Sterilizers Autoclave

Aleppo University
Faculty of electrical & electronic Eng.
Medical Instrument Dep.
March 2009
In today' s world, the need for

infection control has never
been greater .
Supervision Dr. Hassan Sharabaty
By Hani al Meer
Introduction
n today's world, the need for infection control has never been greater .The patients and the
health care professionals have become more concerned about the transmission of pathogenic
organism then ever before.
Controlling microbial contamination through sterilization has long been considered the most
essential component of an infection control program. The result of proper instrument sterilization
is the protection of the patient, and the health care professional from various infection diseases.
The focus on infection control has sharpened.
Since infections increase the severity of illness, complicate recovery, and prolong inpatient stays
they raise the cost of care.
The ever growing expense of health care has focused providers' attention on reducing costs. Often
this means re-sterilizing and re-using expensive plastic items that might otherwise be discarded.
Instruments must be sterilized between usage.[1]
Until recently, the most advanced sterilization technology was found only in large hospital
sterilizers. Today there is a growing demand for more sophisticated sterilization technologies in
veterinary, dental and private clinics as well as tattoo parlors and beauty salons. [3]
There are several types of sterilization equipment. Dry heat sterilizers, heated chemical vapor
sterilizers, Steam sterilizers (autoclaves), and gas sterilizers.[1]
Dry Heat
The dry heat sterilizers employ higher temperatures to destroy microorganisms. They are
considered effective and safe for metal instruments because the process does not dull instrument
edges or rust/corrode the instruments. There are two kinds of 'Dry heat sterilizers'. The traditional
'toaster oven' style that is slow and take an hour to sterilize at 320f (160c), or the COX Rapid Heat
sterilizer which is using a patented forced air and baffle system technology to sterilize in 6
minutes at 375f (190c). CDC guidelines calls for weekly monitoring the working of the dry heat
sterilizer by doing a weekly spore test.
Heated Chemical Vapor Sterilizers

These type of sterilizers also offer relatively short cycle times. Metal instruments can be
processed with minimal rust or corrosion, and cutting edges remain sharp; however, instruments
must be dried completely before processing. The sterilizer requires a special solution; and heat
sensitive plastics may be destroyed. In addition, the unit must be placed in a well ventilated area
to diffuse the chemical odor. CDC guidelines calls for weekly monitoring the working of the
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Chemical Solution
Liquid disinfectants, such as glutaraldehyde, are widely used in health care facilities. They have
short, inexpensive disinfection cycles. However, glutaraldehyde can not be used for all medical
materials. Typical cycle times and concentrations only provide disinfecting, which can fail to kill
resistant microorganisms. The solutions are highly corrosive and toxic; since they come in liquid
form, they can not be used with barrier packaging. The moment an instrument is removed from
the liquid, its sterility is compromised. Immersion in a liquid sterilant is not recommended
because sterilization by liquid chemicals can not be monitored biologically. In addition,
instruments disinfected by liquids must be handled aseptically, rinsed in sterile water, and dried
with a sterile towel. Furthermore, instruments immersed in liquid sterilants are not wrapped and,
therefore, must be used immediately or stored in a sterile container, according to the American
Dental Association Councils on Scientific Affairs and on Dental Practice's "Infection Control
Recommendations for the Dental Office and the Dental Laboratory," presented at the 1996 OSAP
Scientific Forum.
Glass Bead Sterilizers
Glass bead sterilizer have long been employed for instruments re-used on the same patient at a
single appointment; however, they are not suitable for terminal sterilization of instruments prior
to re-use on other patients. The reason they are not effective is that there isn't a way to test the
temperature throughout the cycle. In fact, glass bead sterilizers are not FDA approved, and any
new machines must receive pre market approval, according to Dr. Janie Fuller with the infection
control devices branch of the U.S. Food & drug Administration.[1]
Steam Sterilizer ( autoclave )
An autoclave is a pressurized device designed to heat aqueous solutions above their boiling point
at normal atmospheric pressure to achieve sterilization . It was invented by Charles Chamberland
in 1879.[2]
The benefits of sterile surgery were starting to catch on

and doctors needed a more reliable way to sterilize their
instruments besides heating them in the fire. The
benefits of the autoclave were quickly evident, and it
became an indispensable part of every doctor’s office
and hospital.
The autoclave is not quite as common, with the

introduction of single-use needles and other instruments,
but it is still a necessary part of any medical or lab
setting [4].
And it is also used to describe an industrial machine in which elevated temperature and pressure
are used in processing materials.[2]
Under ordinary circumstances (at standard pressure), liquid water cannot be heated above
approximately 100 °C/212 °F (99.99 °C at 101.325 kPa, 99.62 °C at 100 kPa) in an open vessel
(see here for special situations ). Further heating results in boiling , which is the transition from
liquid to gas, but does not raise the temperature of the liquid water. However, when water is
heated in a pressurized vessel such as an autoclave, it is possible to heat liquid water to a much
higher temperature. As the container is heated the pressure rises due to the constant volume of the
container (see the ideal gas law ). The boiling point of the water is raised because the amount of
energy needed to form steam against the higher pressure is increased. [2]
Steam sterilizers will allow you to sterilize a wide range of materials. Temperature, pressure, and
time are the main factors of this process. The higher the temperature, the greater the pressure and
the shorter the sterilization cycle. Maximum temperature will rise to 273f (133c). Steam
sterilization , however, may cause unprotected instruments to corrode and unprotected cutting
edges to dull. Furthermore, excess water in the steam can provide a portal for microorganism to
penetrate wet instrument packages. Steam sterilizers (autoclaves) are the most popular method of
sterilization and are made and sold throughout the world. CDC guidelines calls for weekly
monitoring the working of the steam sterilizer by doing a weekly spore test.[1]
Uses
Autoclaves are widely used in microbiology, medicine, sterilizing instruments for body piercing ,
veterinary science, dentistry, podiatry and metallurgy. The large carbon-fiber composite parts for
the Boeing 787, such as wing and fuselage parts, are cured in large autoclaves.[2]
Autoclave is also used - as well as - in tattoo parlors and beauty salons .[3]
Non-sterilization applications
Many other systems use hot water or steam and Priorclave autoclaves have been adapted for the
following applications: food processing (simultaneously cooking and shrink wrapping
vegetables); plastics (re-hydration of molded nylon components); accelerated curing; construction
(testing conditions for curing roof tiles) .[7]
Types of autoclave
 Front loading (cylindrical chamber or rectangular chamber from 40 liter to 700 liter)
 Top loading (cylindrical chamber from 60 liter to 200 liter)
 Pass through or double-ended (so that load enters in one room and is taken out when
autoclaved via other door in an adjoining
room). Cylindrical chambers of 150 or 200
liter and rectangular chambers of 350, 450
or 700 liter).[6]
 Large Hospital Sterilizers which is similar

to a dishwasher. A hospital autoclave can
process large numbers of surgical instruments in one cycle , keeping up with the constant
demand from the operating rooms and
emergency department.
An autoclave should ideally be a one-touch

instrument. That is, the technician should be
able to load the machine, press a button to begin
the cycle, and the machine does the rest. The
technician should not have to monitor the unit
constantly for temperature or to begin or end a
cycle.[4]
Technical requirements:
Sterilizer chamber
Sterilizer chamber is made of materials which shall not release any

substances known to be toxic in such quantities that can create a health or
environmental hazard. These materials should have a high humidity
resistance
The chamber size differs from one to other by type , uses , needs , and
stainless steel chamber
the location of the sterilizer .
The chamber should also be provided with one or tow doors and
interlocks that make opening the sterilizer door(s) during the
cycle is not possible .
Also the inner sterilizer chamber surface have to be heated to
achieve preset temperature .(see Annex A) Double locking safety device
Evacuation system
When the goal of autoclaving is to achieve sterility, it is very important to ensure that all of the
trapped air is removed. The reason for this is that hot air is very poor at achieving sterility. Steam
at 134 °C can achieve in 3 minutes the same sterility that hot air at 160 °C takes two hours to
achieve. Autoclaves may achieve air removal by various means including:
 Downward displacement (or gravity type) - As steam enters the chamber, it fills the
upper areas as it is less dense than air. This compresses the air to the bottom, forcing it
out through a drain. Often a temperature sensing device is placed in the drain. Only when
air evacuation is complete should the discharge stop. Flow is usually controlled through
the use of a steam trap or a solenoid valve, but bleed holes are sometimes used, often in
conjunction with a solenoid valve. As the steam and air mix it is also possible to force out
the mixture from locations in the chamber other than the bottom.
 Steam pulsing - Some autoclaves remove air by using a series of steam pulses, in which
the chamber is alternately pressurized and then depressurized to near atmospheric
pressure.
 Vacuum pumps - Some autoclaves use vacuum pumps to suck air or air/steam mixtures
from the chamber.
 Superatmospheric - This type of cycle uses a vacuum pump. It starts with a vacuum
followed by a steam pulse and then a vacuum followed by a steam pulse. The number of
pulses depends on the particular autoclave and cycle chosen.
 Subatmospheric - Similar to superatmospheric cycles, but chamber pressure never
exceeds atmospheric until they pressurize up to the sterilizing temperature.[2]
Aeration system
When the sterilizer chamber is ventilated during the aeration for the purpose of desorption and to
release the vacuum at the end of the process, microbial recontamination of the sterilization load shall be
prevented by a filter (see Annex A).
Temperature
 Measuring devices
o When used for process control, monitoring or registration purposes, temperature
measuring devices
o shall have maximum permissible errors of 1 K or less over the scale range 20 °C to 100
°C and be adjusted to± 0,5 K or less at the sterilization temperature.
o Temperature control systems shall be protected against unauthorized operation by the use
of an access device.
o At least two independent sensors shall be used for the measurement of the chamber
temperature,
being dedicated to indication, control and registration. The sensors shall be located in
the most representative position in the chamber specified as being the reference
measuring point.
o The registration and monitoring/controlling devices shall be mutually independent as
given by any of
the arrangements shown in Figure 3.
o The temperature sensor including the measuring system it is connected to shall have a
response time
τ0,9 < 5 s when tested in flowing water according to EN 60751.
o Temperature control systems shall have a function which causes a fault to be indicated if
a sensor fails.
 Indicating devices
There are physical, chemical, and biological indicators that

