see picture), does not present a safety risk, color changes
due to the formation of different properties of oxide layers is completely
unproblematic. That is to say, there are no restrictions with regard to
biocompatibility, hygiene, function or lifetime.
Discoloration may make visual inspection difficult (such as detecting dirt
residues).

12.6 Metal/Discoloration – Caused by Stripping
of Colored Plasma Layers
Example: black, TiAIN coated punch. The partial erosion of the layer has caused bright, colorful
discoloration or complete removal of the layer with undamaged gold-plated components.
Right Punch: as new
Origin and cause Surface reaction caused by cleaning solutions to which hydrogen peroxide
has been added, and/or wash solutions such as those with high alkalinity
at pH > 10, combined with temperatures of above 70 °C. This affects black
titanium aluminum nitride (TiAlN) and titanium aluminum carbonitride
(TiAlCN) layers as well as products/components coated with originally
goldish-yellow zirconium nitride (ZrN) and titanium nitride (TiN).
Treatment recommendations As a result of repair, recoat.
Preventive measures Use only neutral or mild alkaline cleaner. Do not exceed a temperature
of 70 °C when using alkaline cleaners.
Risk assessment Reduced wearing properties and increased light reflection.
Note: Because of the extremely strong cleaning effect of such special

cleaning programs the friction surfaces of metal instruments must be
oiled following each step of cleaning. Otherwise, there is a high risk of
"metal pitting" or friction corrosion.

12.7 Metal/Corrosion – Pitting
Scissors with pitting Example of pitting Example of pitting
Example of pitting Example of pitting Example of pitting
Pitting - seen under a scanning Pitting on tweezers. Cause: Over-aging of color-coding band allows
electron microscope harmful substances containing chloride to infiltrate.
- 200x magnification
Origin and causes Pinprick-like corrosion holes in stainless steel, frequently microscopically
small, surrounded by sparkling, reddish-brown or multi-colored corrosion
spots, often associated with circular corrosion deposits around the corrosion
hole. (Not to be confused with material-specific cavities or foreign-matter
inclusions that may occur in low-quality instrument steels or with contact
corrosion symptoms when only stainless steel instruments are used.)
n In stainless steel, caused by exposure to halide ions (bromides, iodides

and chlorides), but especially chlorides, that locally break through the
passive layer of instrument steel, thus causing pitting.
n Dried-on organic residues, e.g. blood, pus, secretions
(see chapter 12.1 Metal/Deposits - Organic Residues).
n Frequent pitting is due to the use of liquids with a high chloride content,
or more specifically, due to dry residues of such liquids adhering to the
instrument surfaces, e.g. if the concentration of chlorides in the final rinse
water is too high or if residues of physiological salt solutions remain on
the instruments.
n Brand new instruments are particularly susceptible to attack by media
containing chlorides due to their still-thin passive layer. Instruments that

have been in use for some time are more resistant to chloride attack
because they have developed a thicker passive layer.
Treatment Corrosion by-products can be dissolved with an acid-based cleaning agent

recommendations used in accordance with the manufacturer's specifications. The remaining
corrosion holes may be treated mechanically (reworking either by the
manufacturer or by a qualified repair service provider). If pitting is deeper,
long-term repair is often no longer possible. The instrument must be
replaced.
Preventive measures Chloride-induced pitting can be largely prevented by using low-chloride

water qualities, by minimizing organic residues or other effects of chloride-
containing liquids, such as physiological saline solution on instrument steel.
Risk assessment n Corroded instruments should be immediately withdrawn from service

(and the instrument processing cycle) in the interest of patient and user
safety.
n To retain the value of instruments, the causes of pitting must be
eliminated.
n Corrosion holes can pose a hygienic hazard and may lead to stress
corrosion cracking as well.
12.8 Metal/Corrosion – Wear Friction Corrosion
Hinge area (scissors) Bone punch, friction surface on Prevention: Careful treatment
sliding section indicates onset of with instrument oil
friction corrosion.
Brown stains/discolorations or rust formation around an area that has been

chafed.
Origin and causes Insufficient lubrication and/or foreign bodies lead to corrosion of the
metallic friction surfaces/instrument components that move relative to each
other (especially in ends/joints and sliding rails, e.g. with punches). This
forms micro-abrasion, which can make the surface extremely rough and
destroys the passive layer. In these sensitized areas, humidity or deposits
(e.g. blood residues) can easily accumulate - a process that usually leads to
corrosion.

