The validation and

periodic testing of
benchtop vacuum
steam sterilizers

BULLETIN
MDA DB 9804
JUNE 1998
The Medical Devices Agency helps safeguard public health by working with users, manufacturers and
lawmakers to ensure that medical devices meet appropriate standards of safety, quality and performance
and that they comply with the relevant Directives of the European Union.

Our primary responsibility is to ensure that medical devices achieve their fullest potential to help
healthcare professionals give patients and other users the high standard of care they have a right to
expect.

The Medical Devices Agency is an Executive Agency of the Department of Health

WHO THIS DOCUMENT IS FOR
This bulletin does not specify requirements but is intended to provide
guidance to owners, managers and Users of vacuum benchtop steam
sterilizers, and to those responsible for installation, validation and routine
testing of these devices.

For Owners and Managers: this document draws attention to obligations

under Consumer Protection, and Health and Safety legislation, in order to
minimise risk to patients and operators.
This includes ensuring that:

l
the equipment complies with safety requirements and it is
installed and maintained appropriately;

l it is operated in accordance with the manufacturers

instructions;

l
operators are trained;

l it is validated and routinely tested;

l records of validation, performance qualification, periodic

testing, and sterilization cycles are made, and retained under
appropriate conditions.

For Users: this document provides information to ensure the sterilizer is

functioning safely and correctly through:

l
daily testing;

l weekly safety checks and

l weekly testing.

For medical physicists and Test Persons (sterilizers): this document

provides test protocols. Methods of test are provided in Annex A.

This bulletin complements the Medical Devices Agency’s (MDA)'s

2
Device Bulletin DB9605 , ‘The purchase, operation and maintenance of
benchtop steam sterilizers’.
SUMMARY
Saturated steam under pressure at the highest temperature compatible with
the product is the preferred method for the sterilization of medical devices.

Steam sterilization requires direct contact between dry saturated steam and
all surfaces of the load at a specified temperature and pressure, and for a
specified time. Direct contact is prevented by blood, mucus and tissue
deposits on the load items, and by air present in the chamber and load. To
enable sterilizing conditions to be achieved, load items must, therefore, be
cleaned thoroughly and air removed effectively from the chamber and
load. Guidance on cleaning and decontamination of medical devices is
provided in MDA’s publication ‘Sterilization, disinfection and cleaning of
3
medical equipment’ .

Sterilization is a process whose effectiveness cannot be verified by

inspection and testing of the product. For this reason, successful
sterilization depends on the consistent reproducibility of sterilizing
conditions. Sterilizers have therefore to be validated before use, their
performance monitored routinely (by periodic testing) and the equipment
properly maintained.

Whenever practicable, sterile items should be obtained from a central

Sterile Services Department which has the equipment and expertise to
decontaminate and sterilize re-usable medical devices; they also offer
consistent quality and economy of scale. In the absence of central
sterilization services a suitable, properly operated, benchtop steam
sterilizer may be used provided it has been validated for the intended load.

This Bulletin provides guidance on the validation and periodic testing of

vacuum benchtop steam sterilizers whose chamber volume is less than 54
litres. These sterilizers are equipped with a pre-sterilization active air
removal (vacuum) stage and are not connected permanently to main
services. They may also be referred to as benchtop porous load
sterilizers. For sterilizers which are permanently connected to main
services, reference should be made to Health Technical Memorandum
2010 (HTM 2010) - Sterilization, Part 3: Validation and verification’.

Steam sterilizers have to be validated to demonstrate that the physical

conditions required for sterilization (temperature, pressure and time) are
achieved. This includes commissioning checks and tests (to ensure that the
equipment, as delivered, functions safely and will produce sterilizing
conditions consistently), and routine periodic testing to ensure that the
equipment continues to perform correctly.
It is the responsibility of the manager of the sterilizer to ensure that the
sterilizer is functioning correctly, is safe to use and will produce sterile
product consistently. The manager is therefore ultimately responsible for
agreeing the necessary validation and periodic testing and may wish to
seek independent advice from a person who is knowledgeable and
experienced in all aspects of sterilization, such as an Authorised Person
(sterilizers).
1
The test methods for steam sterilizers are provided in HTM 2010 : Part 3
and wherever possible we specify test methods by reference to HTM 2010.

Daily tests have to be performed by the User and because Users may not
1
have access to HTM 2010 , the test methods for these are provided in full.