can be used to ensure an autoclave reaches the correct
temperature for the correct amount of time.
Chemical indicators can be found on medical packaging

and autoclave tape, and these change color once the correct
conditions have been met. This color change indicates that Sterilization bags often have a
the object inside the package, or under the tape, has been "sterilization indicator mark" that
autoclaved sufficiently. Biological indicators include attest typically darkens when sterilization
temperatures have been reached.
devices. These contain spores of a heat-resistant Comparing the mark on an unprocessed
bacterium, Geobacillus stearothermophilus. bag (L) to a bag that has been properly
cycled (R) will show an obvious visual
If the autoclave does not reach the right temperature, the difference.
spores will germinate, and their metabolism will change the color of a pH-sensitive chemical.
Physical indicators often consist of an alloy designed to melt only after being subjected to 121 °C
or 249 °F for 15 minutes. If the alloy melts, the change will be visible.
In addition to these indicators, autoclaves have timers, temperature and pressure gauges that can
be viewed from the outside.
There are certain plastics that can withstand repeated temperature cycling greater than the 121 °C
or 249 °F required for the autoclaving process. PFA, polypropylene, polysulfone and Noryl are
examples.
Some computer-controlled autoclaves use an F0 (F-naught) value to control the sterilization cycle.
F0 values are set as the number of minutes of equivalent sterilization at 121 °C or 249 °F (e.g.: F0
= 15 min.). Since exact temperature control is difficult, the temperature is monitored, and the
sterilization time adjusted accordingly.[2]
 Measurement probe considerations
The rigorous environment of autoclave sterilizer chambers means that temperature

measurement probes must be designed to cope with high levels of pressure and moisture
Autoclave load thermocouple assemblies are specially designed to provide the best possible
accuracy and stability in the rigorous environment of sterilizer chambers.
The proven, Labfacility design has been subjected to successful, thorough evaluation by CMI
Healthcare including leak testing in a vacuum chamber and processing through normal, porous
load sterilization cycles.
The sensor complies with test standard HTM 2010, clause 6, 19/6.21.
Harsh conditions in the autoclave subject the thermocouple to high levels of pressure and
moisture.
A special multiple seal construction in this design of autoclave thermocouple ensures that
moisture ingress is prevented, even at elevated pressure.
The combination of a type T thermoelement and exceptionally rugged construction ensure high
accuracy, high stability and long term reliability.
Ordinarily, in order to achieve the sort of accuracy demanded for such an application, typically +/-
1C or better, the sensor would utilize a platinum resistance thermometer.
However, such a sensor would be prone to damage in harsh physical conditions and also be
particularly vulnerable to deterioration due to the ingress of moisture if any seals were damaged.
This design of type T thermocouple assembly uses close tolerance, selected thermocouple wire to
achieve the high accuracy and stability needed for sterilizer applications but combined with the
ability to withstand arduous conditions and handling.
The sensor is protected by a 316 grade stainless steel sheath and bulkhead tube: strong, flexible
stainless steel armour conduit protects the extension lead with an additional length of silicone
rubber exiting the bulkhead tube.
The cable is colour coded to BS EN IEC 584-3.

Single and duplex versions can be constructed.
By locating the sensor in close proximity to the 'load' inside the autoclave, an accurate measure of
the temperature applied to the actual product is obtained as opposed to simply monitoring the
internal temperature of the autoclave in the chamber wall; control of the autoclave temperature is
typically based on such a location.[5]
Pressure
 Measurement devices
o When used for control, monitoring or registration purposes, pressure measuring

and indicating systems shall be protected against unauthorized operation by the
use of an access device.
o When used for process control, monitoring or registration purposes, absolute
pressure measuring systems shall be used.
o At least two independent sensors shall be used for the measurement of the
chamber pressure, being dedicated to indication, control and registration.
o The registration and monitoring/controlling devices shall be mutually
independent as given by any of the arrangements shown in Figure 3.
o When used for process control, monitoring or registration purposes, pressure
measuring and indicating chain shall have maximum permissible errors of 1 % or
less over the scale range, and be adjusted to ± 0,8 kPa (± 0,008 bar) or less over
the range from 0 kPa (0 bar) up to the sterilization pressure.
o When used for process control, monitoring or registration purposes, pressure
measuring systems shall have a function which causes a fault to be indicated if a
sensor fails.
 Indicating devices shall:
o be graduated in kilopascals or bars.
o have a scale which includes the range 0 kPa (0 bar) to at least 10 % above the
maximum process operating pressure when used for process control or monitoring
purposes.
o have maximum permissible errors as specified in 4.3.4.5 when used for process
control or monitoring purposes or have maximum permissible errors of 1,6 % or less
over the scale range at others.
o for analogue instruments, be graduated in divisions not greater than 5 kPa (0,05 bar)
when used for process control or monitoring purposes and in divisions not greater
than 20 kPa (0,2 bar) at others.
o for analogue instruments indicating overpressure, have the maximum allowable
operating pressure legibly identified.
o for digital instruments, have a resolution of not greater than 0,5 kPa (0,005 bar) and
be adjusted to better than 0,8 kPa (0,008 bar) from 0 kPa (0 bar) to the sterilization
pressure.
Figure — Arrangements for temperature and pressure sensors
Timers and time indicating devices

o A timer shall control the holding time.
o Time periods within the process shall have an uncertainty of measurement of ±1,0 s or
less.
o If dates and times are indicated, the formats yy:mm:dd and hh:mm:ss shall be used as
applicable.
o The time period of each time controlled part of the sterilization cycle shall be adjustable
by the means of an access device.
o Means shall be provided, independent of the process control, to verify the time period of
each stage of the sterilization cycle
Recording instruments
o The recorder shall be independent such
that the measuring chain as well as value
data processing and printed values are
separate from the automatic controller.
NOTE 1 This does not exclude the transfer of
informative data from the automatic controller to
the recorder and vice versa , via a combined
system for data transfer.
NOTE 2 Sterilizer identification, cycle number and
load identification may be recorded automatically.
o For operational inspection as well as for batch documentation, analogue or digital
recorders shall record pressure and temperature data versus time. The records shall allow
evaluation of the data for compliance with specified temperature and pressure profiles
throughout the operating cycle .
Services Required
(general, may vary with autoclave and application)
 Electrical Supply
380/415 volts, 50 Hz, three phase rated at 15 amps per phase with earth and neutral or
240 volts, 50Hz, single phase rated at 30 amps with earth and neutral terminated at a
suitably fused switched socket RS Components Stock Number 367 4086 within 2 meters
run of the rear of the Priorclave.
 Steam supply (if required)
Not required, but you can ask for one if you want more service.
 Water Supply
Not required, manual fill. If the Auto Water Filling option is supplied then a 15mm cold
water supply terminated at a stopcock within 2 meters run of the rear of the Priorclave
should be supplied.
 Drain Service
A 35mm sealed drain with an untapped 22mm entry, capable of withstanding steam at
136 ° C, with a constant fall to waste, vented at a high level outside of the building to
satisfy the requirements of BS 2646 Part 2 1990. A separately trapped, 22mm drain
should be provided for the Auto Water Fill tank. All drains should be provided at a low
level within 2 meters run of the rear of the Priorclave.[6]
Other considerations
 Number of loads per day.