Treatment n Discard defective instruments or have them repaired where possible.
recommendations n Regrinding and/or polishing can usually repair corrosion damage.
n Repeated reworking affects the handling/controllability and thus the
functionality of the instrument, making it useless.
Preventive measures n Allow the instruments to cool down to room temperature.

n Proper instrument care and servicing = accurately applying care products
to the instrument prior to performing the functional check.
n Manually apply the care product directly to the joint area (using drops or
spray).
n Distribute the care product uniformly in the joint by opening and closing
the instrument in the joint area several times.
Requirements for instrument care products:

n Basis of care product: liquid paraffin (paraffin oil)/white oil.
n Must conform to currently valid pharmacopeia.
n Must be vapor-permeable/suitable for steam sterilization at the boundary
surface between the material and the oil film.
n Jamming of the joints due to accumulated lubricant must be prevented.
Risk assessment Do not use lubricants on rubber or latex products, as this leads to swelling.
Friction corrosion impairs or completely destroys the instrument's

functionality. Friction corrosion may lead to pitting.
12.9 Metal/Corrosion – Stress Corrosion

Cracking
Type of surface change Detail: Scissors hinge joint

with typical intercrystalline
crack.

Detail: Jaw clamp with typical
grainy, intercrystalline
fractured structure.
Origin and causes Stress corrosion cracking usually leads to visible cracks and fractures.
In some cases, crack formation is not visible because its origin is hidden by
design (e.g. in the joint of a pair of scissors), and the crack may propagate
until failure.
Very frequently, the non-deformed and possibly hidden fracture surfaces

are indicative of the growth of the crack (typically associated with
corrosion products).
This type of corrosion often affects areas or components that

n are subject to high tensile stress due to design and/or manufacturing
reasons (such as rivet or screw connections, welded or soldered
connections or so-called press fit connections).
n exhibit excessive stress caused by improper repair work (e.g. poorly
performed repairs) or
n have been reprocessed under high stress (e.g. when the ratchet is fully
closed) or.
n Processing overstressed or strained instruments in a corrosion-promoting
environment, especially at higher temperatures.
The main corrosion cause is water containing chlorides, but surgical
residues, drugs and the like must also be taken into account.
Treatment No remedial measures can be named. The damage is irreparable.

recommendations
Preventive measures n Clean articulated instruments in an open position and sterilize them
with the ratchet locked in the first tooth.
n Reduce the chloride load to a minimum (for example, reduce surgical
and drug residues; use only suitable water for reprocessing, final rinse
and sterilization).
n Avoid improper handling that could lead to overstressing.
n Have your instruments repaired only by the manufacturer or a qualified
and specially authorized repair service provider.
Risk assessment n Corroded instruments should be immediately withdrawn from service

(and the instrument processing cycle) in the interest of patient and user
safety.
n To retain the value of your instruments, eliminate the cause of
corrosion.

12.10 Metal/Corrosion – Surface Corrosion
12.10.1 Stainless Steels
Surface of blade affected due to Material affected at partially Etching effect on surface of
humidity. Cause: Composition defective chrome coating. Cause: instrument. Cause: Effects of
of materials, normal steel, so Humidity causes corrosion to over-dosed acids.
disposable product. form on unprotected carrier
material (normal steel)
Partial etching effect and deposits of an etching agent causing hemostasis on the surface of the
instrument. Cause: contact time too long
Etching effect on soldered seams. On carbide metal scissors, carbide tweezers and needle holders
Cause: Effects of acid due to over-dosing of neutralizing chemicals or due to using acid-based cleaners.
n On stainless steel mostly a uniform, flat-gray surface attack that quite

often leads to subsequent damage in the form of corrosive deposits.
n In non-stainless steel products (e.g. disposable products such as scalpel
blades, or old instruments not made of stainless steel, typically with
damaged or peeled-off chromium surface layers), usually extreme
corrosion on a matt black surface.
n Discoloration and erosion of materials at solder points and sintered
carbide inserts made of tungsten carbide and cobalt
(TC/CO mixing ratio 9:1).
Origin and causes n Chemical and electrochemical effects only in connection with an
excessive acid content with
n stainless steel,
n soldering points.

n Long-term impact of water/condensate in the case of stainless steel.
Treatment n Rust removal by means of acid-based cleaning in the case of stainless

recommendations steel if the damage is still superficial and/or mechanical treatment of
soldering points (if appropriate) by the instrument manufacturer or a
qualified repair service provider.
n If sintered carbide (TC/CO) surfaces are affected, the damage is
irreparable.
Preventive measures n In the case of soldered instruments, always observe the application
recommendations when using acid cleaners and neutralizers.
n Discard disposable products made of steel or old steel instruments with
damaged coatings and replace with stainless steel products.
n Avoid long-term exposure to moisture (condensate).
Risk assessment n If surface treatment proves ineffective, replace the affected instruments
with new ones (otherwise there is a risk of secondary rust formation or
extraneous rust).
12.10.2 Anodized Aluminum

Material affected at aluminum Material affected on natural/colored anodized aluminum surface of

handle. Cause: Unsuitable containers. Cause: alkaline washer solution above permitted level
alkaline cleaner
n In naturally anodized surfaces, whitish-gray corrosion products, with

crater formation in cases of strong attack.
n In colored, anodized surfaces, color partially or completely faded, with
discoloration and material erosion in cases of strong attack.
Aluminum corrosion is characterized by the discoloration of the surface and

the presence of a white, powder-like coating.
Origin and causes n Effect of acids or too high alkalinity in anodized surfaces.
Treatment n No longer reparable.

