Health Technical Memorandum

01-01: Management and

decontamination of surgical
instruments (medical devices)
used in acute care
Part B: Common elements

March 2016

HTM 01-01: Management and decontamination of surgical instruments: Part B Common elements

Health Technical Memorandum

01-01: Management and
decontamination of surgical
instruments (medical devices)
used in acute care
Part B: Common elements

ii

 Crown copyright 2016

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health-building-notes-core-elements
iii

HTM 01-01: Management and decontamination of surgical instruments: Part B Common elements

Preface

Introduction
This HTM supersedes the Choice Framework
for local Policy and Procedures (CFPP) series,
which was a pilot initiative by the Department of
Health.
The CFPP series of documents are reverting to
the Health Technical Memorandum title format.
This will realign them with HTM 00 Policies
and principles of healthcare engineering and
HTM 01-05: Decontamination in primary care
dental practices and the naming convention
used for other healthcare estates and facilities
related technical guidance documents within
England. It will also help to address the
recommendation to align decontamination
guidance across the four nations.
In 01-01 and 01-06 DH will be retaining the
Essential Quality Requirements and Best
Practice format, this maintains their alignment
with HTM 01-05 and the requirement of The
Health and Social Care Act 2008: Code of
Practice on the prevention and control of
infections and related guidance which requires
that decontamination policy should
demonstrate that it complies with guidance
establishing essential quality requirements and
a plan is in place for progression to best
practice. We are aware that policy within the
devolved nations differs on this particular issue
but the aim is that the technical content should
be consistent and able to be adopted by the
devolved nations so that the requirements of
the ACDP-TSE Subgroups amended guidance
can be met.

iv

HTM 01-01 forms a suite of evidence-based

policy and guidance documents on the
management and decontamination of reusable
medical devices.

Purpose
The purpose of this HTM is to help health
organisations to develop policies regarding the
management, use and decontamination of
reusable medical devices at controlled costs
using risk control, which will enable them to
comply with Regulations 12(2)(h) and 15 of the
Health and Social Care Act 2008 (Regulated
Activities) Regulations 2014 .
This HTM is designed to reflect the need to
continuously improve outcomes in terms of:
patient safety;
clinical effectiveness; and
patient experience.

Essential Quality Requirements and

Best Practice
The Health Act Code of Practice recommends
that healthcare organisations comply with
guidance establishing Essential Quality
Requirements and demonstrate that a plan is in
place for progression to Best Practice.
Essential Quality Requirements (EQR), for the
purposes of this best practice guidance, is a
term that encompasses all existing statutory
and regulatory requirements. EQRs incorporate
requirements of the current Medical Devices

Directive and Approved Codes of Practice as

well as relevant applicable Standards. They will
help to demonstrate that an acute provider
operates safely with respect to its
decontamination services.
A healthcare providers policy should define
how it achieves risk control and what plan is in
place to work towards Best Practice.
Best Practice is additional to EQR. Best
Practice as defined in this guidance covers
non-mandatory policies and procedures that
aim to further minimise risks to patients; deliver
better patient outcomes; promote and
encourage innovation and choice; and achieve
cost efficiencies.
Best Practice should be considered when
developing local policies and procedures based
on the risk of surgical procedures and available
evidence. Best Practice encompasses
guidance on the whole of the decontamination
cycle, including, for example, improved
instrument management, where there is
evidence that these procedures will contribute
to improved clinical outcomes.

The HTM 01 suite is listed below.

HTM 01-01: Management and
decontamination of surgical instruments
(medical devices) used in acute care
HTM 01-04: Decontamination of linen for
health and social care
HTM 01-05: Decontamination in primary
care dental practices [check title]
HTM 01-06: Decontamination of flexible
endoscopes.
Note
This guidance remains a work in progress
which will be updated as additional evidence
becomes available; each iteration of the
guidance is designed to help to
incrementally reduce the risk of crossinfection.

HTM 01-01: Management and decontamination of surgical instruments: Part B Common elements

Abbreviations

ACDP-TSE [Subgroup]: Advisory Committee on

Dangerous Pathogens Transmissible
Spongiform Encephalopathies [Subgroup]

EN: European norm

ACDST: Advisory Committee on

Decontamination Science and Technology

ISO: International Standards Organisation

AE(D): Authorising Engineer (Decontamination)

AP(D): Authorised Person (Decontamination)

FITC: fluorescein isothiocyanate

MDD: Medical Devices Directive

MDR: Medical Devices Regulations

BCH: Birmingham Childrens Hospital

MHRA: Medicines and Healthcare products

Regulatory Agency

BS: British Standard

NDS: National Decontamination Survey

BSE: Bovine Spongiform Encephalopathy

NICE: National Institute for Health and Clinical

Excellence

CFPP: Choice Framework for local Policy and

Procedures
CJD: Creutzfeldt-Jakob disease
CMO: Chief Medical Officer
CP(D): Competent Person (Decontamination)
CQC: Care Quality Commission
DH: Department of Health
DIPC: Director of Infection Prevention and
Control

NICE IPG 196 (2006): NICEs (2006)

interventional procedure guidance 196
Patient safety and reduction of risk of
transmission of CreutzfeldtJakob disease
(CJD) via interventional procedures
OPA/NAC:
o-phthalaldehyde/N-acetyl-L-cysteine
PO: posterior ophthalmic
sCJD: sporadic Creutzfeldt-Jakob disease
SSD: sterile services department

EDIC: episcopic differential interference

contrast

TSEs: transmissible spongiform

encephalopathies

EDIC/EF: episcopic differential interference

contrast/epifluorescence

UCHL: University College Hospital London

EFSCAN: epifluorescent surface scanner

vi

vCJD: variant Creutzfeldt-Jakob disease

Executive summary

Health Technical Memorandum (HTM) 01-01

offers best practice guidance on the whole
decontamination cycle including the
management and decontamination of surgical
instruments used in acute care.
Part A covers the policy, management
approach and choices available in the
formulation of a locally developed, riskcontrolled operational environment.
The technical concepts are based on European
(EN), International (ISO) and British (BS)
Standards used alongside policy and broad
guidance. In addition to the prevention of
transmission of conventional pathogens,
precautionary policies in respect of human
prion diseases including variant CreutzfeldtJakob disease (vCJD) are clearly stated. Advice
is also given on surgical instrument
management related to surgical care
efficiencies and contingency against
perioperative non-availability of instruments.
Part B covers common elements that apply to
all methods of surgical instrument reprocessing
such as:
test equipment and materials
design and pre-purchase considerations
validation and verification.
Part C covers standards and guidance on
steam sterilization.

Part D covers standards and guidance on

washer-disinfectors.
Part E covers low temperature (non-steam)
sterilization processes (such as the use of
vapourised hydrogen peroxide gas plasmas
and ethylene oxide exposure).
HTM 01-01 Part B 2016 supersedes all
previous versions of CFPP 01-01 Part B.

Why has the guidance been

updated?
HTM 01-01 has been updated to take account
of recent changes to the ACDP TSE
Subgroups general principles of
decontamination (Annex C). In relation to the
decontamination of surgical instruments, this
principally relates to paragraphs C21 and C22:
Protein detection
C21. Work commissioned by the Department of Health
indicates the upper limit of acceptable protein
contamination after processing is 5g BSA equivalent per
instrument side. A lower level is necessary for
neurosurgical instruments.
C22. It is necessary to use protein detection methods to
check for the efficient removal of protein from surgical
instruments after processing. Protein levels are used as an
indication of the amount of prion protein contamination.
Ninhydrin swab kits are commonly used for this purpose,
but recent evidence shows that ninhydrin is insensitive.
Furthermore, proteins are poorly desorbed from
instruments by swabbing. Other commonly used methods
have also been shown to be insensitive.

vii

HTM 01-01: Management and decontamination of surgical instruments: Part B Common elements

The ACDP TSE subgroups guidance

requires that there should be 5 g of
protein in situ on the side of any instrument
tested. The rationale for each of these
elements is as follows:
The figure of 5 g of protein has been
shown to be achievable by effective
cleaning processes. There is currently no
definitive evidence base to link this with
the absence of prion transmission risk,
which is why lower levels for instruments
making contact with high risk tissues (see
ACDP TSEs Annex J) is necessary.
The measurement is per side of
instrument rather than per unit area of an
instrument. Prion proteins have been
shown to be infectious by contact (Kirby et
al 2012). Infection transmission would be
related to the total area of an instrument
that makes contact with patient tissues.
Thus, while not a perfect relationship, the
assessment of protein levels per side of an
instrument is likely to be a greater
predictor of risk control than an
assessment based on a unit area of an
instrument.
Protein levels on an instrument should be
measured directly on the surface rather
than by swabbing or elution (see the
ACDP-TSE Subgroups Annex C
paragraph C23), as detection of proteins
on the surface of an instrument gives a
more appropriate indication of cleaning
efficacy related to prion risk (see Table C2
in ACDP TSEs Annex C). As technologies
become available that are able to detect
residual protein in situ to 5 g per
instrument side, they should be adopted.
Prion proteins are very hydrophobic and
will, once dry, adhere strongly to surfaces
and resist removal by swabbing or elution
for the purpose of protein detection.

viii

What SSDs can do to ensure

implementation of the ACDP TSEs
Subgroups recommendations
Because of the risks of prion transmission,
there is a need to optimise the whole of the
decontamination pathway of surgical
instruments.
Reducing the time from close of procedure
to reprocessing
Prions are easier to remove if they have not
dried on the surface of an instrument. To
enable efficient prion removal, theatre and SSD
staff should ensure that instruments are
transported to the SSD immediately after the
close of the procedure, for cleaning and
reprocessing as soon as practically possible.
This will make the cleaning process more
effective, hence reducing the risks to the
patients and staff handling the devices. If
devices cannot be returned in a timely manner,
it is important that the instruments are kept
moist using appropriate methods approved and
verified by the SSD.
Cleaning validation and continuous
monitoring
Traditionally, cleaning validation has been about
removing visible soiling. Now the emphasis is
on removing highly adherent proteins to very
low levels. To be able have a greater chance of
removing these sticky proteins, there needs to
be as efficient a cleaning process as possible
therefore SSDs need to both optimise the
cleaning performance of washer-disinfectors
and remain within the validation parameters.
It is important to continuously monitor the
residual protein on reprocessed instruments.
SSDs should not view the 5 g limit as a single
pass or fail, but rather use it as a way of
working towards and below this value, that is,
as part of trend analysis and a quality
assurance system whose aim is to monitor not
just the cleaning efficacy of washer-disinfectors
but also the instrument journey leading up to
that stage in other words, ensuring results are

being monitored and actions are being taken

based on these results. SSDs should include:
daily testing using process challenge
devices* (along with the standard periodic
tests);
quarterly residual protein testing (see
paragraphs 2.2712.278 in HTM 01-01
Part D Validation and verification).
See also Appendix B in HTM 01-01 Part
A for example sampling rates.
Priority should be given to instruments used on
high-prion-risk tissues as defined by ACDP (see
ACDP TSEs Annex J).
* Commercial process challenge devices are
being developed whose challenge simulates
the attachment of prion protein to
instruments and whose analysis is
quantitative. When these become available
and have been validated, SSDs are advised
to consider their use in addition to process
challenge devices based on soils in BS EN
15883-5 Annex N.
Results from the quarterly residual protein test
should be used to analyse trends and act on
that analysis.
Methods for detecting residual protein
SSDs should no longer rely on elution or
swabbing to detect residual protein on an
instrument. The method should be validated as
being able to detect protein equivalent to
5g of BSA in situ on the surface of an
instrument. Commercial technologies that can
detect the 5g limit in situ are being
developed (see ACDP TSEs Annex C). Devices
to detect residual protein must be CE-marked
as an accessory to a medical device (see the
MHRAs Managing medical devices: guidance
for healthcare and social services
organisations and also Medical devices:
conformity assessment and the CE mark.