 Manual load settings or pre-programmed.
 Installation and commissioning.
 Performance testing.
 Extended warranty / Service contracts.[7]
Options and accessories
 Vertical power doors are an option on front loading rectangular section autoclaves from
230 to 700 liter sizes
 Load-lite lifting hoist - helps out with heavy loads from top loading autoclaves
 Loading trolleys - to help roll loads in and out of front loading laboratory autoclaves
 Automatic waterfill - fills the autoclave between cycles (usually R.O. water)
 Air intake filter - filters air taken into the autoclave (standard with vacuum drying or
cooling cycles)
 Serial interface - for monitoring by computer
 Self-monitoring - TACTROL® continuously monitors itself for correct calibration
 Recorders - for independent monitoring. Load and pressure sensing channels available
 Waste containers - for operator safety and protection of your autoclave with waste loads.
These contain spillages whilst allowing good steam penetration
 Load baskets - check the maximum number of load baskets for your size of autoclave
The choice of an autoclave, such as those in the Priorclave range, can represent a big investment
financially and you want to make sure it performs to all your expectations and sterilizes your loads
safely and correctly.[6]
How to sterilize medical instruments
This short tutorial will provide the basics for proper preparation of instruments before sterilization.
Steps
1. Make sure the instruments are free from all residual matter, such as blood or organic
tissue. Instruments must also be dry and free from mineral deposits. Such substances may
cause damage to the instruments or sterilizer.
2. Clean instruments immediately after use. It is recommended that instruments be cleaned
using the Clean and Simple Ultrasonic Cleaning System.
3. After ultrasonic cleaning, rinse for 30 seconds and pat dry.
4. Follow the instrument manufacturer’s instructions for cleaning and lubricating
instruments.
5. Sterilize in an open position.
6. Place a sterilization indicator in each tray or inside each wrapped pack.
7. Make sure that all instruments remain apart during the sterilization cycle.
8. Place empty canisters upside-down in order to prevent accumulation of water.
9. Do not overload sterilizer trays. Overloading will cause inadequate sterilization &drying.
10. Allow a distance of about 1" between trays or cassettes to permit steam circulation.
11. Place wrapped instruments in material which will allow steam penetration and promote
drying, such as an autoclave bag, autoclavable paper, or muslin towels.
12. Do not stack pouches.[3]
Tips
 At least once per week use a biological spore test in any load to insure proper
sterilization. The spore test should be placed in an area that is the most difficult for the
steam to reach. (Be aware testing standards may vary) .
Warnings
 Be sure that instruments of dissimilar metals (stainless steel, carbon steel, etc.) are
separated. Carbon steel instruments should be bagged or placed on autoclavable towels
and not directly on stainless steel trays. (Mixing will result in the oxidation of those
metals.
 Check manufacturer's instructions as to the proper procedure for sterilizing each item.
The instrument manufacturer can give specific information on proper sterilization
temperature and sterilization time
 for any item.[3]
Types of autoclave loads
 Glassware, instruments & apparatus

Standard use of autoclave with option of vacuum drying which allows loads to be
removed 'dry' with out operator intervention
 Media preparation
The following options are recommended for effective media preparation with reduced
cycle times: freesteaming (improved temperature distribution); accelerated cooling (extra
loads per day); media warming (when cycle finishes media is kept at 40oC, handy for
overnight cycles); performance testing
 Fluid and diluents sterilization
Priorclave recommends the following options for effective fluid sterilization: load sensed
process timing (guaranteed sterilizing times as cycle does not start until probe placed in
centre of load reaches cycle temperature); accelerated cooling (extra loads per day).[7]
 Waste
The greatest difficulty with some waste loads is achieving adequate load steam
penetration especially where there are large volumes of air (petri dishes, porous loads,
etc.) and/or large quantities of insulating plastic materials. The following options are
recommended: freesteaming (improved temperature distribution); pulsed freesteaming
(improved steam penetration); accelerated cooling (more loads per day); pre-cycle
vacuum (excellent air removal in conjunction with pulsed freesteaming); vacuum cooling
cycle (even faster cycles); performance testing.
 Porous loads (e.g. textiles)
The key requirements are good steam penetration and effective drying. The following
options are strongly recommended: pulsed freesteaming (improved steam penetration) in
conjunction with pre-cycle vacuum for effective air removal; vacuum drying (essential
for load to be removed 'dry' at the end of the cycle).[6]
Health Care
Priorclave are well acquainted with the U.K. Health Service HTM2010 requirements and offer a
compliance package suitable for all their laboratory autoclaves. Their technical department are
well experienced in performance testing to HTM2010 requirements. Priorclave's calibration and
performance testing procedures are fully accredited by UKAS.
The HTM2010 compliance package includes the following:
 self-monitoring (TACTROL® control system continuously monitors itself for

correct calibration)
 mechanical cycle counter
 setting lock
 independent thermal lock
 pressure gauge test port.
Priorclave also recommend fitting a process printer for clear, automated record keeping and a
multi-programmed memory where more than one type of cycle is used.[6]
Automatic Autoclave Series
Tuttnauer Automatic Autoclaves produce the highest return on your investment by offering :
 Rapid cycles
 Low maintenance
 Durability
 Safety
Automatic Series Features:
 pre-set sterilization programs

 Program and customize cycle parameters to meet
your needs
 High precision control system for accurate sterilization results
 Integrated printer for cycle documentation (optional)
 PC Communication port enables storage of sterilization results
 Temperature and pressure monitoring
 User friendly, intuitive display
 Cycle information recovery in the case of power failure or cycle interruption
 Insufficient water detector with automatic shutoff
 Consistent monitoring of temperature and pressure for real- time accurate results
 Water-level sensors prevent cycle activation when insufficient water is detected in the
chamber or reservoir
Semi-Automatic Autoclave Series
The Semi-Automatic Autoclave is an affordable sterilizer for private clinics that do not want to
compromise on quality , safety and reliability.
Tuttnauer Semi-Automatic autoclaves are an effortless Plug n' Play solution. After installation,
the sterilizer is virtually maintenance free with reduced running costs.
Benefits:
 Tuttnauer Semi-Automatic Autoclaves last longer

 Durable components significantly reduce maintenance expenses
 Ease of use eliminates the need for specialized staff to operate sterilizer
These autoclaves don't just seem to be different; they are different.
Specially developed for sterilization procedures in the
laboratory,
processes become easier, safer, more precise,
and reproducible.
A new technique in locking doors …
Sterilizing process
Steam generator
Drying process
TSO3 has developed a unique, patented process to create and control ozone so that it can be used
to sterilize commonly used medical instruments. In a self-contained unit, ozone is generated,
circulated, and catalyzed back into oxygen – simply by pressing a single button.
Benefits
 Fast
 Safe for the environment
 Safe for heat and moisture-sensitive
instruments
 Large throughput
 Inexpensive to operate
 Reliable
 Safe for operator
 Easy to operate
Ozone technology
Ozone was discovered in 1840 and its water

purification properties were first recognized in
1886. A few years later, the first plant to use
ozone to treat drinking water was opened in the
Netherlands. Ozone water treatment plants are
very common in Europe and are gaining
popularity in North America. This expanding
acceptance is due both to ozone's superior
microbicidal properties and to people's concern
about the harmful effect that other microbicides,
like chlorine, have on the environment and on
human health. Ozone has also historically been
used to preserve meat and as a microbicide to
treat food.
Despite widespread recognition of the powerful

germ killing properties of ozone, it has not been
successfully used in healthcare settings in the
past due to the challenges associated with
creating and controlling it in a way that makes it
useful for hospitals .
www.sterilizers.com/aboutsterilizers.asp [1]
Provide you with all you need about sterilizer and sterilization .
en.wikipedia.org/wiki/Sterilizers.html [2]
The famous internet encyclopedia
www.wikihow.com/Sterilize-Medical-Instruments [3]
Want to find all your answers of questions begin with the expression " how " ?
may you look in this website .
www.wisegeek.com [4]
This website give the science geek wisdom for all .
www.laboratorytalk.com [5]
Educational website for all instruments in laboratory.
www.progensci.co.uk/page918/Laboratory-Autoclaves [6]
Educational and business website for all instruments in laboratory.
www.arab-eng.org/vb/t80147.html [7]
The famous internet club for engineers.
Standard references
BS 2646 Part 2 1990 Ventilation standard for equipment
EN 13445 & EN 14222 design & constructing European standards
EN 866–1, Biological systems for testing sterilizers and sterilization processes — Part 1: General
requirements.1
EN 866–5, Biological systems for testing sterilizers and sterilization processes — Part 5: Particular
systems for use
in low temperature steam and formaldehyde sterilizers. 2
EN 867–5, Non-biological systems for use in sterilizers — Part 5: Specification for indicator systems
and process
challenge devices for use in performance testing for small sterilizers Type B and Type S.
EN 868–5, Packaging materials and systems for medical devices which are to be sterilized — Parts 5:
Heat and
self-sealable pouches and reels of paper and plastic film construction — Requirements and test
methods.
EN 60584–2, Thermocouples — Part 2: Tolerances (IEC 60584–2:1982 + A1:1989).
EN 60751, Industrial platinum resistance thermometer sensors (IEC 60751:1983 + A1:1986).
EN 61010–1, Safety requirements for electrical equipment for measurement, control and laboratory
use — Part 1:
General requirements (IEC 61010-1:2001).
EN 61010–2–042:1997, Safety requirements for electrical equipment for measurement, control and
laboratory
use — Part 2–042: Particular requirements for autoclaves and sterilizers using toxic gas for the
treatment of
medical materials, and for laboratory processes (IEC 61010–2–042:1997).
EN 61326:1997, Electrical equipment for measurement, control and laboratory use — EMC
requirements
(IEC 61326:1997).
EN ISO 3746, Acoustics — Determination of sound power levels of noise sources using sound
pressure — Survey
method using an enveloping measurement surface over a reflecting plane (ISO 3746:1995).
HTM2010 U.K. Health Service requirements which offer a compliance package suitable for all
their laboratory autoclaves
ISO 228–1, Pipe threads where pressure-tight joints are not made on the threads — Part 1:
Dimensions, tolerances and designation.
Terms and definitions