recommendations

Preventive measures n Treat in neutral/mild alkaline pH environment.
Risk assessment n Loss of color-coding function.
12.11 Metal/Corrosion – Contact Corrosion

Examples of crevice corrosion
Type of surface change caused by contact between
instruments
Origin and causes The classic variant of contact corrosion occurs in a material combination
involving stainless steel and non-ferrous metals (German silver, brass,
copper). Depending on the ambient conditions, e.g. humidity, this
generally also leads to corrosion deposits in the contact areas and usually
beyond them as well. This combination only occurs rarely in practice, as
there are problems with non-ferrous metals regarding biocompatibility.
Treatment In the classic material combination stainless steel/brass, when the

recommendations instrument stock typically contains old and new instruments (old/chrome-
plated and new/stainless steel instruments), this type of corrosion occurs
during cleaning as well as during sterilization, due to a damaged and/
or incomplete chromium or nickel layer (e.g. in the case of sharp curettes
with hollow handles or retractors).
If contact corrosion occurs as a result of protective layer damage in nickel

or chrome-plated instruments, there is usually no remedy. If in doubt,
contact the instrument manufacturer.
Preventive measures Replace nickel or chrome-plated instruments which have damaged

(scaly, peeled-off ) protective layers with stainless steel instruments.
Risk assessment However, when both stainless steel and non-ferrous metals are combined,
considerable rust damage can be caused to intact instruments, depending
on the extent of the damage involved.

12.12 Metal/Corrosion – Extraneous and Film
Rust/Subsequent Rust
Type of surface change Filter holder with
corrosion in the form of
particulate
n Individual, irregularly dispersed rust particles.

n Brown, mostly localized corrosion deposits/rust.
n In the event of direct, wide-area contact with very rusty products,
subsequent rust damage may occur in the area of the contact surfaces.
Origin and causes n Rust particles carried over from the pipework.
n Use of water containing iron or rust, or use of steam containing rust
particles.
n Corrosion products (rust) that adhere to non-corrosion-resistant
disposable products such as scalpel blades, may be dislodged during
the sterilization process and dispersed over other instruments.
n Reprocessing of non-corrosion-resistant steels (often old instruments)
whose protective layer has been damaged or completely dislodged.
Treatment Given a slight and only superficial attack, removal of the deposits with
recommendations acid-based cleaning may be an option (only for stainless steels), but it is
necessary to check afterwards whether the instrument surface is still intact.
Provided the damage is still superficial, it may be possible for the

instrument to be treated mechanically (reprocessed) by the manufacturer
or a qualified repair service provider.
Preventive measures n Disposable items made of steel must not be reprocessed.

n Discard, or treat separately, any non-stainless instruments and materials.
n Avoid using low-value, unapproved products (e.g. accessories available
in DIY stores).
n Carry out effective construction measures to prevent pipework rust
particles from entering the cleaning and sterilization stages.
(For example, by filtering the feed water mechanically before it enters
the washer/disinfector or sterilizer).
Risk assessment n Rust deposit on instruments or device components including

accessories may give rise to secondary rust on instruments that have
previously not been affected. The effect is dependent on the quantity
present beforehand, the proximity of the instruments to one another
and time.

n If rust particles are carried over from the pipework, many of the
instruments processed may be affected and thus lose value.
12.13 Metal/Corrosion – Crevice Corrosion

Type of surface change Joined area - tweezers ends
n Since crevice corrosion is a locally-accelerated type of corrosion, it leads

to corrosion deposits only in crevice areas (e.g. in the joint crevice of the
two halves of a pair of forceps, in joint gaps or in pressed-in or screwed-in
the tips of probes, for example). Crevice corrosion can also occur in gaps
between metal and other materials.
n Frequently residues (particularly organic ones) are mistaken for crevice
corrosion.
n With crevice corrosion that has developed as a result of storage, small
dot or ring-shaped, brownish-blue discolorations with slight corrosion in
the contact areas can occur. This type of crevice corrosion is frequently
mistaken for pitting. Upon closer examination, however, it becomes clear
that there is no hole in the center of the corrosion spot. In specific cases,
the surface structure may be rubbed slightly smooth in these areas as a
result of vibration.
Origin and causes n Crevice corrosion tends to occur in gaps of critical width if the prevailing
ambient conditions favor it (e.g. insufficient drying). Under these
conditions the passive layer is vulnerable to attack. It can no longer
regenerate, as the oxygen supply to the metal surfaces is impeded. The
rust then works its way out of the gap or crevice. Rust formation occurs in
the presence of humidity and higher salt concentrations.
n Crevice corrosion developing as a result of storage has only been
observed following machine-cleaning to date. Microfriction at the contact
points leads to partial abrasion of the passive layer. Thus the corrosion
protection is temporarily removed in these places, which in turn leads to
the surface changes described above.