Residual protein detection devices should

be intended by their manufacturer to be
used as an accessory to a surgical
instrument that has undergone a cycle
through a washer-disinfector validated to BS
EN ISO 15883 Parts 1 and 2 for washing
and disinfecting of surgical invasive devices
and be capable of measuring and detecting
residual protein in situ to levels of 5 g per
side of used, washed surgical instruments.
The manufacturer will need to have CEmarked the product under the Medical
Devices Regulations and issued a
declaration of conformity to demonstrate
that the device has met all relevant essential
requirements for the medical device and that
they have followed an appropriate
conformity assessment route.
Until such time as these are available
as medical devices, residual protein
control relies mainly on controlling the
decontamination process rather than
on protein detection from instruments
that is, process control makes more
of a contribution than product control.
When high resolution methods of
detecting residual protein in situ are
available, then product control should
be used to inform process control.
Continuous improvement plans
SSDs should have in place a plan of continuous
process improvement. This plan should be
carried out as part of a risk management plan
(see BS EN ISO 14971 on medical device risk
management). There should also be a specific
record that relates to residual protein trend
analysis.

Major change to Part B since the

2013 edition
CFPP 01-01 has reverted to the Health
Technical Memorandum title format and
now becomes Health Technical
Memorandum 01-01.
ix

HTM 01-01: Management and decontamination of surgical instruments: Part B Common elements

Acknowledgements

Andrew Bent Medicines & Healthcare products Regulatory Agenc

Anita C. Jones University of Edinburgh
Bill Keevil University of Southampton
Brian Kirk IHEEM Decontamination Technology Platform
Clive Powell Association of British Healthcare Industries
David Perrett Queen Mary University of London
Geoff Sjogren Institute of Decontamination Sciences
Geoffrey L. Ridgway, OBE, MD Clinical Microbiologist
Gerry McDonnell Association of British Healthcare Industries
Graham Stanton NHS Wales Shared Services Partnership Facilities Services
Helen Griffiths Joint Advisory Group on gastrointestinal endoscopy (JAG)
Jackie Duggan Public Health England
James Ironside University of Edinburgh
Jimmy Walker Public Health England
John Singh Health Estates, Northern Ireland
Karen Chell NHS Supply Chain
Katy Sinka Public Health England
Mike Painter Public Health Physician
Mike Simmons Public Health Wales
Miles Allison British Society of Gastroenterology
Peter Hoffman Public Health England
Robert Kingston IHEEM Decontamination Technology Platform
Rod Herve University of Southampton
Sulisti Holmes Health Protection Scotland
Tony Young Southend University Hospital NHS Foundation Trust
Tracy Coates Association for Perioperative Practice

Contents

Preface iv
Abbreviations vi
Executive summary vii
Acknowledgementsx
1 Introduction1
2 Decontamination equipment: test equipment and materials2
3 Design and pre-purchase considerations 10
4 Validation and verification20
References34

xi

1 Introduction

1 Introduction

1.1 Potential purchasers of reprocessing

equipment should ensure that they know
whether the load items they intend to
decontaminate are classified as medical
devices.

1.3 Guidance on the application of medical

devices legislation is beyond the scope of this
guidance, and advice should be sought from
the Medicines and Healthcare products
Regulatory Agency (MHRA).

Medical devices

Definitions

1.2 This guidance covers the various types of

decontamination equipment to be used for the
reprocessing of medical devices (for example
porous load sterilizers, and washer-disinfectors).

1.4 For definitions of terms used in this

guidance, see ISO 11139:2006 Sterilization of
health care products vocabulary.

HTM 01-01: Management and decontamination of surgical instruments: Part B Common elements

2 Decontamination equipment: test equipment

and materials

Refer to the Particular specifications for

sterilizers (see page 72 in HTM 01-01 Part
C) and washer-disinfectors (see page 77 in
HTM 01-01 Part D).

General considerations
2.1 This chapter reviews the key items of
portable test equipment necessary to carry out
the test procedures described in this guidance.
Specifications for instruments fitted
permanently to decontamination equipment are
given in the relevant British, European and
International Standards.
2.2 Instrumentation technology continues to
advance rapidly, making it increasingly difficult
and undesirable to provide detailed
specifications for the equipment to be used in
testing equipment. There is a clear trend
towards computer-controlled data recorders
with software, which enables the system to
verify attainment of the required conditions and
then to produce a detailed written report
accompanied by tabulated or graphed data.
Although these new systems may offer
advantages in clarity of presentation, as well as
reduced operator time, the traditional
instruments, such as chart recorders, remain
equally acceptable where they meet the
accuracy defined in this section.

Note
Retention of data for long-term use is
important. Where modern technology/
datarecording equipment is used, it should
be equipped with memory devices that
enable data to be retrieved at a later date.
Traditional chart recorders allow the retention
of the chart for long-term storage and followup.
2.3 The objectives of this section are both to
ensure that traditional measurement methods
are supported adequately and to define clearly
the essential requirements that apply to the test
equipment whether it is a traditional system or
the latest technology.
2.4 When it is proposed to use measurement
and/or recording techniques that are not
covered in this guidance, the advice of the
Authorising Engineer (Decontamination) should
be sought.
2.5 All test equipment should be calibrated by
a UKAS-accredited laboratory in accordance
with ISO/IEC 17025, with traceability to the
National Standard.

Calibration and sources of error

2.6 Errors of measurement occur for a number
of reasons. These include inherent factors such
as the design of the measuring equipment,
common problems with sensors (such as loose
or imperfect connections), damaged insulation,

2 Decontamination equipment: test equipment and materials

and broken conductors, combined with

changes in the environmental temperature
around the instrument. Variations in the sensors
themselves, the method of introducing the
sensors into the machine and their location
within the load may add to the error in the
temperature measurement. Changes in
conditions other than the one being sensed
may also lead to errors, for example
temperature fluctuations within pressuresensing elements may lead to errors in pressure
measurement.
2.7 Careful attention to detail including the
location of the test instruments, effective
maintenance and the skill of personnel trained
in the application, handling and use of the
instruments are required to eliminate or
minimise these errors. Systematic errors can be
reduced by careful calibration.
2.8 Instruments should be subject to a
planned maintenance and calibration
programme, in accordance with the instrument
manufacturers recommendations, occurring at
least annually. Each instrument should be
labelled with a calibration date and a reference
from which its current calibration status may be
traced.
2.9 Instrument calibration should be carried
out in accordance with the instrument
manufacturers instructions by a validated
method, using a reference standard of suitable
accuracy that has been certified within the
previous 12 months by a UKAS test laboratory.
The calibration laboratory should be instructed
to adjust the instrument under test to read true
values, and to report before and after
calibration results so that instrument drift can
be monitored. A full history record, including all
maintenance and calibration details, should be
kept for each instrument.
2.10 The instrument should have a valid test
certificate and the calibration data should
include a temperature within the process
temperature band.

2.11 In use, all test instruments should be

located in a position protected from draughts
and not subjected to rapid temperature
variations. Test instruments should be allowed a
period of time to stabilise within the
environment of the test site. The manufacturers
instructions should be followed.

Data recorders
2.12 Test recorders are required to measure
temperature in all types of decontamination
equipment and may also be required for the
measurement of pressure, flow rates, and other
critical parameters. They should be designed
for use with the appropriate sensors,
independent of those fitted to the machine.
2.13 Sufficient connections to meet the testing
requirements of the relevant HTM and EN
standard should be provided.
2.14 Recorders should comply with the
requirements of BS EN 285 or BS EN ISO
15883.
2.15 Data from digital recorders (dataloggers)
can be presented graphically or as a listing of
numerical values, or as a combination of both.
In many cases, parts of the operating cycle can
be expanded and replotted for closer
examination.
2.16 Digital recorders should have the facility to
record data immediately that can then be
removed for secure storage. Alternatively, the
recorder may be connected to a central
computer and the data recorded to the hard
drive. Software used with digital recorders
should be developed and validated under a
recognised quality system (see BS EN ISO
13485).
2.17 The detailed specification for a test
recorder will depend upon the range of
equipment with which it is to be used. The
measurement system (recorder and sensors)
should be capable of measuring cycle variables
to the required accuracy of the instruments
fitted to the machine.
3

HTM 01-01: Management and decontamination of surgical instruments: Part B Common elements

2.18 The accuracy with which a variable can be

read from the recorder will be affected not only
by the sources of error discussed above but
also by the precision of the calibration, the
scale range, the integration time, the sampling
interval and the intrinsic accuracy of the
recorder. Digital instruments might display
measured values with a greater level of
discrimination than the accuracy of the system
as a whole: care needs to be taken with the
configuration of outputs and the interpretation
of the measured values.
2.19 The accuracies quoted by recorder
manufacturers are measured under controlled
reference conditions and do not include the
errors from connected sensors. Temperature
measurement errors due to ambient
temperature changes should not exceed
0.04C per C rise. The system should be
calibrated as a whole also.
2.20 The scale ranges should include the
expected maximum and minimum values of the
cycle variables throughout the operating cycle,
with sufficient leeway to accommodate any
deviations resulting from a malfunctioning
machine.
2.21 At all stages of the cycle, the values of the
variables are critical and the recorder should be
capable of measuring them to sufficient
accuracy to confirm that the process conditions
have been attained. The criteria are as follows:
a. For digital recorders, the sampling interval
should be short enough for the holding
time to contain at least 180 independent
measurements in each recording
channel. This corresponds to a sampling
interval of one second for the shortest
holding time (three minutes, hightemperature steam sterilizers) for periodic
testing. For pen recorders, the chart
speed should be fast enough to allow
fluctuations on that scale to be clearly
resolved. The duration of the holding time
should be measurable to within 1%.
b. The integration time of the recorder (the
response time) should be short enough
4

to enable the output to follow significant

fluctuations in the cycle variables and to
ensure that successive measurements
are independent of each other. It should
not be longer than the sampling interval.
c. The recorder should be accurate enough
to show clearly whether the measured
temperatures are within the band or not.
For all the types of equipment covered by
this guidance, the repeatability of the
recorder should be 0.25C or better,
and the limit of error of the complete
measurement system (including sensors)
should be no more than 0.5C.
d. For pressure measurement, the limit of
error should be no more than 0.5% of the
absolute pressure during the plateau
period.
e. Attention should also be paid to the
accuracy of the time base of the
recording system, particularly on longer
cycles where any error will become more
obvious. This can be by means of a
calibrated stopwatch against a calibrated
time signal (for example the BT speaking
clock).
2.22 The scale range for each variable to be
measured should be optimised to cover all
values occurring during the process. As well as
having calibration certificates for each item of
the measuring chain, the complete system
should be calibrated in the working environment
(for example the sterile services department).

Temperature measurement
Temperature sensors
2.23 Temperature sensors should be used to
sense the temperature in locations specified in
the tests described in this guidance. The
sensors should be either platinum resistance
elements and comply with class A of BS EN
60751 or thermocouples and comply with
Tolerance Class 1 of BS EN 60584-2 and have
a response time in water of t90 0.5 seconds.

2 Decontamination equipment: test equipment and materials

Other sensors of demonstrated equivalence

can be used.

watertight or gas-tight seal, are equally

acceptable.

2.24 Thermocouple wire should be singlestrand, not exceeding 0.7 mm diameter over
the covering of one core of a twin cable. The
width of the cable should not exceed 2 mm. If
bulkier cable is used, the tracking of steam
along the outside of the cable may invalidate
certain tests, such as those which require
temperatures to be measured in the centre of a
standard test pack (the standard test pack is
described in BS EN 285).