For the purposes of this European Standard, the following terms and definitions apply.
access device
means used to enable access to restricted parts of equipment
NOTE This may be a dedicated key, code or tool.
aeration
a part or parts of the sterilization process in which defined conditions are used such that formaldehyde
and its
reaction products are desorbed from the medical device, and which can be performed within the
sterilizer, within a
separate room or chamber, or by a combination of the two
air removal
removal of air from the sterilizer chamber and sterilization load to facilitate sterilant penetration
automatic controller
device that, in response to pre-determined cycle variables, operates the sterilizer sequentially through
the required
stages of the operating cycle
1 Under revision, see new edition of ISO 11138 series which is currently being prepared by ISO/TC 198, Vienna
Agreement.
2 Under revision, see new edition of ISO 11138 series which is currently being prepared by ISO/TC 198, Vienna
Agreement.
CDC (Center for Disease Control) Public health organization in the United States that
researches contagious diseases
biological indicator
an inoculated carrier contained within its primary pack ready for use
[EN 866–1:1997, definition 3.1]
chamber pre-heating
the heating of inner sterilizer-chamber surfaces to achieve predetermined temperatures prior to the
commencement
of a sterilization cycle
conditioning
treatment of product within the sterilization cycle, but prior to the holding time, to attain a
predetermined
temperature and humidity throughout the sterilization load
cycle complete
indication that the operating cycle has been satisfactorily completed and that the sterilized load is ready
for removal
from the sterilizer chamber
[EN 285:1996, definition 3.10]
cycle parameter
specified value for a cycle variable
cycle variables
the physical properties that influence the efficacy of the sterilization cycle
NOTE For LTSF-sterilizers, the cycle variables include, but may not be limited to temperature, pressure, time,
sterilant
concentration.
desorption
removal of the sterilant from the chamber and the load at the end of the exposure time
double-ended sterilizer
sterilizer in which there is a door at each end of the sterilizer chamber
equilibration time
period which elapses between the attainment of the sterilization temperature at the reference measuring
point and
the attainment of the sterilization temperature at all points within the load
exposure time
time between introducing the sterilant into the chamber and the start of the desorption phase
Geobacillus stearothermophilus
Spores of a heat-resistant bacterium
holding time
period for which the temperature, the steam pressure and the formaldehyde concentration of the steam
are held
within pre-set values and their tolerances to achieve the required inactivation efficacy in the sterilizer
chamber
NOTE The holding time follows immediately after the equilibration time.
inoculated carrier
a carrier on which a defined number of test organisms has been deposited
[EN 866-1:1997, definition 3.8]
installation qualification
IQ
obtaining and documenting evidence that equipment has been provided and installed in accordance
with its
specification
[EN ISO 14937:2000, definition 3.9]
loading door
door in a double-ended sterilizer through which the sterilizer load is put into the sterilizer chamber
prior to
sterilization
[EN 285:1996, definition 3.21] (See also 3.43 unloading door)
medical device
any instrument, apparatus, appliance, material or other article, whether used alone or in combination.
microbicidal solution
aqueous solution containing formaldehyde to feed the vaporizer for generating sterilant in the sterilizer
operating cycle
the automatic sequence of operating stages performed in a sterilizer
[EN 1422:1997, definition 3.24]
operational qualification
OQ
process of obtaining and documenting evidence that installed equipment operates within predetermined
limits when
used in accordance with its operational procedures [EN ISO 14937:2000, definition 3.12]
operator
person operating equipment for its intended purpose
override
means intended only for maintenance or safety, by which the operating cycle can be interrupted or
modified
Porous
Full of pores , able to absorb fluids
post-cycle flushing
stage after "cycle complete" indication, during which the sterilization load is left in the closed chamber
and the
internal chamber atmosphere is exchanged
pressure vessel
a vessel consisting of the sterilizer chamber, door(s) and other components that form a permanent unit
with the
sterilizer chamber and that are pressurized by the same pressure
process challenge device
item designed to simulate product and used to assess the penetration performance of the sterilization
cycle
NOTE The device is so constituted that a biological or chemical indicator can be put in the place which is the most
difficult
to reach by sterilizing agent(s).The indicator should not interfere with the function of the process challenge device.
production test
series of tests performed to demonstrate compliance of each sterilizer with its type test performance
reference measuring point
the point where the temperature sensor for the sterilization cycle control is located
requalification
repetition of part of validation for the purpose of confirming the continued acceptability of a specified
process
R-O Read Only
RS Recommended Standard
Solenoid a coil of wire around an iron core