Treatment n Treat affected instruments in accordance with the manufacturer's
recommendations specifications.
n Mechanical treatment (reprocessing) of the instrument by the
manufacturer or an authorized repair service.
n Experience has shown that storage-related crevice corrosion disappears
after just a few reprocessing cycles. Acidic media (neutralizers) usually
dissolve these deposits at once, while also accelerating the passivation
process.
Preventive measures n Remove coarse contaminants immediately.

n Use rinsing water with a low salt content (preferably fully demineralized
water).
n Dry joints or gaps adequately.
n Avoid vibration when cleaning stainless steel instruments
(e.g. ultrasound treatment, machine-based reprocessing) to prevent
storage-related crevice corrosion (e.g. by ensuring that the cleaning/
disinfecting apparatus, or W/D, stands firmly on level ground).
Risk assessment Rust cannot spread to other instruments in most cases. In severe cases,
however, the rust might affect intact instruments and cause subsequent
damage there as well (also see "Extraneous and Film Rust/Subsequent rust").
With storage-related crevice corrosion, experience has shown that there

is no danger to the affected instruments or to unaffected instruments,
because the minor deposit volume is not sufficient to cause damage,
unless the phenomenon cannot be eliminated by further reprocessing
using acidic media.
12.14 Plastic/Rubber – Aging

Type of surface change Aging tears in a breathing
mask
n Brown stains/discolorations, possibly crack formation in rubber and latex

products.
n Softening or hardening.
n Many plastic materials turn yellow or harden.
n Silicone elastomers are extremely resistant to aging but tend to turn
yellow.
Origin and causes n Impact of dry heat.
n Straining and overstretching during storage.

n Sunlight, UV radiation.
n Effect of oxygen (oxidation, true aging).
n Effect of ozone.
n Maximum time between applications/reprocessing exceeded.
Treatment None (cannot be corrected)

recommendations
Preventive measures If possible store instruments in dark and cool conditions
Risk assessment If the changes affect applications or risk, discard affected instruments
(depending on aging condition).
12.15 Plastic/Rubber – Swelling

Swollen insertion tube caused Right: Swollen seals caused by Right: Leaking flap valve on a
by using unsuitable care agent. incorrectly applied instrument trocar caused by the seal
oil. swelling as a consequence of
Left: New seals contact with oil.
Left: New flap valve
n Swollen, softened, sticky surfaces of plastic, rubber or latex products.

n Thin-walled parts can split open or burst.
n Material becomes brittle and hardens.
Origin and causes Swelling is caused by the penetration of gases or liquids into the surface.
Swelling can be reversible and temporary if due to the impact of volatile
spray solvents or propellants. The same symptom can also occur if rubber
or certain plastics come into contact with gaseous anesthetics.
However, irreversible swelling can be caused by contact with oils
(paraffin oil), Vaseline and unsuitable disinfectants (e.g. phenol
derivatives). Silicone rubber shows a reversible reaction to spray
propellants and gaseous anesthetics, but irreversible damage is caused by
silicone oils, solvents and some disinfecting agents (e.g. amines).

recommendations

Preventive measures Avoid contact/exposure, depending on material (see "Origin and causes").
Risk assessment Depending on degree of swelling, stop using affected instruments if

existing surface changes are application- and/or risk-relevant.
12.16 Plastic – Stress Cracks

Type of surface change Stress crack
Stress-crack corrosion, e.g. in polysulphone, leads to visible cracks or

fractures.
Origin and causes Stress cracks tend to occur in those areas of a medical product in which
increased "inherent" stresses are present as a result of the manufacturing
method.
Under specific instrument reprocessing conditions (e.g. insufficient rinsing,

high temperatures, presence of certain surface-active chemicals), cracks
tend to develop in these areas.

recommendations
Preventive measures Do not use process chemicals that favour the formation of stress corrosion
cracking. Ensure a sufficient final rinse with demineralized water. The
manufacturer's specifications regarding reprocessing must always be
observed.
Risk assessment Affected instruments should be withdrawn from service (and the
instrument processing cycle) at once in the interest of patient and user
safety!

Notes:

13. Glossary
A0 value The A0-value concept
The A0 value of a disinfection process using moist heat expresses lethality as a time equivalent
in seconds at a heat transfer temperature of 80°C, with reference to micro-organisms for which
the z value is 10°C.
Acidic cleaner Acidic cleaners are either based on phosphoric acid for the removal of organic residues,
limescale or rust caused by dip processing, or on inhibited hydrofluoric acid for the removal of
silicate discoloration. When applying these, the application and safety information provided by
the manufacturer must always be heeded.
Acoustic shadows Acoustic shadows occur for example in an ultrasonic bath behind objects which stand in the
direct path, obstructing the source of sound.
Anion exchanger Equipment to replace negatively charged ions (anions) dissolved in water such as chlorides,
sulfates and nitrates against hydroxide ions by way of full demineralization.
Anodized A surface finish used on aluminum. The "anodized" layer (Al2O2 • H2O aluminum oxide hydrate)
is silver-gray in color and is created by electrolytic passivation (anodizing) to protect products
against wear and corrosion. Dyes can be added to give a variety of colors.
Anti-microbial Effective against micro-organisms. This is a more general term which provides no indication as to
the type and extent of deactivating action.
Aseptic Measures to prevent infection or contamination.
Bacteriostatic Preventing bacterial growth.
Boiler feed water Water used to produce steam in a boiler.
Carbide metal Carbide metals produced in a sintering or casting process which are extremely hard and
impervious to wear.
Cation exchanger Equipment to replace positively charged ions (cations) dissolved in water such as calcium and
magnesium cations against sodium cations by way of partial demineralization or hydrogen ions
by way of full demineralization.
CE mark/medical product Confirmation that the manufacturer of a product has performed a conformity assessment
according to EU Directive 93/42/EEC.
Chemo-thermal process A process in a washer/disinfector designed for heat-sensitive products, allowing only
reprocessing at defined temperatures up to 65°C combined with the use of a disinfectant in a
specified concentration over a defined exposure time.
Chlorides Salts of hydrochloric acid, often occurring as sodium chloride or potassium chloride dissolved for
example in water or blood.
Table salt and reactivation salt consists of sodium chloride which is also a constituent of
physiological salt solution.
Cleaning Removal of contamination from an object to a degree which renders the item fit for further
reprocessing or its intended use.
Color anodized Signifies the use of dyes in anodizing or the decorative coloring of aluminum, for instance by
means of immersion coating. Standard colors include gold, blue, red, black, etc.
Contamination Contamination with undesirable substances including micro-organisms.
Corrosion In general terms, corrosion refers to the degradation of surfaces as a result of environmental
influences, e.g. substances with a critical chloride content (blood, salt solution, etc.) on stainless
steels.
Decontamination Process to dilute contamination and deactivate pathogens in the instrument reprocessing cycle.

Denaturation of proteins Modification of natural protein structures by chemical influences or heat.
Disinfection Process to reduce the bacterial titer count to a predetermined level suitable for handling or use.
Dispersion Stable homogeneous distribution of water-insoluble contaminant particulates in a cleaning agent

solution (contaminant carrying capacity).
Distal end The distal end of an instrument is the end closest to the patient, e.g. the jaws of forceps.
Electrical conductivity Used in water analyses to measure the total content of dissolved and electrically conductive
mineral salts.
Emulsification Suspension of insoluble liquids in a cleaning agent solution for removal.
Evaporation residue The non-volatile components in water (e.g. mineral salts) in mg/l which remain behind after a
pre-determined drying process.
Flaws Exposed surface defects caused by material (e.g. purity) or production process
(e.g. folds, cracks, pores).
Halides Collective term for chlorides, iodides and bromides with similar chemical properties.
Heat-resistant instruments Medical products and accessories which can be thermally disinfected and sterilized using steam.
HF instruments Instruments for high-frequency surgery (HF).
Inert gases Non-condensing gases used in steam sterilization are referred to as inert gases. These include
carbon dioxide or oxygen.
Interfacial tension Forces that occur on the contact surfaces between two phases. Between liquid and gas phases,
these are referred to as surface tension.
Ion exchanger Collective term for cation, anion and mixed-bed ion exchangers.
Lumen Passageway in hollow instruments.
Martensitic The term used to describe the micro-structure of materials which develops when steel is
hardened through quenching.
Micro-structure A micro-structure is the internal structure of a material. In metals, this generally refers to the
crystalline or grain structure which results from the production process or heat treatment.
In the case of stainless steels, the micro-structure determines a material's properties, for instance
hardness or elasticity or its tendency to wear or corrode.
Minerals causing water Calcium and magnesium salts dissolved in water.

hardness
MIS instruments MIS instruments are instruments used in minimally-invasive surgery.
Mixed-bed ion exchanger Combination of cation and anion exchanger used in the full demineralization of water.
Morphology Morphology significantly defines the functional properties of an instrument's surface. Put simply, it
refers to the micro-structures on the surface or directly around the surface
Non-wovens In this context, can refer to a non-woven composite fiber fabric used for sterile barrier systems
(SBS) made from textile or non-textile fibers (EN 868-2:2009).
Notified Body A body designated by an authority or institution to certify quality assurance systems and medical
products on the basis of the Medical Device Directive.