2.29 All reporting software should be validated,

backed-up (with backed-up data being kept in
a secure location off-site) and secure to ensure
no unauthorised access.

2.25 Thermocouples may be argon arc-welded

or micro-welded. However, experience has
shown that, provided the wires are cleaned,
they may be satisfactorily twisted together to
form the hot junction. Brazing, silver brazing
and welding with filler rods may be no more
reliable in respect of accuracy than freshly
twisted wires. Thermocouples should not be
fitted with a heat sink.

Instrument verification

2.26 The performance characteristics of the

temperature sensor should not be adversely
affected by the environment in which it is
placed, for example pressure, hot detergent
solution etc. Certain environments in which
thermocouples may be used may be corrosive
to certain metals. Thermocouple junctions
should be regularly inspected for corrosion and
remade and recalibrated as necessary.
Thermometric recording instrument(s)
2.27 Thermometric recording instruments
should be used in conjunction with the
temperature sensors to record the
temperatures measured in the locations
specified in the tests described in this
guidance.
2.28 Guidance on test apparatus designed to
introduce thermometric measuring equipment
into the sterilizer chamber and washerdisinfector chamber is provided in BS EN 285
and BS EN 15883 Parts 1 and 2 respectively.
Other methods of introducing temperature
sensors into a chamber, which guarantee a

Use of sensors
2.30 Guidance on use of sensors for sterilizers
and WDs is provided in BS EN 285 and BS EN
15883 Parts 1 and 2.

2.31 Before and after each series of tests on

any item of decontamination equipment, the
measured temperature recording system
should be verified by comparison with an
independent reference temperature source at
the process temperatures.
2.32 The temperature measured by all
temperature sensors when immersed in a
temperature source at a temperature known
within 0.1 K and within the process
temperature band should not differ by more
than 0.5 K. The reference instrument(s) used on
site as the recording system should be
calibrated and/or adjusted in a controlled
environment or laboratory with relevant UKAS
traceable certification and laboratory
references. Before and after each series of tests
on any item or items of decontamination
equipment the measured temperaturerecording system should be verified by
comparison with an independent reference
temperature source at the required process
temperatures. The comparison instrument
used, such as a digital thermometer, should be
traceable to UKAS calibration standards. No
adjustment to the test instrumentation should
be made on site in an uncontrolled environment
unless the test contractor or organisation holds
a UKAS site calibration procedure and
certification that includes adjustment which
should be available for inspection or audit. Any
adjustments made to test instrumentation
should be logged and included within the test
report.
5

HTM 01-01: Management and decontamination of surgical instruments: Part B Common elements

Self-contained systems
2.33 Where it is impractical to insert sensor
leads into processing equipment, self-contained
datalogging devices may be used.
2.34 A number of different designs of small selfcontained single channel data loggers for the
measurement of temperature are commercially
available. They are independently powered,
may be programmed to take readings at the
required rate for the required duration, and are
downloaded onto a computer on completion of
the datalogging period.
2.35 Care needs to be taken in selecting units
that are capable of withstanding the high
temperatures found in sterilizers and washerdisinfectors.
2.36 The accuracy, resolution and sampling rate
requirements should be identical to those
specified for conventional recorders (see
Chapter 4, Validation and verification).
2.37 Where two or more dataloggers are used
together on the same process, the time bases
of the instruments should be synchronised.

Pressure measurement
Measurement ranges
2.38 Pressure measurement ranges for WDs
should be up to 1000 kPa (10 barA) (for
example for the water supply pressure).
Differential pressures of 0.1 to 10 kPa ( 100
mbar) may need to be measured (for example
for the determination of the pressure drop
across filters).
2.39 Pressure measurement ranges for steam
sterilizers may be from 3 to 10 kPa (in vacuum
leak testing) to typically 400 kPa at the working
pressure of a high-temperature steam sterilizer.
Sensors and gauges
2.40 Pressure sensors should be used in the
tests described in this guidance and should
conform to BS 6447. The natural frequency of
6

the sensor and connected tubing should be not

less than 10 Hz and the time constant for rising
pressure (0 to 63%) should be not greater than
0.04 seconds.
2.41 The performance characteristics of the
pressure sensor should not be adversely
affected by the environment in which it is
placed (for example temperature, hot detergent
solution etc). Certain environments in which
sensors may be used may be corrosive to
certain materials. Compatibility should be
confirmed with manufacturers instructions.
2.42 The requirements for gauges required for
testing decontamination equipment are shown
in Table 1.
2.43 Pressure gauges should be temperaturecompensated and, except for the differential
pressure gauge, be Bourdon-tube gauges
conforming to BS EN 837-1 of nominal size 150
mm and accuracy class 0.25 (that is, the error
should not exceed 0.25% of full scale
deflection).
Table 1 Requirements for pressure measurement
Scale range

Mark
interval

Calibration

Application

0 to 16 kPa

0.1 kPa

Gas

Vacuum leak-testing

0 to 100 kPa

1 kPa

Liquid

Differential pressure
across water filters

0 to 500 kPa

5 kPa

Liquid

Steam sterilizers

0 to 1000 kPa

5 kPa

Liquid

Water supply
pressure.
Recirculating pump
pressure

0 to 50 kPa

1 kPa

Air

Differential pressure
across air filter

2.44 Gauges not designed for direct connection

to steam at 380 kPa (2.8 bar) should be
connected via a siphon or similar device to
ensure that the accuracy of the gauge is
maintained over the temperature range
associated with changing steam pressure. If the
low-pressure gauge used for vacuum leak
testing cannot withstand the pressure in the
chamber during sterilization, an automatic valve
should be provided to protect it.

2 Decontamination equipment: test equipment and materials

Flow measurement
Water
2.45 The volume of water used for each stage
of the operating cycle may be measured using
a water meter complying with ISO 4064-1 Class
A.
2.46 The meter should be designed to operate
at temperatures up to 90C with a supply
pressure up to 1700 kPa (16 bar).
2.47 The meter should have a minimum scale
division of 0.1 L or less and be designed to
measure flow rates over the range 1 L/min to
25 L/min.
2.48 A single jet turbine system is sufficiently
accurate for the purpose. Other systems such
as multi-jet turbine or semi-positive
displacement systems complying with ISO
4064-1 Class B or Class C may also be used.
2.49 The calibration of the flow meter should be
verified by comparing the indicated flow rate
with a measured volume collected over a
measured time period. The collected volume of
liquid may be determined by either gravimetric
or volumetric measurement. The gravimetric
method is generally more accurate as the
temperature of the liquid increases.
Chemical additives
2.50 The volume of chemical additive used for
each stage of the operating cycle may be
measured using a flow meter. A number of
commercially available flow sensors designed
to monitor flows in the range 0 to 2 L/min are
suitable for interfacing to a recorder or
datalogger.
2.51 The sensor should be suitable for use with
fluids having viscosity in the range 0.8 to 20
centiStokes and should be calibrated for the
viscosity of the fluid to be measured.
2.52 The sensor should be designed to operate
at temperatures up to 70C with a supply
pressure up to 1100 kPa (10 bar).

2.53 The meter/recorder should have a

minimum scale division of 10 mL or less and be
designed to measure flow rates over the range
50 mL/min to 1500 mL/min.
2.54 The system should have an accuracy of
2.5% of full scale or better.
2.55 The calibration of the meter should be
verified by determining the indicated volume
flowing to a collecting vessel and comparing
this with the collected volume determined by
gravimetric or volumetric measurement.

Note 1
When the meter is connected in the pipe
there will be a noticeable pressure drop
across the meter. Although this should be
less than 1 bar it may interfere with the
normal operation of the washer-disinfector
and therefore should not be used during
tests for other characteristics than the volume
of water used.

Note 2
A meter of the rotating vane type calibrated
using water at 20C as the flowing medium
and then subsequently used to measure the
flow of a detergent solution with a viscosity of
30 centiStokes would have an error of 15
20% if no correction was applied.

Volume measurement
2.56 The volume of chemical additives and the
volume of water used in each stage are critical
variables in the control of the washingdisinfecting process.
2.57 The volume used may be measured
directly by collection in a graduated vessel of
appropriate size.
2.58 Alternatively, for liquids of known density,
the volume may be determined by collection in
an appropriate size vessel of known mass
(empty), determination of the mass of the vessel
7

HTM 01-01: Management and decontamination of surgical instruments: Part B Common elements

and contents, calculation of the mass of the

liquid and hence (by dividing this volume by the
density) calculating the volume of liquid.

2.65 A balance is also required for weighing the

standard textile test pack (7 kg) and the metal
load (1520kg) to a 10 g resolution.

2.59 Whichever method is used, the accuracy

should be such that the error is less than 2%.

Gas-monitoring equipment

2.60 Volumetric measuring containers

complying with BS 5898, ISO 384 are suitable.

Other instruments
Sound level meter
2.61 An integrating sound level meter is
required for the sound pressure test. It should
comply with Type 2 of BS EN 61672-1 and BS
EN 61672-2. Ten microphones are required for
the test on a single piece of equipment.
Airflow metering device
2.62 A metering device (such as a needle valve)
is required to admit air into the sterilizer
chamber for the air detector tests, and vacuum
and pressure leak tests. The device should be
capable of controlling the flow of air into an
evacuated chamber. It should be adjustable
and have a range that includes a flow of 05
mL/ min per litre volume of the sterilizer
chamber. The error in repeatability between
10% and 90% of the setting range should not
exceed 5%. The device is connected to the
chamber by a valved port provided by the
sterilizer manufacturer.
Balance
2.63 A laboratory balance is required for steam
dryness tests, load dryness tests, calibration of
flow meters (for measuring the flow of water
and/or chemical additives) and coolant quality
tests. It should be capable of measuring the
mass of loads up to 4 kg to an accuracy of 0.1
g and up to 400 g to an accuracy of 0.01 g.
2.64 An analytical balance is required for
determination of the TDS (evaporative residue)
in feed water. It should be capable of
measuring a mass of up to 100g with an
accuracy of 0.1 mg.
8

2.66 A gas-monitoring instrument is required for

tests on equipment using chemical additives
that have a significant vapour pressure and are
a potential risk.
2.67 The nature of the instrument will depend
on the substance to be monitored. In case of
doubt, advice should be sought from the
manufacturer of the chemical additive or the
AE(D).
2.68 The scale range of the measuring
instrument should include the appropriate
short-term exposure limit or occupational
exposure limit and extend to at least ten times
that exposure limit.
Aerosol generator
2.69 An aerosol generator is required for tests
on machines incorporating air filters intended to
deliver air free from microorganisms.
2.70 The device should be capable of
generating a polydisperse aerosol with particles
having the size distribution shown in Table 2
below.
Particle-counting photometer
2.71 A particle counter is required for tests on
machines incorporating air filters intended to
deliver air free from microorganisms. The
device should be suitable for estimation or
comparison of the mass concentration of
airborne particles as defined in Table 2.
Table 2 Particle size distribution for aerosol generator
Particle size [m]

Fraction % by mass

<0.5

>20

<0.7

>50

<1.0

>75

Source : BS EN ISO 14644-1

2 Decontamination equipment: test equipment and materials

2.72 It should have an accuracy of better than

5% over the range of a five expandable, sixdecade resolution (that is 0.01% to 100% of the
test cloud) as specified in BS EN ISO 14644-1.
2.73 The photometer should have a minimum
threshold sensitivity of 0.0001 g/L and should

be capable of measuring aerosol concentration

in the range 80 to 120 g/L.
2.74 The sampling flow rate should be 0.40
0.05 L/s and sampling should be via a suitable
probe.

HTM 01-01: Management and decontamination of surgical instruments: Part B Common elements

3 Design and pre-purchase considerations

3.1 This chapter of the guidance provides

advice on the specification, purchase and
installation equipment used for the
decontamination of surgical instruments in
hospitals, laboratories and other healthcare
facilities.

post-tender analysis;

Pre-purchase considerations

advising on specification qualification,

installation qualification (IQ), operational
qualification (OQ) and PQ.