sterilant
microbicidal agent composed of steam containing formaldehyde
sterilant injection
single or repeated stage beginning with the introduction of sterilant into the evacuated sterilizer
chamber and
ending when the set operating pressure has been attained
sterile
free from viable micro-organisms
sterilization
validated process used to render a product free from viable micro-organisms
NOTE In a sterilization process the nature of microbial inactivation is described by an exponential function.
Therefore the
presence of a viable micro-organism on any individual item can be expressed in terms of probability. This
probability may be
reduced to a very low number, it can never be reduced to zero.
sterilizer
apparatus designed to achieve sterilization[EN 285:1996, 3.36]
sterilizer chamber
that part of the sterilizer, which receives the sterilizer load
sterilization cycle
predetermined sequence of operating stages performed in a sterilizer for the purpose of sterilization and
desorption
sterilization load
items that are to be, are being or have been sterilized simultaneously in one sterilizer chamber
sterilization process
series of actions or operations to achieve the specified requirements for sterility and for reduction of
sterilant
residues to an acceptable level
NOTE This series of actions or operations includes pre-treatment (if necessary), exposure to the sterilizing agent
under
defined conditions, and any necessary post-treatment. It does not include any necessary operations preceding the
sterilization
process, such as cleaning, disinfection or packaging.
sterilization temperature
minimum temperature of the sterilization temperature band on which the evaluation of the sterilization
efficacy is
based
sterilization temperature band
temperature tolerance range for the load and the reference measuring point, the minimum of which is
the
sterilization temperature
theoretical sterilant temperature
the temperature of the sterilant, calculated from the temperature versus vapor pressure relationship of
the sterilant
NOTE This value is calculated from the beginning of the exposure time until the beginning of aeration.
TACTROL®
Control system continuously monitors itself for correct calibration
unloading door
door in a double-ended sterilizer through which the sterilizer load is removed from the sterilizer
chamber after a sterilization cycle [EN 285:1996, definition 3.42] (See also 3.18 loading door)
UKAS
United Kingdom Accreditation Service
usable space
space inside the sterilizer chamber, which is not restricted by fixed parts and which is, according to the
manufacturer’s specification, available to accept the sterilization load .
validation
documented procedure for obtaining recording and interpreting the results required to establish that a
process will
consistently yield product complying with predetermined specifications
Annex (A)
1 Technical requirements
1.1 Sterilizer chamber
1.1.1 Materials
1.1.1.1 The surfaces of the materials for the pressure vessel (including, for example, welds) that can
come into
contact with process chemicals shall be of materials which, under the designed operating conditions,
are not
impaired by these chemicals. They shall not release any substances known to be toxic in such quantities
that can
create a health or environmental hazard.
NOTE In the selection of materials for pressure parts and their integral attachments, due attention should be paid to
the
effects of contact corrosion and differential expansion when dissimilar metals are used in contact.
1.1.1.2 Materials for sterilizer furniture including load supporting systems shall be selected to avoid
corrosion
and galvanic attack.
1.1.2 Chamber size
For the usable space the following dimensions shall be specified in millimeters, as applicable:
a) For cylindrical horizontal or cylindrical vertical usable spaces: 000 x 000 in which:
the first three digits give the diameter of the usable space; and
the last three digits give the depth of the usable space.
b) For rectangular parallelepiped usable spaces: 000 x 000 x 000 in which:
the first three digits give the width of the usable space;
the next three digits give the height of the usable space; and
the final three digits give the depth of the usable space.
c) For other configurations the usable space shall be specified in analogy to a) or b).
d) If any dimension exceeds 1000 mm then four digits shall be used, without a decimal point.
1.1.3 Doors and interlocks of the sterilizer chamber
1.1.3.1 Sterilizer chambers shall be provided with one or two doors.
1.1.3.2 After closing the sterilizer door, it shall be possible to open it before a cycle has been started.
1.1.3.3 It shall not be possible to open a sterilizer door(s) during a cycle.
1.1.3.4 In case of an interrupted cycle (e. g. due to a fault), opening of the sterilizer door e. g. to gain
access to
the load shall require the use of an access device.
1.1.3.5 Means shall be provided to allow access to sealing surfaces for cleaning purposes and for
replacing
the door seal(s).
1.1.3.6 For double-ended sterilizers it shall not be possible to open the unloading door until a "cycle
complete"
indication is obtained.
1.1.3.7 For operating cycles dedicated for test or maintenance purposes only, the cycle complete
indication
shall be different from that of a normal sterilization cycle. For double-ended sterilizers such cycle
complete
indications shall not permit the unloading door to be opened.
1.1.3.8 The control used to start the automatic operating cycle shall be located at the loading side of the
sterilizer.
1.1.3.9 Except for maintenance purposes it shall not be possible to open both doors simultaneously on
double ended
sterilizers.
1.1.3.10 For double-ended sterilizers both ends of the sterilizer shall be fitted with a device to indicate
whether
the door at that end can be opened.
1.1.3.11 The indication "cycle complete" shall be cancelled when a door is opened. For double-ended
sterilizers
the loading door shall remain locked until the unloading door has been opened, closed and locked
again.
1.1.4 Heating the sterilizer chamber
Inner sterilizer chamber surfaces shall be heated to achieve pre-set temperatures. Initiation of the
sterilization cycle
shall not be possible until this condition has been fulfilled.
1.1.5 Test connections
1.1.5.1 The sterilizer chamber shall be provided with a test connection, which is used for the
connection of a
test pressure measuring instrument. This connection shall be at a point of easy access, but not in a pipe
for media
transport or evacuation, and shall terminate in a pipe thread ISO 228 –G1/2A.
The test connection shall be provided with a cap marked PT (Pressure Test) and sealed with a sterilant
proof and
mechanically resistant O-ring seal or flat seal.
NOTE If national regulations require the calibration of all pressure instruments connected to the pressure vessel,
test tees
and valve cocks with sealing plugs may be required to permit connection of reference instruments.
1.1.5.2 The sterilizer chamber shall be provided with a straight thermometry entry connection.This
connection shall be at a point of easy access.
The connection shall be provided with a cap marked TT (Temperature Test) and sealed with a sterilant
proof and
mechanically resistant O-ring seal or flat seal.
1.2 Design and construction
1.2.1 General
A Council Directive on the approximation of the laws of the member states concerning pressure
equipment was
released on 29 May 1997 (97/23/EC) and corresponding European Standards EN 13445 and EN 14222,
may
apply.
1.2.2 Pipework and fittings
1.2.2.1 Pipeworks and fittings (including e. g. seals) which may come into contact with process
chemicals shall
be of materials which, under the designed operating conditions, are not impaired by these chemicals.
They shall
not release any substances known to be toxic in such quantities that can create a health or
environmental hazard.
NOTE To avoid heat loss or condensation, all pipework carrying media to the sterilizer should be isolated except
where this
will interfere with the function of the sterilizer.
1.2.2.2 Connections for water and steam supply and drainage shall be provided with means to prevent
the
ingress of particles which could affect the performance of a sterilizer.
NOTE For connections to potable water supply and draining, national or local regulations may apply.
1.2.2.3 Pipework shall be designed to prevent accumulation of condensate.
1.2.2.4 All control valves in the pipework shall be marked with permanent identification in relation to
their functions
1.2.3 Evacuation system
1.2.3.1 Sterilizers shall be provided with a vacuum system to remove air, water and sterilant. The
lowest
absolute pressure needed for fulfilling the requirements of clause 6 when tested according to A.3 shall
be specified.
NOTE Vacuum systems mostly operate by means of water. Attention should be paid to optimize the use of water
in such
systems, as there could be a balance between the use of resources and diluting of formaldehyde into concentrations
harmless
to environment .
1.2.3.2 The sterilizer shall be provided with a means for leak testing which shall include the sterilizer
chamber
and all relevant connected pipework and fittings.
At leak testing the chamber and relevant pipework shall be evacuated to or below the lowest process
pressure. The
pressure rise shall not exceed 0,1 kPa/min over a period of not less than 5 min and not more than 15
min after
obtaining the lowest pressure.
1.2.4 Electrical and mechanical safety
1.2.4.1 For general design, EN 61010–1 and EN 61010–2–042 shall apply.
NOTE For guidance regarding specific design aspects, EN 60204–1 may apply. The guidance in EN 60204–1
may reduce
testing.
1.2.4.2 Sterilizers shall comply with EN 61326 regarding electromagnetic compatibility (EMC).
Sterilizers operating either in areas in which medical electrical equipment is intended to be used or in
the vicinity of
other sensitive equipment shall be regarded as class B equipment as specified in EN 61326.
For immunity, the testing requirements in EN 61326:1997, Table A.1 shall apply.
For the selection of immunity testing performance criteria, the general guidance of EN 61326 applies.
The selected performance criteria shall ensure that the sterilizer performance as specified in 5.2 will be
met during
normal operation, when exposed to disturbance phenomena given in EN 61326:1997, Table A1.
1.2.5 Aeration system
1.2.5.1 When the sterilizer chamber is ventilated during the aeration for the purpose of desorption and
to
release the vacuum at the end of the process, microbial recontamination of the sterilization load shall be
prevented.
1.2.5.2 When a filter is fitted to the sterilizer to prevent microbial recontamination during aeration or
pressure
equalization, it shall be readily accessible for replacement. The filter shall be capable of retaining at
least 99,5 % of
particles with a diameter of 0,3 μm at a pressure difference of 1 bar and at maximum airflow.
Means shall be provided between the filter and the sterilization chamber to prevent fluid flow from the
sterilizer
chamber into the filter.
1.2.6 Framework and paneling
1.2.6.1 If the sides of the sterilizer need not to be accessible for normal operation, they shall be
enclosed with
paneling.
NOTE 1 Sterilizers designed to be recessed into existing walls providing continuous joint with the sterilizer front
paneling, do
not need to be provided with side paneling.
The paneling shall be long-term corrosion-resistant. Instructions for cleaning of the paneling shall be
provided.
NOTE 2 Ventilation openings may be provided in the paneling.
1.2.6.2 The paneling of sterilizers shall allow access for maintenance work.
NOTE The access for maintenance should be positioned so that it will not compromise the safety of either the
product or
persons. Requirements for access are specified in EN 61010–2–042.
1.3 Indicating, measuring, operating and recording devices
1.3.1 General
1.3.1.1 Indicating and operating devices shall be identified as to their function. They shall be readily
accessible, clearly and durably marked with their function and designed to be easy to operate and read.
1.3.1.2 The devices shall be positioned and/or protected such that their performance is within the
specified
tolerances during the operation of the sterilizer.
1.3.1.3 If an indicating instrument is connected in turn to more than one sensing point, there shall be a
continuous indication of the active sensor that is being monitored.
1.3.1.4 Indicating and operating devices shall be readable when viewed at a distance of (1±0,15) m
with
normal or corrected vision in an illumination of (215±15) lx.
1.3.1.5 Indicating, measuring and recording devices shall have means to adjust in situ by the use of an
access device without dismantling the instrument. For analogue indicating instruments that are not
easily
demountable, means for adjustment in situ shall be provided.
NOTE Where digital pressure indicators are used, an additional mechanically attached indicator may be required
to comply
with national pressure vessel regulations. Where an analogue instrument is provided only for this purpose, the
requirement for
adjustment in situ is waived.
1.3.1.6 Additional functions fitted at recording or indicating devices shall not jeopardize the accuracy
of
registration or indication.
1.3.2 Temperature measuring devices
1.3.2.1 When used for process control, monitoring or registration purposes, temperature measuring
devices
shall have maximum permissible errors of 1 K or less over the scale range 20 °C to 100 °C and be
adjusted to
± 0,5 K or less at the sterilization temperature.
1.3.2.2 Temperature control systems shall be protected against unauthorized operation by the use of an
access device.
1.3.2.3 At least two independent sensors shall be used for the measurement of the chamber
temperature,
being dedicated to indication, control and registration. The sensors shall be located in the most
representative
position in the chamber specified as being the reference measuring point.
1.3.2.4 The registration and monitoring/controlling devices shall be mutually independent as given by
any of
1.3.2.5 The temperature sensor including the measuring system it is connected to shall have a response
time
τ0,9 < 5 s when tested in flowing water according to EN 60751.
1.3.2.6 Temperature control systems shall have a function which causes a fault to be indicated if a
sensor
fails.
1.3.3 Temperature indicating devices
In addition to the requirements in 4.3.2.1, the temperature indicating devices shall:
 be graduated in degrees Celsius;
have a scale, which includes 0 °C to 100 °C;
 for analogue instruments be graduated in divisions not greater than 2 °C;
 for digital instruments have a resolution of at least 0,1 °C.
Figure 1 — Arrangements for temperature and pressure sensors
1.3.4 Pressure measuring and indicating devices