Organic residue Residues such as blood, protein and tissue, mainly from the human body.
Oxidation A chemical reaction of a substance with oxygen.
Passage of silicic acid Problem relating to the full demineralization of water using ion exchangers. Silicic acid passes
through an ion exchanger without increasing the electrical conductivity of demineralized water.
pH value The pH value is a measure of the acidity or alkalinity of aqueous solutions.

pH < 7 = acidic
pH = 7 = neutral
pH > 7 = alkaline
Pharmacopeia Official listing of medications.
Prions Protein folding error causing transmissible spongiform encephalopathies (TSE) such as BSE,
CJD and vCJD.
Process chemicals Collective term for the chemicals such as detergents, disinfectants, neutralizers, surfactants and
instrument milk used in instrument reprocessing.
Protein fixation Process which changes the structure of proteins, resulting in more difficulty in cleaning. Proteins
modified through chemical influences or heat are more difficult to remove from surfaces.
Protein interference The degradation/deactivation of certain disinfectants (e.g. active chlorine) when coming into
contact with proteinaceous contaminants.
PVC Polyvinyl chloride - Type of plastic frequently used in medical technology.
Reactivation salt Salt used to reactivate water softeners operating on the cation exchange principle. Consists
mainly of sodium chloride.
Redeposition The process in which soil already removed from a surface resettles.
Reprocessing Measures taken to render medical products and accessories safe for use for a specific purpose.
Rhodium A metal with a silver-gray sheen.
Roughness Refers to the unevenness of a surface.
RUMP Reprocessing Unit for Medical Products.
Rust Rust is the product of corrosion on iron, steel and steel alloys as a result of oxidation, a reaction
with oxygen in an atmosphere containing water.
Saturated steam Steam in a state of equilibrium between condensation and evaporation.
Silicic acid Acid contained in water which is in the acidic range. The salts of this acid are referred to as
silicates.
Slip agents Slip agents are used when introducing probes, endoscopes and ultra-sound devices in order to
prevent irritation to the skin and mucous membranes.
Spray shadows Spray shadows are areas within a washer/disinfector shielded by large and improperly positioned
items, preventing water jets from accessing the load directly.
Stainless steel/high-grade According to DIN EN 10020, high-grade steel refers to alloyed and unalloyed steels that exhibit
steel a special/higher level of purity due to their production process. This is the case if its sulfur and
phosphorus content does not exceed 0.025%. High-grade steel does not necessarily satisfy the
specifications of stainless steel, for which there must be minimum amount of chrome present,
see 1.1 Material Selection.
Steam sterilization A validated process to eliminate micro-organisms on products using saturated steam
(according to ISO 17665).

Sterile filtration Filtration of liquids, e.g. the water used in a final rinse, using a filter which prevents the passage
of bacteria (pore size <= 0.2 µm).
Sterilization A process to remove all micro-organisms from a product.
Surface tension Property of water and aqueous solutions in contact a gas phase (atmosphere), caused by the
polarity of the water molecules. The surface of water appears to form a skin.
Tactile Referring to the sense of touch.
Thermal process Process in a washer/disinfector using damp heat as the disinfecting agent.
Thermolabile instruments Medical products and accessories which cannot be thermally disinfected or sterilized using
steam.
Topography Also referred to as a surface texture, describes the geometric form of technical surfaces or
micro-structures.
Washer-disinfector load Collective term for medical products and accessories which require cleaning and disinfection.
Water softening Water reprocessing procedure in which cation exchangers are used to remove the hardness
(calcium and magnesium ions) from water by replacing these with sodium ions.
z value Temperature change in K required to achieve a tenfold change in the microbiological deactivation
rate in a disinfection process using moist heat. Source: ISO 15883:2006-07.

14. Bibliography 16. EN ISO 17665-1: 2006-11
Sterilization of Healthcare Products
Because standards are subject to constant revision, the
information in this booklet relate to the printing date. The 17. ASTM A 380 – 13
up-to-dateness of the standard must be verified as appropriate. Standard Practice for Cleaning, Descaling, and Passivation
of Stainless Steel Pparts, Equipment, and Systems
1. EN ISO 15883
Requirements, Definitions, Tests 18. ASTM Designation: A967-13 Standard Specification for
Part 1-2, 2009 Chemical Passivation Treatments for Stainless Steel Parts
Part 4, 2009
Part 6, 2015 19. EN ISO 17664: 2007
Part 7, 2016 Information to be Provided by the Manufacturer for the
Cleaning/Disinfecting units Reprocessing of Resterilizable Medical Products
2. EN 16442, 2015 20. ISO 14937: 2010

Storage cabinet with controlled environmental conditions for Sterilization of Healthcare Products - General Criteria for
reprocessed, heat-sensitive endoscopes Characterization of a Sterilizing Agent and the Development,
Validation and Routine Control of a Sterilization Process for
3. EN 285: 2015 Medical Products
Sterilization – steam sterilizers – large-scale sterilizers
21. DIN 13940-1: 2016-07
4. EN 868; Parts 1 to 10 Dentistry, Dental Handpieces; Coupling Dimensions
(individual parts published in different years) Packaging materi-
als and systems for medical products which are to be sterilized 22. ISO 3964: 2016
Dental (Drill) Handpieces; Coupling Dimensions
5. EN ISO 11607, Part 1: 2009, Part 2: 2006, Packaging (For Connection to Drive)
materials for the final packaging of products to be sterilized
23. DIN Pocket Book 100: 2010
6. EN 10088: 2014 Medical Instruments
Stainless steels Beuth Verlag GmbH, D-10787 Berlin
7. EN ISO 7153-1: 2017 24. DIN Pocket Book 169: 2008