Introduction
3.2 It is essential that the purchase of an item
of decontamination equipment is planned
correctly. This section aims to help the
purchaser with a step-by-step discussion of the
issues to be included. As this section is
designed to be universally applicable, it might
be necessary to vary the procedure according
to local circumstance or requirements.
Specialist advice
3.3 The efficient completion of procurement
documentation will require advice and help
from a decontamination specialist, for example
an AE(D).
3.4 This assistance should be sought in the
following areas:

10

advising manufacturer/contractor on
validation protocols;
monitoring validation performance;
auditing validation report;

Quality systems
3.5 Adherence to engineering standards and
quality systems ensures that decontamination
equipment is manufactured, installed, validated
and subject to the necessary periodic testing to
establish the initial and then on-going
satisfactory performance of the machine to
ensure optimum decontamination of surgical
instruments and safety of both operators and
patients.
Product listing
3.6 The purchaser should list all load items
proposed and projected to be re-processed by
the decontamination equipment. This should
include the following for each item:

determining initial User requirements;

number;

choosing and completing the relevant

Particular specification (see appendices
in HTM 01-01 Parts C and D);

size;

determining throughput parameters;

temperature sensitivity;

advising on relevant performance

qualification (PQ);

moisture sensitivity;

materials of construction;

pressure-variation sensitivity;

3 Design and pre-purchase considerations

requirements for disassembly;

manufacturers decontamination
instructions;
usage time constraints (to determine
requirements for extra instrumentation
only).
Spatial requirements
3.7 A full assessment of current space
available should be made. It can be that
additional machine numbers will require
additional space. The possibilities should be
considered and checked once a throughput
calculation has been made. The machine
configuration (number of doors etc) can affect
the spatial requirements.
Machine configuration
3.8 Advice on throughput calculations,
equipment number determination, SSD design
and floor suitable areas is given in Health
Building Note 13 Sterile services department.
Protein removal and protein optimisation
3.9 All decontamination equipment should
have the ability to have cycle parameters varied
(for example for washer-disinfectors time,
temperature, number of stages of main wash,
use of different detergents etc) to enable
equipment to have cycles optimised as more
data becomes available on more effective
cycles and chemicals for protein removal (see
Chapter 4, Validation and verification).
Specification preparation
3.10 The use of the Particular specifications
(see HTM 01-01 Parts C and D) will enable data
provided by the tenderer on technical points as
well as financial data to be compared. Not only
will this enable the purchaser to confirm the
acceptability of current services, spatial
requirements and porterage, but also it will
enable a like-for-like tender analysis to be
made. Tender analysis will be best achieved by
formalising tender comparison with respect to
performance and cost in all key areas.

Qualifying statements by the tenderer should

be taken into account. Their effect on tender
content or eligibility should be assessed before
making a choice.
3.11 The specifications allow the purchaser to
define post-validation service or contract work
requirements. A choice on the relevance of
these issues will need to be made prior to
distribution of the procurement documentation.

Procurement of equipment
an overview
Introduction
3.12 This section gives a short overview of the
process of purchasing decontamination
equipment. It refers to more detailed information
in subsequent sections, including information
specific to each type of decontamination
equipment given in subsequent sections.
Purchasing decontamination equipment
3.13 The purchase of decontamination
equipment can be broken down into the
following sequence of steps.
What type of load will be processed?

3.14 A knowledge of the load(s) to be

processed is a prerequisite to make the correct
decision about which piece of equipment to
purchase; the difficulty in obtaining a clean
product, the standard of cleanliness and the
disinfection required vary for different product
types. For example, some products with
intricate interstices or long narrow lumens
require specific provision if they are to be
cleaned satisfactorily.
3.15 Purchasers should specify all items that
may present a challenge to decontamination in
order to allow the tenderer to offer the most
appropriate machine and accessories.
3.16 Manufacturers reprocessing instructions
should be taken account of. Where instructions

11

HTM 01-01: Management and decontamination of surgical instruments: Part B Common elements

are particularly onerous, these should be

included as an annex in the tender document.
What type of machine is required?

3.17 In this guidance, washer-disinfectors are

classified by:
the product range which they are
intended to process;
their configuration and load handling
type;
the nature of the cleaning and disinfection
process.
3.18 Sterilizers are classified as either clinical or
laboratory sterilizers. Clinical sterilizers can use
one of a number of different sterilizing agents
(sterilants): purchasers should give due
consideration to the compatibility of the items to
be processed with the process itself.
Where will the machine be sited?

trained staff whose sole or principal activity

will be the operation of the machine may be
complex. Operators should thus be designated.
Further requirements may be found in BS EN
ISO 13485.
What capacity is required?

3.22 The likely daily and weekly workload, and

the peak hourly workload, that the equipment
will have to process should be established, then
the number of machines required to process
the workload should be calculated. Throughput
figures for different manufacturers machines
and different models within any given range
vary considerably. For continuous process
machines a distinction should be made
between the time required to process one load
and the total number of loads that can be
processed in a period of one hour. Further
guidance is given in Health Building Note 13.
Consideration should be given to the time and
spatial aspects of post-process conditioning.

3.19 The location available for the equipment

will have a significant influence on the type of
machine that can be used. Many of the larger
continuous process machines require
considerable space. Some machines will
require considerable building work.

What ancillary equipment will be needed?

What services are available?

3.24 A washer-disinfector might require ancillary

equipment such as water softeners,
deionization or reverse osmosis (RO) water
treatment plants, steam generators, air
compressors, extract ventilation (with or without
condensers), bulk storage and dispensing
facilities for process chemicals.

3.20 Decontamination equipment will require

several of the following services: steam,
electricity, water, compressed air, drainage,
effluent handling, ventilation and bulk or integral
storage/supply of chemical additives/sterilant
gas supply. The manufacturers data will show
which services are required for each model.
Determine which of these are available at the
proposed site and the capacities of each
service. It might be necessary to plan for a new
service, which would add greatly to the cost of
the installation.
Who will operate the equipment?

3.21 Equipment located in a centralised

processing unit under the care of specially
12

3.23 A sterilizer installation might require

ancillary equipment such as special ventilation
water treatment for steam generators, air
compressors, preconditioning facilities,
degassing facilities and gas disposal plants.

3.25 In addition some machines will require

load staging facilities, before and after
processing, purpose-built load carriers for
different categories of product, and means for
returning load carriers from the unloading side
of the machine back to the loading side.
What standards or specifications are relevant?

3.26 Most items of decontamination equipment

will be constructed to either a BS, EN or ISO

3 Design and pre-purchase considerations

Standard. In some cases additional

specifications will be required.

Choice of equipment

What sort of contract?

3.32 This section contains information relevant

to the choice of new decontamination
equipment. It discusses the types of machine
and the loads for which they are suitable, and
gives guidance on selecting the size and
number of machines required for a given
application.

3.27 Once the specification has been

completed, a contract should be drawn up for
the supply and installation of the machine.
Which manufacturer?

3.28 Three or more manufacturers should be

invited to tender for supplying the
decontamination equipment. While no
manufacturer should be excluded unnecessarily
from the tendering process, they should not be
invited to tender unless there is a realistic
prospect of their being awarded the contract.
What installation and commissioning arrangements?

3.29 After delivery and installation, the

decontamination equipment should be
subjected to a formal documented programme
of validation.
What arrangements for service and repair?

3.30 It is common practice for the initial

purchase contract to include all service and
repair costs for the first year after installation,
that is, during the warranty period. A number of
manufacturers also offer an extended warranty
facility that, sometimes for an additional fee,
provides an all-inclusive service and repair
option.
What are the likely running costs?

3.31 Advice should be sought at the time of

tender on the operational costs of the various
machines that would be suitable. The
operational costs should include the anticipated
requirements for services (water, electricity,
steam etc), consumable items (detergents, rinse
aids etc) and maintenance. This data should be
used in the evaluation of the tender bids.

Introduction

Choice of equipment
3.33 The choice of machine should be
governed by the nature of the loads to be
reprocessed. Detailed guidance on appropriate
processes for different load items can be
obtained from the manufacturers of the medical
devices.
Sizes and numbers
3.34 Precise information on the sizes and
numbers of machines required for particular
applications is difficult to give since there are
considerable variations in patterns of use. The
number of machines required will depend on
the cycle time and the loading capacity of the
machine and in some circumstances on the
flexibility of operation that might be required, for
example whether items to be processed can
wait until there is a full load for the
decontamination equipment or need to be
processed immediately.
3.35 Consideration should be given to
contingency plans for machine usage, and
sufficient time should be included for testing,
maintenance and service. Thus reliance on a
single item of equipment is not advisable.

Specification and contract

3.36 This section discusses general
specifications for decontamination equipment
and the steps to be taken to invite tenders and
issue a contract. Specific advice for sterilizers
can be found in HTM 01-01 Part C and for
washer-disinfectors in HTM 01-01 Part D.

13

HTM 01-01: Management and decontamination of surgical instruments: Part B Common elements

Preparing a specification
3.37 Purchasers should seek assistance from
the AE(D) when preparing a specification for
decontamination equipment.
3.38 Standards and other specification
documents are continually being updated, and
purchasers should ensure that they consult the
latest editions of such documents, including
any amendments issued after publication, to
keep abreast of changing requirements. Advice
should be sought from the AE(D).
General design considerations
3.39 The following design considerations are
applicable to all or most types of
decontamination equipment, but are not
necessarily required by the current Standards.
Where applicable they should be included in
the specification for any decontamination
equipment to be operated in the healthcare
sector.
3.40 All decontamination equipment and
associated equipment is classed as work
equipment and should comply with the
Provision and Use of Work Equipment
Regulations 1998 (amended 2002 by the Health
and Safety (Miscellaneous Amendments)
Regulations). Purchasers are reminded that
under the Regulations it is the responsibility of
the employer, not the manufacturer, to provide
decontamination equipment that is suitable for
the purpose for which it is used or provided.
Further information is available in HTM 01-01
Part A.
3.41 All decontamination equipment made or
sold in the UK from 1 January 1996 must
conform to the emission and immunity
requirements of the current Electromagnetic
Compatibility Regulations 2005. This may be
achieved by compliance with BS EN 61000-6-3
(emission) and BS EN 61000-6-1 (immunity).
The manufacturer should be informed of any
local sources of electromagnetic disturbance
that could affect the operation of the machine.

14

3.42 For maintenance purposes, one or more

panels of free-standing WDs, and side, back
and top panels on sterilizers, should be easily
removable and replaceable. Pressure regimes
should not be affected by this.
Safety features
3.43 Safety features should be designed in
accordance with the British Standard code of
practice for safety of machinery, PD 5304, and
the European Standards for the safety of
electrical equipment, BS EN 61010-1 and BS
EN 61010-2-040.
3.44 The design of the control system should
ensure that the door cannot be opened until
the cycle is complete. When a fault is indicated
the door should only be able to be opened by a
key code or tool, when the equipment is
returned to a safe condition.
3.45 Steam sterilizers should conform to the
requirements listed under Safeguards and
Interlocking in HSE Guidance Note PM73
Safety at autoclaves.
3.46 The manufacturer should provide a list of
all safety devices together with their settings
and methods of adjustment.
3.47 All safety devices should be designed to
fail in a manner that does not cause a safety
hazard to personnel.
3.48 Any error in the control or indication
system should not cause a safety hazard.
Instrumentation
3.49 Where an instrument can be adjusted the
adjustment should require the use of a key
code or tool that is not available to the
Operator.
3.50 Where a fault is indicated as an error
message shown on a visual display unit, it
should be clearly distinguishable from normal
messages, for example by use of a different
colour or larger size of text. The indication

3 Design and pre-purchase considerations

should remain displayed until acknowledged by

the Operator.

memory. The version number of the software

should be available for display when required.