1.3.4.1 When used for control, monitoring or registration purposes, pressure measuring and indicating
systems shall be protected against unauthorized operation by the use of an access device.
1.3.4.2 When used for process control, monitoring or registration purposes, absolute pressure
measuring
systems shall be used.
1.3.4.3 At least two independent sensors shall be used for the measurement of the chamber pressure,
being
dedicated to indication, control and registration.
1.3.4.4 The registration and monitoring/controlling devices shall be mutually independent as given by
any of
1.3.4.5 When used for process control, monitoring or registration purposes, pressure measuring and
indicating
chain shall have maximum permissible errors of 1 % or less over the scale range, and be adjusted to ±
0,8 kPa (±
0,008 bar) or less over the range from 0 kPa (0 bar) up to the sterilization pressure.
1.3.4.6 When used for process control, monitoring or registration purposes, pressure measuring systems
shall
have a function which causes a fault to be indicated if a sensor fails.
1.3.4.7 Pressure indicating devices shall:
 be graduated in kilopascals or bars;
have a scale which includes the range 0 kPa (0 bar) to at least 10 % above the maximum process
operating
pressure when used for process control or monitoring purposes;
have maximum permissible errors as specified in 4.3.4.5 when used for process control or
monitoring
purposes or have maximum permissible errors of 1,6 % or less over the scale range at others;
 for analogue instruments, be graduated in divisions not greater than 5 kPa (0,05 bar) when used for
process
control or monitoring purposes and in divisions not greater than 20 kPa (0,2 bar) at others;
 for analogue instruments indicating overpressure, have the maximum allowable operating pressure
legibly
identified;
 for digital instruments, have a resolution of not greater than 0,5 kPa (0,005 bar) and be adjusted to
better than
0,8 kPa (0,008 bar) from 0 kPa (0 bar) to the sterilization pressure.
1.3.5 Timers and time indicating devices
1.3.5.1 A timer shall control the holding time.
1.3.5.2 Time periods within the process shall have an uncertainty of measurement of ±1,0 s or less.
1.3.5.3 If dates and times are indicated, the formats yy:mm:dd and hh:mm:ss shall be used as
applicable.
1.3.5.4 The time period of each time controlled part of the sterilization cycle shall be adjustable by the
means
of an access device.
1.3.5.5 Means shall be provided, independent of the process control, to verify the time period of each
stage of
the sterilization cycle.
1.3.6 Sterilizing cycle counter
A counter shall be provided to indicate the cumulative number of all operating cycles started, including
those cycles
in which a fault occurred. The cycle counter shall display a minimum of four digits and shall not be
capable of being
reset inadvertently or deliberately.
1.3.7 Recording instruments
1.3.7.1 General requirements
1.3.7.1.1 The recorder shall be independent such that the measuring chain as well as value data
processing and
printed values are separate from the automatic controller.
NOTE 1 This does not exclude the transfer of informative data from the automatic controller to the recorder and
vice versa,
via a combined system for data transfer.
NOTE 2 Sterilizer identification, cycle number and load identification may be recorded automatically.
1.3.7.1.2 For operational inspection as well as for batch documentation, analogue or digital recorders
shall
record pressure and temperature data versus time. The records shall allow evaluation of the data for
compliance
with specified temperature and pressure profiles throughout the operating cycle (see 9.2 a)).
NOTE The data printed may consist of digital records, analogue curves or both.
1.3.7.1.3 The recorder shall produce a record, which shall be readable as defined in 1.3.7.1.6 when
stored in
specified conditions for a period of not less than 10 years.
1.3.7.1.4 Unless the power supply is interrupted or the instrument itself malfunctions, the instrument
shall
continue to operate after a fault occurs.
1.3.7.1.5 Recorders shall have a sampling interval of 2 s or lower for each channel.
1.3.7.1.6 Records shall be readable when viewed at a distance of (250±25) mm with a normal or
corrected
vision in an illumination of (215±15) lx.
1.3.7.1.7 If times are marked, units shall be either in seconds, minutes or hours or multiples thereof.
Time
periods up to 5 min shall have an uncertainty of measurement of ±2,5 % or less and for periods above 5
min of
±1 % or less.
1.3.7.1.8 Means shall be provided to adjust the recorder in situ by the use of an access device.
1.3.7.2 Recorders producing analogue records
1.3.7.2.1 Recorders producing analogue records shall have a chart speed of not less than 2 mm/min.
1.3.7.2.2 If two or more variables are recorded on the same chart, the printed scale markings on the
chart shall
be common for all the variables recorded and the major marked interval shall be marked sequentially
for each of
the variables recorded.
1.3.7.2.3 Recorders producing analogue records shall have a minimum scale width of 100 mm.
1.3.7.2.4 Temperature recorders producing analogue records shall:
have a chart graduated in degrees Celsius;
have a scale, which includes the range 0 °C to 100 °C;
have maximum permissible errors of 1 % or less over the scale range 0 °C to 100 °C;
 be adjusted to ±1 °C or less at the sterilization temperature.
1.3.7.2.5 Pressure recorders producing analogue records shall:
have a chart graduated in bars or kilopascals;
have a scale which includes the range 0 kPa (0 bar) up to the maximum process operating pressure;
have maximum permissible errors of the record of 1,6 % or less over the scale range
 be adjusted to 1,0 kPa (0,01 bar) or better over the scale range.
1.3.7.3 Recorders producing digital records
1.3.7.3.1 Recorders producing digital records shall use alphanumeric characters and define data by text.
1.3.7.3.2 Recorders producing digital records shall have a paper width with a space for a minimum of
15 characters/line.
1.3.7.3.3 Temperature recorders producing digital records shall:
have a range which includes 0 °C to 100 °C;
have maximum permissible errors of 1 K or less over the range 20°C to 100°C.
1.3.7.3.4 Pressure recorders producing digital records shall:
have a range which includes 0 kPa (0 bar) to at least 10 % above the maximum process operating
pressure;
have maximum permissible errors of the record of 1,0 % or less over the scale range.
1.3.8 Indications and registrations
1.3.8.1 Sterilizer instrumentation shall make available to the operator at least the following visual
information:
a) indication of the chamber pressure;
b) indication of the chamber temperature;
c) registration of the chamber temperature independent from the automatic controller;
d) registration of the chamber pressure independent from the automatic controller;
e) indication of the chamber wall temperature;
f) indication of the pressure or temperature of the formaldehyde vaporizer (for indication of the
vaporization
ability);
g) indication of the jacket pressure if the sterilizer is fitted with a pressurized jacket;
h) indication of steam supply pressure if dedicated steam generator is used;
i) indication of the sterilizer being in the state of alert (standby);
j) indication of sterilizer “door(s) locked”;
k) indication of the sterilization cycle selected;
l) indication of sterilizer “in progress”;
m) indication of the sterilization cycle stage;
n) indication of "cycle complete";
o) indication of "fault" when occurring (see 5.4);
p) indication of when the sterilizer door can be opened;
q) cycle counter.
NOTE 1 Items c), d) and q) may be incorporated into a single recording system.
NOTE 2 Except where required in EN 61010–2–042 the items a), b), e), f), g) and h) may be incorporated into a
system
whereby the user may select the display of any measurement.
NOTE 3 Item m) cycle stage indication may incorporate items i), j), l), n) and p).
1.3.8.2 In addition, instrumentation at double-ended sterilizers shall provide the following visual
information at
the unloading side:
a) indication of the chamber pressure;
b) indication of sterilizer “in progress”;
c) indication of "cycle complete";
d) indication of when the unloading door can be opened;
e) indication of "fault".
2 Process control
2.1 General
2.1.1 The sterilizer shall be operated by an automatic controller, which has one or more pre-
set sterilization
cycles.
2.1.2 The sterilizer shall operate with pre-set programs permanently stored in the automatic
controller. Any
change of the pre-set program or its parameters shall require the use of an access device.
NOTE Automatic loading and unloading may be initiated without the use of an access device.
2.1.3 The variables and parameters programmed into the automatic controller and the
tolerable limits that will still
enable the performance requirements of clause 6 to be met shall be specified. (See also 9.2
a)).
2.1.4 The automatic controller shall be protected against short circuit in components or
equipment, which are
directly or indirectly connected to the controller.
NOTE 1 Guidance is given in EN 60204–1.
NOTE 2 Verification may be achieved by assessing compliance with EN 60204–1.
2.1.5 The automatic controller shall be located such that the maximum values of temperature
and humidity
specified for the automatic controller are not exceeded.
NOTE Normally the temperature and humidity in the vicinity of the control system should not exceed 50
°C and 85 %
relative humidity respectively.
2.1.6 The automatic controller shall have status indicators for each digital inputs and outputs.
NOTE These can be located within the enclosure of the controller.
2.1.7 The reference measuring point shall be selected in such a way that throughout the
holding time the
temperature at this point correlates with the temperature in the usable space.
2.2 Sterilization cycle and automatic control
2.2.1 Leak testing shall be performed either during the first vacuum phase or during the
complete holding time.
For process control, if the test is carried out during the first vacuum phase, a pressure
stabilizing time not
exceeding 15 min may precede the test period.
The pressure change measured shall be 50 Pa (0,5mbar) per minute when tested over a
period of 10 min.
A pressure rise due to media injection during the holding time shall not be considered as a
leak for the evaluation
of the leak rate.
There shall be a visual and/or audible indication if the test fails. The process shall be
interrupted automatically by
aeration and, in case the sterilant has already been injected, the desorption process shall be
started immediately.
2.2.2 The parameters identified during process development as critical to the sterilization
cycle shall be
reproducible within the limits identified in 2.1.3. This shall be demonstrated by the tests
specified in Table B.1.
2.2.3 Means shall be provided to ensure that the specified amount of microbicidal solution has
been supplied to
the vaporizer and has been vaporized.
2.2.4 The automatic controller shall ensure that all chemical/physical conditions necessary for
the efficacy and
reproducibility of the sterilization cycle are achieved throughout the specific periods.
NOTE Ab-/adsorption of formaldehyde to the load and formation of paraformaldehyde may reduce the
concentration of
vaporised formaldehyde in the chamber during the process.
2.2.5 The sterilization cycle shall include a desorption phase (see 6.2 and EN 61010–2–042).
2.2.6 The stage advance system of the automatic controller shall ensure that during a
sterilization cycle,
switching from one process stage to another will only be possible when the values required
for advance have been
attained.
2.2.7 An automatic post cycle flushing shall run or be repeated until the unloading door is
opened for removal of
the sterilizer load. This flushing-sequence shall be continuous or otherwise ensure that when
opening the
unloading door, the formaldehyde concentration in the chamber and load does not constitute
a hazard to human
beings or environment.
NOTE 1 Desorption of condensate residuals from the sterilized load may continue when the sterilized
load is left in the
sterilizer chamber.
NOTE 2 In order to maintain this ability a separate maintenance process may be recommended to
remove accumulated
formaldehyde residuals from the sterilizer chamber and piping (see 6.2 a)).
Figure 2 Example of a LTSF sterilization process
Key a Sterilization process