Surgical instruments - Metallic materials Sterilizers, Device Requirements
Part 1: Stainless steel Beuth Verlag GmbH, D-10787 Berlin
8. ASTM Designation: F889 - Standard Specification of 25. Directive 93/42/EEC of the European Council on Medical
Wrought Stainless Steel for Surgical Instruments Products of June 14, 1993 (OJ EG No. L 169 p. 1)
most recently amended by Article 2 of Directive 2007/47 of
9. DIN 96298: 2010 September 5, 2007 (OJ L 247, p. 21)
T1: Med. Instruments - Terminology, 2016 entered into force October 11, 2007
T2: Med. Instruments - Measurement Methods for the
Identification of Basic Dimensions of Standard Surgical 26. BGV A1 and Safety Organization Rules of the Statutory
Instruments, 2016 Employer's Accident Insurers, such as BGR 250, BGR 206
T3: Med. Instruments - Inspections, 2017 issued by the Berufsgenossenschaft für Gesundheitsdienst
und Wohlfahrtspflege (Statutory Accident Insurer for
10. EN ISO 16061: 2015 Healthcare and Welfare Employers)
Instruments Used in Conjunction with Non-Active Surgical
Implants. 27. Current edition of the VAH List of Disinfectants tested in
accordance with the guidelines for testing chemical
11. EN ISO 13402: 2001 disinfectants, and approved by the German Association of
Surgical and Dental Hand Instruments. Determination of Hygiene and Microbiology as being effective disinfecting
Resistance Against Sterilization, Corrosion, and Thermal procedures (including hand decontamination and hygienic
Exposure hand-washing procedures).

12. ASTM Designation: F 1089 Standard Test Method for 28. Current edition of the list of disinfectants and procedures
Corrosion of Surgical Instruments tested and recognized by the Robert Koch Institute
13. ISO 7151: 1988 29. European Pharmacopeia

Surgical Instruments; Non-Cutting, Articulated Instruments;
General Requirements and Test Methods 30. Gray booklet
"Trials and Statements"
14. ISO 7741: 1986 publication of AKI, 1999
Instruments for Surgery; Scissors and Shears; General available at www.a-k-i.org
Requirements and Test Methods
31. Returned goods at medical institutions, factsheet on
15. DIN 58946 - Part 6: 2002 recommended treatments, BVMed, www.bvmed.de
Sterilization – Steam Sterilizers,
Part 6: Operation of Large-Scale Sterilizers in Healthcare

32. RKI recommendation
Hygiene requirements for the sterile reprocessing of medical
devices
Recommendation of the Commission for Hospital Hygiene
and Infection Prevention (KRINKO) at the Robert Koch
Institute (RKI) and the Federal Institute for Pharmaceutical
and Medical Products (BfArM);
Federal Health Gazette 2012 · 55:1244–1310
33. EN ISO 10993-1, 2009-03

Biological Evaluation of Medical Products
34. EN 14885, 2015

Chemical Disinfectants and Antiseptics
35. EN 10020: 2000

Definitions for the Classification of Steels
36. Biering, H.
Comparing AAMI Standards With the "Red Book".
Biomedical Instrumentation & Technology.
2012; 46 (3):184-188.
37. ANSI/AAMI ST79:2010 & A1:2010 & A2:2010 & A3:2012,

Comprehensive guide to steam sterilization and sterility
assurance in health care facilities. Association for the
Advancement of Medical Instrumentation; 2010, 2011.
38. AAMI TIR12:2010,

Designing, testing, and labeling reusable medical devices
for reprocessing in health care facilities: A guide for medical
product manufactures. Association for the Advancement of
Medical Instrumentation; 2010, 2011. Arlington, VA
39. AAMI TIR30:2011,

A compendium of processes, materials, test methods, and
acceptance criteria for cleaning reusable medical devices.
Association for the Advancement of Medical Instrumentation;
2010, 2011. Arlington, VA
40. AAMI TIR34:2007,

Water for the reprocessing of medical devices. Association
for the Advancement of Medical Instrumentation; 2010, 2011.
Arlington, VA

15. Schematic Flow Chart as per EN ISO 17664

Notes:

AKI sales conditions:
1. This brochure does not replace the manufacturer's specifications on the
reprocessing of medical products. The ordering party undertakes not to
use this brochure in conjunction with the marketing of medical devices
and to refrain from any activity which may suggest that the brochures
contain manufacturer specifications.
2. AKI retains exclusive copyright and all other proprietary rights for the
brochures prepared by AKI. Duplication or the use of charts, images and/
or texts in any other electronic or printed publications is prohibited
without the express permission of AKI.
3. It is not permissible to add advertising to brochures or downloadable

files sourced from AKI. This also applies to flyers.
4. Any action which contravenes one or all of the obligations described

in Sections 1–3 is subject to a EUR 500 penalty and the offender must
immediately cease and desist from any such infringements.
5. AKI booklets may be purchased in quantities exceeding 5 copies. Please

see our website www.a-k-i.org for prices and purchase conditions.
Legal Notice
Instrument Preparation Working Group
Chairman and Official Representative of the Working Group: Michael Sedlag
Contact:
Arbeitskreis Instrumenten-Aufbereitung
c/o Miele & Cie. KG | Professional Sales, Service & Marketing
Carl-Miele-Strasse 29
D-33332 Gütersloh
Tel.: +49 (0) 5241 89 1461
Fax: +49 (0) 5241 89 78 1461
Email: [email protected]
Person with editorial responsibility: Michael Sedlag
Disclaimer
This brochure does not replace the manufacturer's specifications on the reprocessing
of medical products. The ordering party undertakes not to use this brochure in con-
junction with the marketing of medical devices and to refrain from any activity which
may suggest that the brochures contain manufacturer specifications. Version 11.0

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Instrument

Previous German-language editions: Current foreign-language editions:

Reprocessing of Instruments to Retain Value, 11th edition 2017, www.a-k-i.org 3

Instruments product group: Disinfectant cleaning and Washers, disinfectors and

Wolfgang Fuchs Sebastian Niebur Robert Eibl

Dr. Gerhard Kirmse Verona Schmidt Markus Hoppe

Helmi Henn Dr. Matthias Tschoerner Michael Sedlag

4 Reprocessing of Instruments to Retain Value, 11th edition 2017, www.a-k-i.org

Endoscopes and MIS: Surgical motor systems: General guests:

Heidrun Groten-Schweizer Rainer Häusler Dr. Jürgen Wegmann

Klaus Hebestreit Marcus Schäfer Anke Carter

Dr. Birgit Kampf Aaron Papadopoulos

Horst Weiss Stefan Bandelin

Elastic instruments: Water treatment:

Roland Maichel Dr. Herbert Bendlin

Reprocessing of Instruments to Retain Value, 11th edition 2017, www.a-k-i.org 5

Authors and Addresses 4

1. Materials and Design 14

2. Media used for instrument reprocessing 18

3. How to Treat Brand New and Repaired Instruments 27

4. Procedure Recommendations for Returned Goods 28

5. Preparation for Cleaning and Disinfecting 30

6. Manual and Automated Cleaning and Disinfecting 33

8. Checks and Care 48

6 Reprocessing of Instruments to Retain Value, 11th edition 2017, www.a-k-i.org

12. Surface Changes: Deposits, Discoloration,

15. Schematic Flow Chart as per EN ISO 17664 88

AKI sales conditions 90

Legal Notice and Disclaimer 90

Reprocessing of Instruments to Retain Value, 11th edition 2017, www.a-k-i.org 7

Efforts to ensure the independence of the departments for sterile supplies

Today, we have reached the next phase, defined by a more unified

AKI's great achievement lies in always having remained within its

8 Reprocessing of Instruments to Retain Value, 11th edition 2017, www.a-k-i.org

"Reprocessing of Instruments to Retain Value", nicknamed the "red book",

Honorary President, World Federation for Hospital Sterilization Sciences

Reprocessing of Instruments to Retain Value, 11th edition 2017, www.a-k-i.org 9

In addition, there are direct legal requirements that need to be observed,

This 11th edition contains extensive updates.

A cross-check has also been conducted comparing reprocessing

* Association for the Advancement of Medical Instrumentation

10 Reprocessing of Instruments to Retain Value, 11th edition 2017, www.a-k-i.org

Surgical instruments Flexible endoscopes

Microsurgical Flexible instruments and

* For detailed information relating to prepro-

Surgical motor systems

Minimally-invasive surgery instruments,

However, one should keep in mind that these product-specific instructions

A wide-spread misconception that "high-grade steel" or "stainless steel"

Nonetheless, as long as you understand the material and its characteristics

Microsurgical instruments require particularly careful reprocessing. Due to

Reprocessing of Instruments to Retain Value, 11th edition 2017, www.a-k-i.org 11

Other instrument groups for which special processing instructions are

Needless to say, users of medical devices expect well-known manufacturers

General notes and Basically, the reprocessing of medical devices comprises:

National regulations, such as the German Operator Regulations relating to

12 Reprocessing of Instruments to Retain Value, 11th edition 2017, www.a-k-i.org

It is particularly important to follow the manufacturer's instructions

For thermostable medical products, machine-cleaning with thermal

2. Media used for instrument reprocessing 18

3. How to Treat Brand New and Repaired Instruments 27

6. Manual and Automated Cleaning and Disinfecting 33

12. Surface Changes: Deposits, Discoloration,

n Cleaners, neutralizers, rinsing and care agents are classified as class I

2.2.2 Properties and assessment of constituent

3. How to Treat Brand New and