3.51 Where required within the specification,

the Contractor should be required to carry out
adjustments to the instruments on site so that
the accuracies specified at the sterilization
temperature can be met with the plant running
and under the conditions normally prevailing on
site.

3.57 Combined control and instrumentation

systems that are wholly operated by means of
PES should incorporate at least two timing
systems, independent of each other, such that
the timer used to control the holding time is
verified by the other timer.

3.52 There should be an indicator that shows

which stage of the operating cycle is in
progress and indicates cycle complete at the
end of the cycle. For continuous process WDs,
separate indication of the operational status
should be provided for each chamber or
section.
3.53 A counter with a minimum of five digits
should be provided to indicate the cumulative
total of cycles started. The counter should be
tamper-evident or sealed. For continuous
process WDs the counter should indicate the
number of loads that have entered the machine.
3.54 For pressure or flow testing, test tees and
valve cocks with sealing plugs should be fitted
to permit connection of test instruments for the
verification and calibration of all instruments
permanently fitted to the machine. The
connection should be as described in BS EN
285.
Programmable electronic systems
3.55 Modern decontamination equipment
frequently uses programmable electronic
systems (PES) for control and data recording.
Where such systems are used, they should be
designed in accordance with the principles set
out in the HSE document Programmable
electronic systems in safety related
applications.
3.56 Where a PES is used for control or
monitoring of the process, the values of cycle
variables critical to process performance and
determined during validation should be
documented in the validation report regardless
of whether or not they are held in the PES

Doors
3.58 The choice of design for any particular
installation will depend on the workload, space
restrictions, price and ease of maintenance.
With hinged doors there is a risk of the
Operator touching the hot inside face as the
door is opened. If hinged doors are required,
the specification should state whether they are
to be hinged on the left-hand or right-hand side
or top or bottom of the opening. Where sliding
doors are incorporated, the direction of opening
should be specified. The method of door
opening will impact on load handling equipment
design, the method of loading and unloading,
the height of the chamber above floor level, and
manual handling issues.
3.59 It should be possible to clean the contact
surfaces of the door seal without removing
parts of the machine.
Invitation to tender
3.60 Once detailed specifications have been
drawn up, manufacturers should be invited to
tender for the supply and, if required, the
installation of the decontamination equipment.
3.61 Prospective contractors should be given
the following information:
a. that each machine will be subject to a
validation process as described in the
validation and verification section (see
Chapter 4, Validation and verification);
b. that unless otherwise specified, the
installation checks and tests specified in
the validation process should be
satisfactorily completed before the
machine can be accepted;
15

HTM 01-01: Management and decontamination of surgical instruments: Part B Common elements

c. whether the factory/works tests, site visits

or installation checks and tests are to be
witnessed by the appropriately-qualified
purchasers representative (normally the
AE(D), AP(D) or CP(D));

Delivery

d. the date by which all services will be

available;

3.66 Decontamination equipment for a

particular scheme should not be ordered and
stored on site for long periods prior to
installation and validation. Disregard of this
recommendation can invalidate the
manufacturers warranty and cause
deterioration of the machine prior to installation.
Where a long delay is unavoidable, conditions
for storage should be agreed with the
manufacturer.

e. the date by which the validation process

is expected to be completed.
Contract
NHS Supply Chain has in place a national
framework agreement that covers sterilizers
and washer-disinfectors, water treatment
systems, training, maintenance and
validation. The framework enables
procurement of these products and services
tailored to specific reprocessing needs,
without the need to instigate an OJEU tender
(see link in the References section).
3.62 Consideration may also be given to the
use of alternative forms of contract, for example
MF/1 (available from the Institution of Electrical
Engineers, the Institution of Mechanical
Engineers or the Association of Consulting
Engineers) or the Joint Contracts Tribunal (JCT)
suite of documents (available from RIBA
Publications).
3.63 Purchasers using other forms of contract
are strongly advised to seek legal advice.
Purchasers should not purchase equipment or
services under the suppliers terms and
conditions of contract.
3.64 Where currently not in place, other
contracts, notably for the AE(D), the CP(D), the
CP(PS) and the Microbiologist, may need to be
considered at this time. In awarding these
contracts, purchasers should ensure that there
is no conflict of interest that would compromise
the validation process.

16

3.65 On or before delivery of the machine, the

manufacturer should provide the purchaser with
the information specified in Table 3.

Siting
3.67 A comprehensive review of the
requirements for SSDs is given in Health
Building Note 13 and for operating departments
in Health Building Note 26 Facilities for
surgical procedures.
3.68 The area in which decontamination
equipment is installed should meet the
requirements of the Workplace (Health, Safety
and Welfare) Regulations 1992 amended 2002,
which have far-reaching implications for the
design of decontamination equipment
accommodation and services to be installed.
3.69 Fire safety precautions should comply with
the current Approved Document B of the
Building Regulations and the Firecode series.

Engineering services
Introduction
3.70 Decontamination equipment installation
will require one or more external services
including steam, electricity, hot and cold water,
compressed air, ballast air, drainage, ventilation
and purified water. The manufacturer should
make clear at an early stage which services will
be needed and the detailed requirements for
each, as outlined in Table3.

3 Design and pre-purchase considerations

Table 3 Information on services to be obtained from the manufacturer for sterilizers and washer-disinfectors
Steam

a) acceptable range of supply pressures

b) maximum flow and usage rates
c) usage per operating cycle
d) when steam is generated within the machine, the acceptable limits for hardness, pH and conductivity of feed
water.

Electricity

a) type of supply e.g. AC or DC

b) number of phases (normally one or three) and whether neutral is required for a three-phase supply
c) supply voltage and frequency including nominal and acceptable minimum and maximum values
d) maximum continuous power demand in kW or kVA

Compressed air

a) acceptable range of supply pressures

b) the flow required at minimum pressure
c) the volume of air used for each cycle
d) the quality or quantity of air required including dew point, maximum size and concentration of particulate
material, oil content and microbial contamination level as relevant

Water

For each grade of water required:

a) the acceptable range of supply pressures
b) the flow at minimum pressure
c) the volume used per cycle
d) the acceptable temperature range for incoming water
e) the quality of water required when relevant:

the maximum permissible hardness expressed as mg/CaCO3;
the acceptable range of pH;
the maximum permissible conductivity;
the limiting concentration of heavy metals, halides, phosphates, silicates and nitrates;
the maximum acceptable microbial population.

Drainage

a) the maximum flow of effluent to the drain

b) the maximum temperature of the effluent on leaving the machine
c) the maximum effective diameter of the discharge orifice from the machines chamber
d) requirement for sealed drainage system if hazardous fumes or gases are produced from chemicals used in the
process

Ventilation

a) the peak value during a cycle and the average value throughout a cycle of the heat in watts transmitted to the
environment when the decontamination equipment is operated in still air at an ambient temperature of 23C
2C
b) the heat in watts transmitted by a full load being unloaded from the machine into still air at an ambient
temperature of 23C 2C
c) the maximum flow of air extracted from the environment of the decontamination equipment as exhaust
ventilation
d) ventilation requirements for removal of fumes or gases from hazardous chemicals used in the process

Process chemicals

Details of all process chemicals required (e.g. detergents, rinse aids, sequestering agents, descalers,
microbicides, process gases) for the operation of the decontamination equipment, including any requirement for
regeneration of integral water treatment system, the quantity required per cycle, the nature and size of containers
in which they are supplied, the necessary storage conditions and instructions for safe handling.

3.71 The specification should make it clear

where services are to be connected. Care
should be taken when contracts are awarded

that precautions regarding termination and

availability of all engineering services are taken.

17

HTM 01-01: Management and decontamination of surgical instruments: Part B Common elements

Electricity

Compressed air

3.72 The electrical power requirements will

depend on a number of factors, such as the
type of machine and the method used to heat
water and hot air dryers, and generate steam.
Local or integral electrical steam generators will
result in a high electrical load. Some machines
will require a three-phase supply. The
manufacturer should provide details of the type
of supply (AC or DC), number of phases,
frequency, and voltages with tolerances and
loading.

3.77 A compressed-air supply may be required

in some types of decontamination equipment.
Where the machine does not contain an
integral air compressor, the air may be supplied
from a piped service (mains supply) or from a
local compressor.

3.73 Each machine should be connected via an

isolator. The type of isolator will depend on the
nature of the supply. Where a three-phase-andneutral supply is necessary, or where a
maximum single-phase current demand is
more than 13 A, the machine should be wired
directly to the isolator. The switch should isolate
all poles simultaneously and each pole should
be fused separately. The cable from isolator to
decontamination equipment should be fixed
and protected from the effects of heat, water
and, if applicable, steam.
3.74 Within the loading area an additional
switch should be provided so that the Operator
can electrically isolate the machine or group of
machines in the event of an emergency. The
switch should be placed between the normal
operating position and the exit door.
3.75 Sterilizers used to process heat-sensitive
loads should be connected to the essential
supplies circuit, if available, to avoid heat
damage in the event of a power failure. It is not
normally necessary for washer-disinfectors to
be connected to the essential supplies circuit.
Exceptions might include the decision to ensure
that one washerdisinfector within the SSD
remains on the essential supplies circuit.
3.76 All electrical installations should conform to
the Institution of Engineering and Technology
(IET) Regulations contained in BS 7671. Further
guidance is given in Health Technical
Memorandum 06-01 Electrical services
supply and distribution.
18

Compressed air: mains supply

3.78 If air is supplied by pipeline from a central

air-compressor system, a pressure gauge of
the Bourdon type complying with BS EN 837
should be fitted inside the plantroom and
terminated with an isolation valve.
3.79 A reducing valve or other automatic device
should be fitted to reduce the pressure of air
delivered to the machine to no more than the
maximum supply pressure specified by the
manufacturer. A pressure relief valve will
normally be required.
Compressed air: local compressors

3.80 Where it is not practicable to obtain

compressed air from a mains supply, a
dedicated compressed-air facility should be
installed to supply machines.
3.81 At least two compressors should be
provided, with auto-change between the two.
The system should be sized to meet all the
compressed air requirements of the unit.
3.82 The compressors are likely to be too noisy
to be installed with the machine, and it is better
to place them in a dedicated location away
from any noise-sensitive areas.
3.83 Components of the compressed air
system that require servicing and maintenance,
such as dryers and filters, should be located
where they are readily accessible for service or
exchange.
Air quality

3.84 The quality of air can be critical for some

applications, and some machines will

3 Design and pre-purchase considerations

incorporate appropriate filters. When the

purchaser is to be responsible for the provision
of filtered air the CP(D) should ensure that the
quality of air available meets the manufacturers
specification or the requirements given below.
a. air for controls should be free of liquid
water, filtered to 25 m (5 m for
precision controls) and lubricated with
micro-fog oil particles of 2m or less;
b. air that could come into direct contact
with the load, such as air for pressure
ballasting or drying the load, should be
filtered to remove contaminating oil-mist
and microorganisms.
It should have not more than 0.5 mg of oil
per cubic metre of free air (measured at
1013 mbar and 20C; see ISO 554), be
filtered to an efficiency of at least 95%
when tested in accordance with BS
3928, and be free of bacteria.
Drainage
3.85 Condensate from the jacket, heat
exchangers and steam traps is suitable for
recovery and should be returned to the steam
generating plant where there are means for
recovery.
3.86 All other effluent from decontamination
equipment is potentially contaminated and
should be disposed of to the main drain.
Effluent can originate from one or more of the
following sources:
a. air, condensate and steam from the
chamber drain, which might contain
chemicals and microorganisms,
especially those from a make-safe
process;
b. discharge from a water-sealed vacuum
pump, ejector or chamber vent, which
might also contain microorganisms;
c. water from a chamber cooling system;
d. water introduced to cool and dilute the
discharge from the chamber;

e. effluent discharge to sewer/foul drainage.