1 Cycle start b Operating cycle
2 Start sterilant injection c Sterilization cycle
3 Flushing within cycle d Exposure time
4 Cycle complete indication e Equilibration time
2 Post-cycle f Pre-heating
6 Cycle complete indication at delayed door opening/unloading g Air removal and conditioning
7 Removal of sterile goods h Holding time
8 Ambient pressure i Desorption
j Aeration
2.3 Override of automatic control
2.3.1 For maintenance, test purposes and in cases of emergency, means shall be provided to
permit manual
progression of the automatic controller.
NOTE Additional requirements regarding intervention safety and environmental aspects are specified in
EN 61010–2–042.
2.3.2 If an operator selectable control or other means to abort a sterilization cycle is provided,
its use shall cause
a fault to be indicated.
2.4 Fault
2.4.1 If a fault is caused by a power failure the requirements in 2.4.2 to 2.4.8 shall apply after
restoration of the
power supply.
2.4.2 If the cycle variables or parameter values are outside the limits specified by the
manufacturer (see 2.2.2) or
a failure of a service occurs sufficient to prevent the attainment of these variables, the
automatic controller shall:
a) cause an audible and/or a visual indication that a fault has occurred;
NOTE EN 61010–2–042 may require both in some cases.
b) stop its normal sequential switching from the process stage to the next;
c) cause a visual indication of the sterilization cycle stage at which the fault has occurred.
2.4.3 After a fault has been indicated the automatic controller shall either:
a) permit automatic completion of all remaining stages of the sterilization cycle, at which there
shall be no
indication of cycle complete, or;
b) permit automatic progress to the sterilant removal stage, followed by automatic progression
through the
remaining stages of the sterilization cycle, with no indication of cycle complete, or;
c) allow manual progression through the cycle to a safe condition with no indication of cycle
complete.
NOTE Additional safety requirements regarding faults are given in EN 61010–2–042.
2.4.4 The visual display indicating that a fault has occurred shall continue at least until the
release of the loading
door locking mechanism.
2.4.5 If a fault occurs after the formaldehyde injection has been started, the controller shall
ensure that the
sterilizer chamber cannot be opened until the formaldehyde has been sufficiently removed
from the chamber (see
also EN 61010–2–042).
2.4.6 If a fault occurs prior to or during the sterilization phase, the load is considered non-
sterile and the control
shall ensure that for double-ended sterilizers the unloading door cannot be opened.
2.4.7 If the sterilizer is fitted with a printer, the indication of a fault shall also be distinguishable
from the normal
printing e.g. by inverse printing.
2.4.8 After completion of a faulty cycle, access to the sterilizer load shall require the use of an
access device.
3 Performance requirements
3.1 Sterilizing performance
3.1.1 Physical parameters
3.1.1.1 Pre-heating
When tested as described in A.3.2.1, the temperature of the heated internal surfaces of the
sterilizer chamber shall
comply with the specifications given by the manufacturer.
3.1.1.2 Sterilization temperature band
The sterilization temperature band shall not exceed 4 K.
3.1.1.3 Temperature profile
During testing according to annex A, the following temperatures shall be used for the
evaluation of the temperature
profile:
the temperature measured at the reference measuring point;
the theoretical sterilant temperature as calculated from the corresponding prevailing
chamber pressure;
the temperatures in positions as specified in A.3.2.2 and A.3.2.3.
3.1.1.4 Temperature profile requirements
Throughout the sterilization cycle the temperature at the reference measuring point shall not
exceed the upper limit
of the sterilization temperature band.
During the cycle, until any aeration sequence is introduced, the theoretical sterilizing
temperature shall not exceed
the upper limit of the sterilization temperature band.
The equilibration time shall not exceed 60 s before entering the holding time.
During the holding time the temperatures as specified in 3.1.1.3 shall:
be within the sterilization temperature band;
not differ from one another by more than 2 K.
Compliance shall be tested according to A.3.2.2 and A.3.2.3.
3.1.1.5 Pressure profile
The pressure profile is evaluated by measurement of the sterilization cycle pressure. The
measurement shall
include limiting values to establish the profile of all sequences as well as data sufficient to
evaluate tolerances and
the rate of pressure change in applicable parts of the sterilization cycle. The result shall be
compared with
corresponding specifications stated by the manufacturer (see 9.2 a) 1)).
Pressure measurement for the evaluation of the pressure profile shall be barometrically
compensated.
3.1.1.6 Pressure profile requirements
Throughout the sterilization cycle the pressure profile and limiting values specified for the
pressure profile shall be
attained.
The maximum rate of pressure change measured shall not exceed 1000 kPa/min (10 bar/min)
when measured
over a period of 3 s.
NOTE 1 Pressure changes exceeding 1000 kPa/min (10 bar/min) may damage the package.
During the holding time the pressure profile shall be kept within the tolerances specified.
NOTE 2 There is a close relation between the pressure profile and the temperature profile in the
sterilizer chamber
throughout the holding time.
Compliance shall be tested according to A.3.4.1 and A.3.4.2.
3.1.1.7 Sterilant
The physical and chemical control parameters for the supply of sterilant to the process (e.g.
temperature, partial
pressure, concentration), as verified during process development and stated in the manual
(see also 9.2 a), shall
be achieved reproducibly within the pre-set values and tolerances.
3.1.2 Lethality (Microbiological efficacy)
When tested in accordance with A.3.3, the sterilization cycle shall ensure that exposed
biological indicators are no
longer viable when subjected to the culture conditions as specified for these indicators.
Untreated biological
indicators shall be viable when cultured in the same manner.
3.2 Desorption efficacy
The removal of formaldehyde from the sterilizer chamber and load at the desorption stage of
the operating cycle
shall ensure that the maximum stipulated concentration of formaldehyde in environment or
in/on processed items
will not be exceeded when the load is removed from the sterilizer.
NOTE 1 In many countries national regulations exist limiting formaldehyde concentration in air. These
regulations restrict
emission of formaldehyde to air from LTSF sterilizers.
NOTE 2 The complete removal of formaldehyde residuals from the sterilizer chamber and piping may in
addition to the
normal sterilization cycle require a separate maintenance process or procedure to be used periodically
(see 9.2 a)).
When tested in accordance with A.3.5, the desorption stage of the sterilization cycle shall be
able to reduce the
value of formaldehyde residues in/on processed items as follows:
The mean value calculated for test pieces of the same test load shall not exceed 200 μg.
The peak value for any single test piece shall not exceed 250 μg.
These values are valid for indicators with a diameter of 70 mm. For indicator diameters
differing from 70 mm the
figures shall be compensated proportionally to the change in surface area.
3.3 Drying
The sterilization cycle shall ensure that no packages in the sterilized load are wet when
unloading, and that any
remaining water droplets of the inner side of wrappings shall be evaporated within 5 min.
Compliance shall be tested according to A.3.6.
4 Sound power
The mean and the maximum sound power levels generated by the sterilizer shall be
specified, expressed as an A weighted
sound power level calculated as described in EN ISO 3746.
NOTE 1 For sound power generation of accessories necessary for sterilizer operation see 9.1 h).
No maximum value of the A-weighted sound power level shall exceed the mean A-weighted
sound power level by
more than 15 dB(A).
NOTE 2 See also EN 61010-1 for requirements on maximum sound pressure.
If changes or modification of tested equipment have previously been identified as not
contributing more than
3dB(A) to the total sound power level, further testing and change of the specification can be
omitted.
5 Marking and labeling
5.1 A Council Directive on the approximation of the laws of the member states concerning
pressure equipment
was released on 29 May 1997 (97/23/EC) and corresponding European Standards see EN
13445 and EN 14222,
are available.
These standards establish marking requirements for pressure vessels.
5.2 Markings and labels shall be permanently and legibly marked.
5.3 Markings regarding safety and environmental aspects are specified in EN 61010–2–
042:1997, 5.1, 5.2
and 5.3.
5.4 Other permanent and legible markings shall include at least:
a) manufacturer’s/suppliers identification;
b) unique identification number;
c) model identification;
d) production year;
e) for manual operated sterilizer doors, instructions describing the manual action required to
operate the door;
NOTE 1 These instructions can be displayed on the door, adjacent to the door, or on the operator's
control panel.
f) symbols/marking labels for indicating and operating devices;
NOTE 2 The explanation of such symbols/labels can be included in labeling or attached in user
instructions.
g) control valve identification.
6 Information to be supplied by the manufacturer
6.1 Before installation of the sterilizer, at least the following information shall be provided to
the purchaser:
a) installation instructions including overall dimensions and overall mass of the sterilizer as
well as the clearance
required for operational and maintenance access to the sterilizer;
b) details of services required for supply, drainage and ventilation;
c) details of the microbicidal solution and sterilant required for the sterilization, including
composition, safety data
sheet and storage requirements;
d) details of maximum consumption of microbicidal solution per sterilization cycle;
e) the total heat in watts transmitted to the surrounding air when the sterilizer is operated in
an ambient
temperature of (23±2) C in still air;
NOTE When designing the ventilation system the user should be aware of the heat transmitted by the
sterilized load.
f) dimensions of the usable space and the loading capacity of the sterilizer;
g) the mean and peak sound power levels generated by the sterilizer, expressed as an A-
weighted sound power
level;
h) the sound power levels for any additional device, delivered with the sterilizer but separate
from it, and which is
necessary for its operation;
i) details of the pre-programmed operating cycle(s) and their application;
j) declaration of compliance with the EMC requirements in 4.2.4.2;
k) notification that national legislation about limitations on formaldehyde concentration in air at
the working place
may exist (see also F.3);
l) any restriction for installation or operation (e. g. due to EMC properties);
m) further details of equipment installation for safety as required by EN 61010–2–042:1997,
5.4.3;
n) instructions for disposal of the sterilizer packaging.
6.2 Before installation qualification at least the following information shall be provided:
a) user instructions including at least:
1) general description of the field of application with available sterilization cycles, including
values and
tolerances for the process parameters for which efficacy and safety has been established .
2) details of pre-heating time of the sterilizer chamber required to obtain operational condition
of the
sterilizer;
3) characteristics of consumables and accessories dedicated to the sterilizer;
NOTE 1 This may include instructions for disposal.
4) dimensions of the sterilizer chamber;
5) description of controls as well as indicating, operating and recording devices;
6) instructions for the actions to be taken in case of malfunctions;
7) instructions for daily/regular cleaning and other maintenance if required;
8) details of tests to be used at normal operation of the sterilizer and the frequency at which
they should
be carried out;
NOTE 2 Determination of frequency and extent of validation, routine control and requalification of the
sterilization ability is
not a part of the sterilizer documentation. National guidance may exist on this topic.
9) brief description of safety devices;
10) further details of equipment operation for safety as required by EN 61010–2–042:1997,
5.4.4;
11) instructions for loading;
b) brief operating instructions;
c) maintenance manual including at least:
1) maintenance including maintenance intervals;
2) safety device checks and settings;
3) wiring and piping diagrams;
4) guidance for service and spare parts.
NOTE 3 Regular maintenance is essential to preserve the performance and safety of the sterilizer as
well as to ensure
continuous low formaldehyde emissions.
d) manufacturer's declaration on conformity with this standard;
e) details of required data and qualities of services and sterilant (see 9.1 c));
f) the location of the reference measuring point;
g) reference to annex E and annex D of this Standard for informative data regarding
limitations of formaldehyde
residues on medical devices and methods for their determination respectively;
h) cleaning instructions for the chamber and the exterior including the type of agents to be
used;
i) further details of equipment maintenance for safety as required by EN 61010–2–042:1997,
5.4.5;
j) instructions for disposal of the sterilizer.
6.3 An attachment for documents intended for routine use shall be provided.
6.4 The brief operating instructions shall be provided with a protective cover suitable for
posting if this
information is not permanently and legibly fixed on the sterilizer. (See 9.2 b)).
6.5 To avoid safety-related characteristics and declared CE-conformity being jeopardized,
accompanying
documents shall notify that maintenance or modifications of the sterilizer shall be carried out
by persons authorized
by the party that has placed it on the market. If approvals for spare parts, consumables and
accessories are
essential for the safety or function of the sterilizer, this shall be additionally stated.
7 Service and local environment
7.1 General
The user shall be informed about requirements for installation site services that are not a part
of the sterilizer (see
9.1 b).
NOTE The performance of a sterilizer is dependent upon its design and construction together with the
quality of services
provided.
Sterilizers complying with this standard shall operate with services meeting the following
requirements.
7.2 Electricity
Electrical supply system, configuration, voltage and connected power shall comply with the
specifications provided
for the sterilizer. A stationary connection shall be provided (see 6.1 b) and 7.1).
7.3 Sterilant
7.3.1 Vaporizing a microbicidal solution, prepared in a ratio specified for the process, shall
generate the sterilant.
7.3.2 The composition and concentration of the microbicidal solution shall correspond to the
specifications
provided for the process.
7.3.3 The microbicidal solution to be used shall be stabilized (e. g. by methanol) to avoid
polymerization.
7.3.4 The microbicidal solution containers intended for use in the sterilizer shall correspond to
the specifications
provided for the sterilizer.
7.3.5 If the sterilizer requires other supplies than the microbicidal solution, it shall be ensured
that they are noninterchangeable.
7.3.6 Storage requirements and expiry date of the microbicidal solution shall be stated on
containers intended for
use in the sterilizer.
7.4 Steam
7.4.1 Steam generated by a dedicated steam supply or steam from an external supply may be
used.
7.4.2 The quality of steam required for the process shall be according to specifications (see
9.1 b) and 10.1).
NOTE EN 285 may be used as a guidance document.
7.5 Water
7.5.1 Water used for sterilizer operation
The sterilizer shall be designed to operate with water, which is of potable quality and supplied
at a temperature not
exceeding 15 C.
NOTE 1 The temperature of water should be as low as possible because of its effect on the
performance of vacuum
systems. Higher water temperatures may reduce the capacity of the vacuum system.
NOTE 2 The sterilizer should be designed to operate with water of a hardness value between 0,7 mmol/l
and 2,0 mmol/l.
Hardness values outside these limits may cause scaling and corrosion problems.
NOTE 3 For quality of potable water, see Directive 80/778/EEC.
NOTE 4 National regulations may require a backflow protection in the supply line.
7.5.2 Feed water
The requirements for water intended for steam production within the sterilizer or for a
dedicated steam supply shall
be specified (see 9.1 b) and 10.1).
NOTE Such water should be free from contaminants in a concentration that can impair the sterilization
cycle or harm the
sterilizer or sterilized load. EN 285 may be used as a guidance document.
7.6 Compressed air
If compressed air is required, it shall:
be filtered to 25 μm;
free of liquid water and oil droplets greater than 2 μm;
be supplied at a pressure specified for the sterilizer (see 9.1 b) and 10.1).
7.7 Drainage and discharges
Additional requirements for drainage facilities shall be specified (see 9.1 b) and 10.1).
NOTE 1 National regulations normally specify basic design requirements including a backflow
protection.
NOTE 2 EN 61010–2–042 includes additional requirements for drainage and discharges affecting safety
and environmental
aspects (see 9.1 l)).
7.8 Ventilation and environment
The sterilizer shall be designed to operate in a temperature and relative humidity of 35 °C and
85 % respectively.
NOTE This can require the provision of a ventilation system designed and constructed to remove the
heat transmitted from
the sterilizer and from the sterilizer load when unloading.
Installation site ventilation facilities shall be installed as required by safety or environmental
aspects in
EN 61010-2-042:1997 (see 9.1 l) and (10.1).

Sterilizers Autoclave

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Aleppo University

Faculty of electrical & electronic Eng.

Medical Instrument Dep.

In today' s world, the need for

Supervision Dr. Hassan Sharabaty

Heated Chemical Vapor Sterilizers

Glass Bead Sterilizers

Steam Sterilizer ( autoclave )

The benefits of sterile surgery were starting to catch on

The autoclave is not quite as common, with the

 Large Hospital Sterilizers which is similar

An autoclave should ideally be a one-touch

Sterilizer chamber is made of materials which shall not release any

Also the inner sterilizer chamber surface have to be heated to

achieve preset temperature .(see Annex A) Double locking safety device

There are physical, chemical, and biological indicators that

Chemical indicators can be found on medical packaging

 Measurement probe considerations

The rigorous environment of autoclave sterilizer chambers means that temperature

The cable is colour coded to BS EN IEC 584-3.

o When used for control, monitoring or registration purposes, pressure measuring

Timers and time indicating devices

(general, may vary with autoclave and application)

 Number of loads per day.

Options and accessories

 Glassware, instruments & apparatus

The HTM2010 compliance package includes the following:

 self-monitoring (TACTROL® control system continuously monitors itself for

Automatic Series Features:

 pre-set sterilization programs

 Tuttnauer Semi-Automatic Autoclaves last longer

A new technique in locking doors …

Ozone was discovered in 1840 and its water

Despite widespread recognition of the powerful

Terms and definitions

Spores of a heat-resistant bacterium

Solenoid a coil of wire around an iron core

Figure 1 — Arrangements for temperature and pressure sensors

1.3.4 Pressure measuring and indicating devices

Figure 2 Example of a LTSF sterilization process

Key a Sterilization process

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