Ventilation
3.87 Ventilation of the area near the machines
should be ensured, to remove excessive heat
and odours, and sterilant gases or vapours
from disinfectants.
3.88 General room ventilation will be sufficient
for most machines; local exhaust ventilation will
be required for chemical disinfection systems.
3.89 Electrical systems used in ventilation
systems should take account of the high levels
of humidity that might be discharged and the
potential for this to condense within the
ventilation system, as well as the explosion risk
associated with ethylene oxide, and should
comply with the requirements of BS EN 610102-042.
3.90 Owing to the air leakage from clean to
dirty across pass-through machines (based on
the design pressure differential across these
rooms of, for example, 15 Pa), information on
the impact of these machines on ventilation
system design should be sought from
manufacturers.
3.91 All ventilation systems should meet the
ventilation requirements of the Workplace
(Health, Safety and Welfare) Regulations 1992.
3.92 Further guidance on ventilation systems
can be found in Health Technical Memorandum
03-01 Specialised ventilation in healthcare
premises.

Information to be supplied by the

manufacturer
3.93 For each purchase of decontamination
equipment, the tenderer is bound to supply
detailed information on items including
construction, delivery, service requirements,
heat emissions and contract performance (see
the Particular specifications for sterilizers and
washer-disinfectors in HTM 01-01 Parts C and
D).
19

HTM 01-01: Management and decontamination of surgical instruments: Part B Common elements

4 Validation and verification

General
4.1 This chapter of the guidance covers the
validation and periodic testing of the various
types of decontamination equipment used in
hospitals, laboratories and other healthcare
facilities.
Permit-to-work
4.2 The use of permit-to-work system should
be used for all maintenance and testing
procedures on decontamination equipment.
This should ensure the formal removal of
equipment from, and return to, service and will
provide certification of acceptance by the User.
A suggested permit-to-work form is shown on
the following pages.

Testing of decontamination
equipment
Introduction
4.3 Good decontamination practice is based
on four key aspects that ensure that the
required standards of performance and safety
are met and sustained:
a. all decontamination equipment is
subjected to a programme of validation;
b. all decontamination equipment is
subjected to a planned programme of
periodic tests performance;
c. all decontamination equipment is
operated by trained staff in its use in
accordance with a written procedure

20

including manufacturers instructions and

local procedures;
d. all decontamination equipment is
subjected to a programme of planned
preventative maintenance irrespective of
whether a preventative maintenance
scheme is operated on the premises.
4.4 Expertise on all aspects of the operation
and testing of decontamination equipment is
available from several sources including the
AE(D), AP(D), CP(D), User and manufacturer.
4.5 Schedules of tests for washer-disinfectors
and sterilizers are included in HTM 01-01 Parts
C and D. Most tests are defined in the relevant
British, European or International Standard.
These documents should be used as the prime
reference for such testing. Where there is no
current Standard, testing protocols are defined
within this guidance. Future publication of new
Standards, or revisions of existing Standards,
will render some of the content of this guidance
no longer applicable. Advice should be sought
from the AE(D) regarding the state of any
relevant Standard and the current relevance of
testing protocols defined within this HTM.
4.6 Maintenance of all decontamination
equipment is dealt with in HTM 01-01 Parts C
and D.

Responsibilities
General
4.7 Decontamination equipment should be
subjected to a planned programme of testing

4 Validation and verification

both before delivery and on-site. The on-site

testing should be carried out using the
procedures described in this guidance and
should include installation qualification,
operational qualification and process
qualification. The purchaser, manufacturer,
contractor AE(D), AP(D) and CP(D) have distinct
responsibilities.
4.8 The AE(D) should review the results of predelivery works tests carried out by the
manufacturer, and review the test instruments
provided by the contractor and/or the CP(D) to
ensure that their accuracy, calibration and
condition meet the standards for test
instruments described in Validation and
verification. The AE(D) should witness such

installation, operational and performance

qualification testing as appropriate to verify that
the requirements of the specification are met
and that the equipment is fit for purpose. New
equipment should only be brought into use
after written confirmation from the AE(D).
4.9 The CP(D) should witness the installation
checks and tests carried out by the contractor,
including ensuring that the calibration of each
test instrument provided by the contractor has
been checked on site and is satisfactory, and
should arrange for test loads to be supplied as
required. The CP(D) should carry out the
installation qualification tests, operational
qualification and performance qualification.
21

HTM 01-01: Management and decontamination of surgical instruments: Part B Common elements

Authorising Engineer (Decontamination)

(AE(D))
4.10 See paragraphs 6.306.58 on staff roles
and responsibilities in HTM 01-01 Part A.
Authorised Person (Decontamination)
(AP(D))
Role and responsibilities

4.11 The AP(D) will be an individual possessing

adequate technical knowledge and having
received appropriate training, appointed in
writing by the Designated Person (in
conjunction with the advice provided by the
22

AE(D)), who is responsible for the practical

implementation and operation of Managements
safety policy and procedures relating to the
engineering aspects of decontamination
equipment including the operation of the
permit-to-work system (see paragraph 4.2).
4.12 The AP(D) should be able to undertake the
safe and effective management aspects of the
service.
4.13 The role of AP(D) is intended to provide the
organisation with an individual who, as part of
the management infrastructure, will provide
day-to-day operational management
responsibility for the safety of the system. This

4 Validation and verification

should be an internal appointment from within

the organisation. It is, however, recognised that
in some organisations there are so few items of
decontamination equipment in use that a
service provided by a third party may be
adequate.
4.14 In most organisations the role of AP(D)
would only be one of a number of areas of
similar responsibility for the individual(s)
concerned. However, any additional
responsibilities should not reduce the
importance of the role nor impair the ability of
the AP(D) to carry out his/her duties effectively.
4.15 When the scope and range of services
dictates, healthcare organisations may wish to
consider the appointment of more than one
AP(D) to ensure that appropriate cover is
provided. In these circumstances the
organisation should appoint a senior AP(D). In
any event, organisations will need to ensure
that cover is available during the absence of the
AP(D) due to annual leave, sick leave etc.
4.16 Larger organisations may be able to
warrant the appointment of an AP(D) dedicated
full-time to the role. Even where estates roles
are contracted out, it is recommended that the
AP(D) function remains the responsibility of the
healthcare organisation. The AP(D) should
report to the Designated Person.
4.17 The AP(D) will also be responsible for:
the engineering management of
decontamination equipment;
line management and/or appointment of
the CP(D);
the safe and effective systems of work for
all installed decontamination equipment
within his/her area of responsibility;
the acceptance criteria for operational
and performance testing of all installed
decontamination equipment;
liaison with the AE(D), Decontamination
Lead and other interested professionals;

authorising the use of decontamination

equipment after major repair or
refurbishment and after quarterly or
annual tests.
Competent Person (Decontamination)
(CP(D))
4.18 The CP(D) is defined as a person
designated by Management to carry out
maintenance, validation and periodic testing of
washer-disinfectors and sterilizers. The CP(D)
should report directly to an appropriate
member of the estates department (for example
AP(D)) or should be subcontracted by them.
4.19 The principal responsibilities of a CP(D)
are:
a. to carry out maintenance tasks;
b. to carry out repair work;
c. to conduct validation tests as given in
HTM 01-01 Parts B, C and D;
d. to conduct periodic tests as given in HTM
01-01 Parts B, C and D.
Manufacturer
4.20 The manufacturer should ensure that the
decontamination equipment is designed,
manufactured and tested within a quality
system. The manufacturer should also carry out
pre-delivery works testing. The extent of testing
will depend on whether the product is in serial
production or a one-off and, for machines in
serial production, whether the manufacturer
has obtained a certificate of compliance with
the relevant British or European Standard by
means of a type test for the particular type and
size of decontamination equipment. (See BS
EN 15883 Parts 1 and 2 for type-test details for
washer-disinfectors and BS EN 285 for typetest details for sterilizers.)
Contractor
4.21 The contractor, who might also be the
manufacturer, should complete the installation
checks and tests specified in HTM 01-01 Parts
23

HTM 01-01: Management and decontamination of surgical instruments: Part B Common elements

C and D to the satisfaction of the CP(D) before

the decontamination equipment can undergo
full validation to allow acceptance. The
contractor should provide such test instruments
and equipment necessary to complete
installation checks and tests.
4.22 The CP(D) should provide the test
instruments and equipment for the remainder of
the validation tests (unless otherwise specified
in the contract). The test instruments provided
should meet the standards for test instruments
described in this chapter.
Purchaser
4.23 The Purchaser is defined as the person or
organisation that orders the washer-disinfector
or sterilizer and is responsible for paying for it.

it will meet the Users specified production

needs including installation qualification,
operational qualification and performance
qualification. Installation qualification and
operational qualification are sometimes referred
to jointly as commissioning, and should be
conducted on site. Performance qualification
may refer to testing of reference loads and
reference loading conditions performed with a
test sterilizer. A summary is shown in Table 4.
Table 4 The validation process
Validation
Purchase
specification
review

Commissioning

Performance
qualification

Installation tests

Thermometric tests

Operational tests

Microbiological
tests
Residual gas/
additive tests

Works tests
4.24 Works tests before delivery of the
decontamination equipment are intended to
verify that the equipment performs in
conformity with the results obtained from type
testing in respect of various critical attributes.
(See BS EN 15883 Parts 1 and 2 for works test
details for washer-disinfectors and BS EN 285
for works test details for sterilizers.)
4.25 For one-off designs, a more extensive
programme of works tests, similar to the
programme of type tests for machines in serial
production, is required, and the purchaser
might wish to arrange for their representative
(either the AE(D) or CP(D)) to attend the factory
to witness these tests before accepting delivery
of the decontamination equipment.

Validation
4.26 Validation is the documented procedure
required for obtaining, recording and
interpreting the results needed to show that a
process will consistently yield a product
complying with a pre-determined specification.
Validation is a total process beginning with a
review of the specification against which the
equipment is purchased. This is to ensure that
24

Cleaning efficacy
tests (to extend to
protein removal
tests)
Load dryness tests

4.27 Validation consists of tests performed by

the manufacturer/supplier/manufacturers agent
or another Competent Person
(Decontamination) defined in the following
categories:
installation qualification (IQ);
operational qualification (OQ); and
performance qualification (PQ).
Installation qualification
4.28 Installation qualification is the process of
obtaining and documenting evidence that
equipment has been provided and installed in
accordance with its specification.
4.29 The contractor or agreed alternative
should carry out the required installation checks
on delivery of the decontamination equipment,
to ensure that the machine has been supplied
and installed correctly, is safe to operate, has
been provided with satisfactory services that do
not impair the performance of the machine, and

4 Validation and verification

that in operation the machine does not interfere

with other equipment.
4.30 Ancillary equipment such as service
supplies and ventilation systems should be
checked by the contractor responsible for their
installation.
4.31 When these checks have been completed
and found satisfactory, the contractor should
carry out the installation tests necessary to
demonstrate that the decontamination
equipment is working satisfactorily. The
contractor is not required to carry out any
thermometric tests unless these were specified
in the purchase contract. Any assistance
required from the purchaser should be agreed
as part of the purchase contract.
4.32 If any modification, maintenance or repair
work is carried out on the steam, water,
compressed air ventilation, piped gas services
or drainage systems after the installation tests
have been completed, the relevant installation
tests should be repeated by the CP(D) before
the operational tests are undertaken.
4.33 The schedule for installation checks and
tests is set out in HTM 01-01 Parts C and D.
Operational qualification
4.34 Operational qualification is the process of
obtaining and documenting evidence that
installed equipment operates within
predetermined limits when used in accordance
with its operational procedures.
4.35 When the decontamination equipment has
been installed and accepted the CP(D) should
carry out a sequence of operational
performance tests to evaluate the basic
performance and safety of the decontamination
equipment. Some of these tests are identical to
those specified as installation tests, and need
not be repeated if operational testing follows
within ten working days of the completion of the
installation tests.
4.36 The schedule for operational tests is set
out in HTM 01-01 Parts C and D.

Performance qualification (PQ)

4.37 PQ is defined as the process of obtaining
and documenting evidence that the equipment,
as installed and operated in accordance with
operational procedures, consistently performs
in accordance with predetermined criteria and
thereby yields product meeting its specification.
4.38 PQ consists of tests designed to show
that:
a. for washer-disinfectors, soil removal and
cleaning have been effective throughout
the load and the washer-disinfector
chamber, and the products are of the
required standard of cleanliness, free
from process residues (when applicable).
Again, the use of a test that enables
quantitative analysis of protein removal is
to be used when appropriate
technologies become available. These
tests will be conducted on sample
instruments derived from the normal
decontamination stream. The use of test
soils for specifically for this purpose is not
envisaged;
b. decontamination conditions have been
attained throughout the load and the
machines chamber, and to the required
standard for the type of load being
processed. A thermometric test is
sufficient for most items of
decontamination equipment. Additional
microbiological tests will be required for
washer-disinfectors that use chemical
disinfectants.
4.39 In principle, it might be argued that a PQ
test is required for each loading condition that
an item of decontamination equipment is
required to process. In practice, it is possible to
identify reference loads and reference loading
conditions that present an equal or greater
challenge to the process than the loads that
might be encountered in normal use. New load
items should not be processed until one of the
following is the case:
a. PQ tests, as specified in the appropriate
validation and verification section, have
25

HTM 01-01: Management and decontamination of surgical instruments: Part B Common elements

been conducted by the CP(D) to the

satisfaction of the User and the AE(D);
b. the User is satisfied that the new load
item is represented by one of the existing
loading conditions/process cycles for
which a PQ report exists;
c. the instructions from the manufacturer of
the item are sufficiently detailed and
specific that the appropriateness of the
proposed treatment is readily apparent.
4.40 The User, in consultation with the
manufacturer(s) of the load items, the AE(D) and
the control of infection officer as necessary,
should ensure that the load is suitable for the
process to which it is to be exposed. This
should include consideration of the
compatibility of all process chemicals used.
4.41 The process selected will depend on the
nature of the load and its ability to withstand the
environmental conditions present during the
operating cycle. The rates of change of cycle
variables, such as temperature and pressure,
might also need to be considered.
4.42 Before selecting a process it might be
necessary to carry out preliminary tests on the
product, or on a surrogate product, to
determine both the levels and rates of change
of the cycle variables necessary to achieve the
required result, and to determine which can be
tolerated by the product without causing
unacceptable changes in its performance.
Otherwise, manufacturers instructions may be
used.

Loading
4.43 The User should ensure that each load is
presented to the process in accordance with
documented procedures established and
tested during PQ.
4.44 Baskets or load carriers should not be
overloaded, as this will result in inefficient
cleaning and disinfection.

26

4.45 Cannulated load items, which are intended

to be connected to spigots on the load carrier
to ensure flushing of the lumen, should be
properly connected, as otherwise they will not
be adequately cleaned and disinfected.
4.46 Small and light items should be secured
with a hold-down screen or by other means; if
they are free to move around there is a serious
risk of damage to the instruments. Small, sharp
instruments that have moved within the load
could also represent a hazard to staff who have
to subsequently handle the load.
4.47 Load carriers should only be used with the
items for which they were intended.

Documentation
4.48 Accurate and efficient record-keeping is
an essential part of the management of
decontamination equipment. The extent and
nature of the records that are necessary varies
with the type of machine and the use to which
it is put. Guidance is given in HTM 01-01 Parts
C and D.
Summary sheets
4.49 On completion of the validation process,
and before leaving the premises, the CP(D)
should prepare a summary report containing
the results of the commissioning and PQ tests
and essential working data.
4.50 At the request of the User the CP(D)
should also supply graphical representations of
cycle variables obtained from the thermometric
tests.
4.51 The summary report should be signed by
the CP(D) and countersigned by the AP(D) to
certify that the machine is fit for use.
4.52 Summary reports should be securely
retained by the User and be available for ready
reference.
4.53 At the same time the CP(D) should provide
the User with copies of any master process
records required for routine production.

4 Validation and verification

Validation report
4.54 Within one month of the completion of the
validation process the CP(D) should prepare a
full validation report which should include:
a. all the data supplied by the contractor,
collected during the installation checks
and tests with written confirmation that
they meet the manufacturers
specification;
b. written confirmation that the calibration of
all measuring instruments fitted to the
machine have been verified;
c. all the data collected during the
commissioning tests, with written
confirmation from the CP(D) that they
meet the specified requirements;
d. data showing the correlation between the
performance of the measuring
instruments fitted to the machine and the
test instruments used during
commissioning and PQ;
e. reports containing all the data collected
during the PQ tests, with written
confirmation from the CP(D) and the User
of the loading conditions and types of
load (including, when necessary,
reference to specific individual items) that
may be satisfactorily processed in the
machine;
f. data from the instruments fitted to the
machine, independent monitoring system
data and validation instrument data,
along with comments on any changes or
adjustments made.
4.55 When data is in the form of electronic data
files, the report should include copies of disks/
DVD or CD or tapes containing the data in a
format compatible with local systems and
policies and a printout of the directory of each,
annotated to show where the data for each test
is to be found.
4.56 The CP(D) should certify that all necessary
tests have been carried out and that the results
were satisfactory.

4.57 The records of any microbiological tests

should be signed by the Microbiologist.
4.58 The AP(D) should forward the completed
validation report to the AE(D) for audit. The
AE(D) should issue a report of findings to the
User, with a copy to the AP(D) and
Decontamination Lead. The validation report
should be returned to the User via the AP(D).
4.59 The validation report should be retained by
the User. Copies may be retained as necessary
by the CP(D), the AE(D), the Microbiologist and,
where applicable, the Quality Controller.

Periodic tests
4.60 After validation and when the machine is
passed into service, it should be subject to a
schedule of periodic tests at daily, weekly,
quarterly and yearly intervals, to provide
evidence that the machine continues to operate
within the limits established during
commissioning.
4.61 The User and the CP(D) (under the
management of the AP(D)) are responsible for
the periodic tests.
4.62 The yearly test schedule is a revalidation
procedure and provides a more comprehensive
test programme than the other periodic tests; it
serves to demonstrate that data collected
during commissioning and the PQ remain valid.

Revalidation
4.63 In addition to annual revalidation,
revalidation is required under the following
circumstances:
a. when the machine is to be returned to
service after repair or component
replacement of part of the systems that
affect satisfactory attainment of the preset variables of the operating cycle;
b. when the pre-set values of the cycle
variables have been modified;

27

HTM 01-01: Management and decontamination of surgical instruments: Part B Common elements

c. when the software in a programmable

electronic system (PES), used for control
of the process, has been modified;
d. whenever the User or AE(D) advises that
revalidation is necessary:
(i) when the pattern of a batch process
record is outside the limits specified
on the master process record;
(ii) when the equipment fails a periodic
test;
e. whenever it is required by an authorised
inspectorate or licensing authority.
4.64 The full revalidation procedure is identical
to that specified for the yearly test.
4.65 It will not always be necessary to carry out
a full revalidation, and the advice of the AE(D)
should be sought on which tests are required
following any particular event.

Repeat validation
4.66 Revalidation and periodic tests are
designed to establish the continued
conformance of the equipment and its
performance with data established during the
original validation study.
4.67 There are occasions when it might be
necessary to repeat the full set of tests carried
out during the initial validation in order to obtain
a new set of data.
4.68 Repeat validation should be carried out if:
a. the machine is modified to such an extent
that it must be presumed that the original
data is no longer valid;
b. a machine has been moved and installed
at a new site;
c. the machine has been dismantled or
extensively overhauled;
d. a new operating cycle has been
introduced;

28

e. the User or AE(D) advises that repeat

validation is necessary;
f. it is required by an authorised
inspectorate or licensing authority;
g. revalidation fails to confirm compliance
with the original data and no cause for
the discrepancy can be found;
h. there have been time and temperature
adjustments or parameter changes.
4.69 It will not always be necessary to carry out
a full repeat validation, and the advice of the
AE(D) should be sought as to which tests are
required following any particular event.

Types of test
4.70 The tests listed in the schedules fall into
the following categories:
a. Automatic control tests, which are
designed to verify the correct functioning
of the operating cycle from the readings
obtained from the instruments fitted to
the machine;
b. Thermometric tests, which are designed
to provide assurance that the
temperature requirements for the process
are met by using accurate measuring
equipment, independent of the
instruments fitted to the machine to
monitor the temperatures attained within
the chamber and reference loads;
c. Thermometric tests for a small load,
which are designed for two purposes. In
sterilizers with an active air removal
system they demonstrate that the
sterilizer is capable of removing air from a
small load in which air from a near-empty
chamber has been retained.
Thermometric tests for a full load are
designed to show that services provided
to the machine are adequate for purpose.
In certain circumstances they may also
serve as PQ tests for loading conditions
that present a lesser challenge to the

4 Validation and verification

operating cycle than the specified full

loads;
d. Microbiological tests, which are
designed to show that disinfection
(sterilization) conditions are attained when
thermometric methods alone are
inadequate for this purpose;
e. Cleaning efficacy tests, which are
designed to show, by monitoring the
removal of a test soil, that the process will
effectively clean products of the type to
be processed.
4.71 Other tests, specific to certain types of
sterilizer, are designed to show that the steam
supply is suitable, the sterilizer does not
produce too much noise, the chamber is
airtight, gaseous sterilants are not released into
the environment, and safety devices are
functioning correctly.
4.72 Other performance tests specific to certain
types of machine are designed to provide
assurance that the machine will perform
correctly under the anticipated conditions of
use.

4.76 The AE(D) and the User should agree the

course of action to be taken.
4.77 The User has the ultimate responsibility for
certifying that decontamination equipment is fit
for use.

Principles of installation and

operational tests
4.78 On delivery of decontamination
equipment, the contractor should carry out the
installation checks included in the contract and
as set out in this chapter to establish that:
a. the equipment has been provided and
installed correctly;
b. the equipment is safe to operate;
c. the equipment does not interfere with
other equipment;
d. all connected services are satisfactory
and do not prevent attainment of the
designed cleaning and disinfection/
sterilization performance of the
equipment.

4.73 There should be no difficulty in ensuring

that a correctly installed and maintained piece
of decontamination equipment will comply with
both the validation tests and periodic tests
described.

4.79 The contractor responsible for installing

the equipment should carry out installation
checks on services and other ancillary
equipment. These checks should be completed
and all services and ancillary equipment found
to be satisfactory before carrying out installation
checks on the equipment itself.

4.74 Failure of a test generally indicates that a

machine is not working to specification; it
should be withdrawn from service and the
failure investigated.

4.80 The contractor responsible for installing

the decontamination equipment should carry
out any additional checks specified by the
manufacturer.

4.75 In practice the action to be taken is a

matter of judgement and will depend on the
nature of the failure and the use to which the
machine is being put. It might be acceptable for
the equipment to continue operating under
carefully defined restrictions until the cause of
the failure can be established and rectified.

4.81 The CP(D) should carry out any checks

specified in this chapter that were not included
in the purchase contract for the
decontamination equipment.

Procedure on failure of a test

4.82 Installation tests are defined in HTM 01-01

Parts C and D.
4.83 Operational tests are performed in
standard specified manner using defined

29

29

HTM 01-01: Management and decontamination of surgical instruments: Part B Common elements

reference loads. Details of operational tests are

defined in HTM 01-01 Parts C and D.

Principles of performance
qualification tests
Introduction
4.84 Performance qualification (PQ) is defined
as the process of obtaining and documenting
evidence that the equipment, as installed and
operated in accordance with operational
procedures, consistently performs in
accordance with predetermined criteria and
thereby yields product meeting its specification.
4.85 PQ tests should be performed as part of
the initial validation procedure, as part of any
repeat validation procedure and whenever the
User, acting on the advice of the AE(D), judges
that new loading or operating conditions require
a new PQ test.
4.86 Circumstances that might lead to new PQ
tests would include changes to the quality of
the water supply, changes to the chemical
additives used in the cleaning and disinfection
process, changes to the loading system or the
requirement to process a new type of product
or packing arrangements for decontamination
equipment.
4.87 PQ should not be undertaken on any piece
of equipment until the requirements of the
installation and operational tests specified in
HTM 01-01 Parts C and D have been met.
4.88 Soil removal efficacy tests should be
carried out on all washer-disinfectors as part of
the PQ (see HTM 01-01 Part D).
4.89 Thermometric PQ may not be required for
all loads. Consideration should be given to tests
for effective sterilization and drying of metal
loads, and of any particular loads agreed
between the User and the AE(D).
4.90 PQ tests should be carried out by the
CP(D).

30

4.91 Each test should be cross-referenced to a

detailed description of the test procedure.
Unless otherwise specified, the tests should be
carried out with the decontamination equipment
at normal working temperature, which might
require a warm-up run to be carried out
before commencement of the tests.
4.92 Test data obtained from the PQ tests
should be recorded in a written PQ report that
clearly identifies the loading conditions, the
operating cycles, any chemical additives, and
the water and steam quality used at each stage
of the cycle.
4.93 The User should employ the PQ report to
confirm the suitability of the process for loads
that are to be processed. It should be used by
the CP(D) and AE(D) as the basis for
comparison with subsequent performance
requalification tests.
4.94 Performance requalification (PRQ) is the
process of confirming that the equipment
continues to meet the performance standards
established during PQ and that the working
data established during PQ tests remain valid.
4.95 PRQ is carried out annually as part of the
yearly test schedule, as part of any revalidation
or repeat validation study, or whenever the User
requests such confirmation.
4.96 Before undertaking PRQ tests the CP(D)
should confirm, either by testing or by reference
to current test records, that the machine meets
the requirements of the installation and
operational tests.
Loading conditions
4.97 A loading condition is a specified
combination of the nature and number of load
items, the items of chamber furniture, and their
distribution within the chamber. For example, a
load placed on the top-most level of a four-level
load carrier constitutes a different loading
condition from the same load placed on the
lowest level.

4 Validation and verification

4.98 In principle, validation is not complete until

a PQ test has been performed for each loading
condition that the equipment is expected to
process.
4.99 In practice, the loading conditions
specified in the tests to be carried out during
commissioning are designed to represent the
majority of production loads and to present a
greater challenge to the process than
production loads. In these cases further PQ
tests will not be required; the data obtained
from the commissioning tests will be sufficient.
4.100 PQ tests are required under the following
conditions:
a. when the proposed production loading
condition presents a greater challenge
to the process than that presented by
the commissioning tests; for example,
washer-disinfectors for surgical
instruments will require PQ tests if the
mass of metal instruments to be
processed exceeds that of the
standard test load or if it is intended to
process instruments with narrow
lumens. Also, while porous load
sterilizers rarely need PQ tests, such
tests will be required if the density of
the porous material exceeds that of the
standard test pack (see Testing:
additional information in HTM 01-01
Part C) or if narrow lumens restrict air
removal and steam penetration;
b. when the nature of the load is not
represented by the commissioning
tests; for example, certain loads might
be damaged by exposure to the normal
cycle temperature. In these cases, the
settings of cycle variables and their
permitted tolerances should ensure not
only that the load is correctly
processed, but also that it is not
unacceptably degraded by long
exposure to high temperatures.
4.101 When PQ tests are required, it is often
possible to select a production load that is
known to be a greater challenge to the process

than any of the others. This reference load

can then serve as a worst case and allow one
PQ test to be valid for a range of less
demanding conditions. For sterilizers, reference
should be made to BS EN 17665 prior to
commencing this process.
4.102 A microbiological PQ test may be
required for determining air removal and steam
penetration into complex devices where
thermometric methods may prove inadequate.
The advice of the AE(D) should be sought in
such cases.
4.103 The responsibility for deciding which
loading conditions require PQ tests should be
considered by the User, CP(D) and AE(D). The
AP(D) should be made aware of the decisions
made.
PQ report
4.104 All the data collected during PQ tests
should be filed in a PQ report, a copy of which
should be kept with the plant history file.
4.105 The PQ report should contain or refer to
the complete specification for the
decontamination process. The specification
should be sufficiently detailed to allow the
loading condition and the operating cycle
(including the type and volume of all chemical
additives and the water quality) to be replicated
on any future occasion.
4.106 The report should include the following:
a. a specification of the loading condition
defined by the nature and number of
the load items, items of chamber
furniture and their distribution within the
chamber. Photographs taken of the
load are valuable for future reference
and can minimise the need for
extensive descriptive text;
b a specification of the operating cycle,
defined the settings for the cycle
variables. For microprocessor-based
control systems a copy of the program

31

HTM 01-01: Management and decontamination of surgical instruments: Part B Common elements

held independently on electro-magnetic

storage media is suitable also;
c. a specification of the service supply,
defined by reference to the nature and
volume of all chemical additives and the
quality of the water service(s);
d. a specification of any preconditioning,
conditioning and degassing process;
e. a specification of any pre-test operation
of the decontamination equipment, for
example a warm-up cycle;

4.109 The User, in consultation with the AE(D),

should establish and document procedures to
ensure that loads are not released for use until
the User is satisfied that the product has been
processed within permitted equipment cycle
parameters established during validation/
performance qualification, for each stage of the
decontamination process.
4.110 Product release procedures should
confirm, for example:

f. a specification of any pre-treatment of

the test load, for example manual
cleaning, ultrasonic cleaning etc;

that the process equipment loading

arrangement is consistent with that
used during validation/PQ testing;

g. all the indicated, recorded and

measured data from the test. These
should be annotated with the target
values and permitted tolerances of
elapsed time and other cycle variables
at all significant points of the operating
cycle, for example at the beginning and
end of each stage or sub-stage;

that the products have been packaged

and assembled in accordance with the
PQ specification, and that the process
has not resulted in any damage or
deterioration of packaging;

h. for loads which require the removal of

air before sterilization, the method used
to verify whether the minimum
conditions of steam penetration into the
load are attained (for porous load
sterilizers, this is by use of the air
detector);

that the process equipment batch

process record meets PQ specification
for all cycle variables.

j. for machines equipped with process

recording, the original of the process
record derived from the test should
also form part of the record.
4.107 Immediately following the PQ tests, the
CP(D) should prepare PQ summary sheets and
working copies of any necessary master
process records. These should be given to the
User and kept with the sterilizer process log.
4.108 If PQ tests are not required, the PQ
summary sheet should contain data from the
thermometric test for a full load and be marked
accordingly.

32

Product release

that the operating cycle for process

equipment is in accordance with the
PQ specification;

4.111 Confirmation that the process equipment

batch process record meets PQ specification
for all cycle variables may be achieved
automatically via an independent process
variable monitoring system (IMS) which
compares cycle process control data and
independent process variable monitoring data
and confirms cycle performance within
validated cycle parameters; or by manually
comparing the batch process record (BPR) with
a master process record (MPR) of the validated
PQ test, and noting the outcome on the BPR
together with the operators signature and
reference number of the MPR used.
4.112 The performance and requirements of
independent process variable monitoring
systems are detailed in the Particular
specifications for sterilizers and washer-

4 Validation and verification

disinfectors given in the appendices of Parts C

and D respectively.
4.113 A master process record may take the
form of a transparent copy of the batch process
record for the equipment validated PQ test, with
variable limits specified and the MPR suitably
referenced; or other convenient system which
allows the operator to confirm that the
production cycle parameters are within those
established during the validated PQ test.
Differing process cycles will require different
MPRs.

Tests for performance

requalification (PRQ)
4.114 PRQ tests should be performed once a
year to ensure that the established criteria for
decontamination are still being met. The PRQ
tests should follow the yearly schedule of tests
and checks listed in the specific sections for
sterilizers and washer-disinfectors.
4.115 For a given operating cycle the PRQ
tests should only be carried out for those
reference loads for which a PQ test was
performed and reported.

4.116 The need for additional PQ tests in the

light of changes in the nature of loads being
processed should be agreed between the User
and the CP(D).
4.117 The procedure for the PRQ test is
essentially the same as that used for the
corresponding PQ test. The operating cycle and
the loading conditions used should be identical
with those used previously for the PQ test.
4.118 The PRQ test should be considered
satisfactory if the values of the measured
variables are within the tolerances stated in the
PQ report.
4.119 The results of the PRQ tests should be
linked with the relevant PQ report and retained
securely.
4.120 The PRQ test should meet the specified
requirements without difficulty for
decontamination equipment that has passed
the yearly test programme. If the PRQ test is
not satisfactory the advice of the AE(D) and/or
the manufacturer should be sought.
4.121 Full details of PRQ tests can be found in
HTM 01-01 Parts C and D.

33

HTM 01-01: Management and decontamination of surgical instruments: Part B Common elements

References

Choice Framework for local Policy and

Procedures 01-01 Management and
decontamination of surgical instruments
(medical devices) used in acute care. Part A
The formulation of local policy and choices.

BS EN ISO 13485.

Choice Framework for local Policy and

Procedures 01-01 Management and
decontamination of surgical instruments
(medical devices) used in acute care. Part C
Steam sterilization.

BS 6447.

Choice Framework for local Policy and

Procedures 01-01 Management and
decontamination of surgical instruments
(medical devices) used in acute care. Part D
Washer-disinfectors.
Choice Framework for local Policy and
Procedures 01-01 Management and
decontamination of surgical instruments
(medical devices) used in acute care. Part E
Alternatives to steam for the sterilization of
reusable medical devices.

BS EN 60751.
BS EN 60584-2.

BS EN 837-1.
ISO 4064-1.
BS 5898, ISO 384.
BS EN 61672-1.
BS EN 61672-2.
BS EN ISO 14644-1.
Health Building Note 13 Sterile services
department.
Provision and Use of Work Equipment
Regulations 1998.

Medicines and Healthcare products Regulatory

Agency (MHRA).

Health and Safety (Miscellaneous Amendments)

Regulations 2002.

ISO 11139:2006 Sterilization of health care

products vocabulary.

Electromagnetic Compatibility Regulations

2005.

ISO/IEC 17025.

BS EN 61000-6-3.

BS EN 285.

BS EN 61000-6-1.

BS EN ISO 15883.

PD 5304.

BS EN 15883-1.

BS EN 61010-1.

BS EN 15883-2.

BS EN 61010-2-040.

34

References

HSE Guidance Note PM73.

NHS Supply Chain.
Firecode (Health Technical Memorandum 05series).
Health Building Note 26 Facilities for surgical
procedures.
Workplace (Health, Safety and Welfare)
Regulations 1992.
Approved Document B.

HTM 06-01 Electrical services supply and

distribution.
ISO 554.
BS 3928.
BS EN 61010-2-042.
HTM 03-01 Specialised ventilation in
healthcare premises.
BS EN 17665.

IET Wiring Regulations (BS 7671).

35