For some of the periodic tests which are performed by a Test Person
(sterilizers) [TP(s)], the HTM 2010 method is not directly applicable. In
these cases methods are either provided by the sterilizer manufacturer, or
in this bulletin. The User may wish to have any manufacturer’s
recommendations or test methods verified during commissioning.
The validation and periodic testing of
benchtop vacuum steam sterilizers

CONTENTS
1. GLOSSARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.1 Personnel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.2 Testing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2. INTRODUCTION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3. PRESSURE SYSTEMS AND TRANSPORTABLE GAS
CONTAINERS REGULATIONS 1989. . . . . . . . . . . . . . . . 8
4. ASSURING THE PERFORMANCE OF STERILIZERS . . . 8
4.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
4.2 Test equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
4.3 Documentation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
4.4 Procedure on failure of a test . . . . . . . . . . . . . . . . . . . . . 11
4.5 THE VALIDATION PROCESS . . . . . . . . . . . . . . . . . 11
4.6 COMMISSIONING. . . . . . . . . . . . . . . . . . . . . . . . . . 11
4.6.1 Installation checks and tests . . . . . . . . . . . . . . . . . . . 12
4.6.2 Installation tests . . . . . . . . . . . . . . . . . . . . . . . . . . 12
4.6.3 Preliminary checks . . . . . . . . . . . . . . . . . . . . . . . . . 12
4.6.4 Electrical checks. . . . . . . . . . . . . . . . . . . . . . . . . . 12
4.6.5 Functional checks. . . . . . . . . . . . . . . . . . . . . . . . . 13
4.6.6 Response to faults . . . . . . . . . . . . . . . . . . . . . . . . . 14
4.6.7 Installation tests . . . . . . . . . . . . . . . . . . . . . . . . . . 14
4.6.8 Commissioning tests. . . . . . . . . . . . . . . . . . . . . . . 15
4.7 PERFORMANCE QUALIFICATION. . . . . . . . . . . . . . . . 17
5. PERIODICTESTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
5.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
5.2 Weekly and quarterly safety checks . . . . . . . . . . . . . . . 18
5.3 Yearly safety checks . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
5.4 Yearly tests and revalidation . . . . . . . . . . . . . . . . . . . . 21
6. USE OF CHEMICAL INDICATORS. . . . . . . . . . . . . . . . . 23
ANNEX A - Test methods. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
A.1 Steam penetration test. . . . . . . . . . . . . . . . . . . . . . . . . . 24
A.2 Automatic control test. . . . . . . . . . . . . . . . . . . . . . . . . 25
A.3 Air leakage test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
A.3.1 Automatic test - User. . . . . . . . . . . . . . . . . . . . . . . . 28
A.3.2 Manual test - Test Person. . . . . . . . . . . . . . . . . . . . . 28
A.4 Chamber wall temperature test . . . . . . . . . . . . . . . . . . . 28

A.5 Thermometric tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

A.5.1 Small load test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
A.5.2 Full load test . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
A.5.3 Solid load test. . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

1
 A.6 Load dryness tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
A.6.1 Porous load . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
A.6.2 Solidload . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
A.7 Microbiological test for Performance Qualification . . . . 32
A.8 Standard test pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
ANNEX B - European directive . . . . . . . . . . . . . . . . . . . . . . . . . 33
ANNEX C - Pressure systems and transportable gas containers
regulations 1989 . . . . . . . . . . . . . . . . . . . . . . . . . . 35
ANNEX D - Sources of further information . . . . . . . . . . . . . . . . 36
ANNEX E - MDA publications relevant to sterilization . . . . . . . . 37
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

2
1 GLOSSARY
1.1 Personnel

Further information, including qualifications and areas of responsibility,

4
can be found in HTM 2010 : Part 1 .

Is a person designated by management to provide independent auditing and

advice on sterilizers and sterilization and to review and witness validation
documentation. A list of suitably qualified Authorised Persons (Sterilizers)
is maintained by the Institution of Healthcare Engineering and Estates
Management (see Annex D).

Is a person or organisation designated by management to exercise certain

legal responsibilities under the Pressure Systems and Transportable Gas
4
Containers Regulations 1989 (see HTM2010 : Part1 ).

Is a person or organisation designated by management to be responsible for

the supply and installation of the sterilizer, and for the conduct of the
installation checks and tests. The contractor is commonly the manufacturer
of the sterilizer.

Is the person who is ultimately accountable for the operation of the

premises. Depending on the nature of the organisation, this may be the
owner, occupier, employer, general manager, chief executive, or other
person of similar authority. In small, autonomous installations the User
may take on this function.

Is a person or organisation responsible for the manufacture of a sterilizer

or other equipment.

Is any person with the authority to operate a sterilizer, including the noting
of sterilizer instrument readings and simple housekeeping duties.

Is a person designated by management to carry out validation and periodic

testing of sterilizers.

Is a person designated by management to carry out maintenance duties on

sterilizers.

Is the person designated by management to be responsible for the

management of the sterilizer. In a hospital the User could be a Sterile
Services Department manager or Theatre manager or, in primary care, a
general practitioner, dentist, or other healthcare professional.

3
 1.2 Testing:
is the removal of air from the chamber using mechanical means eg vacuum
pump.

are the physical characters, such as time, temperature, pressure, that

influence the efficacy of the sterilization process.

is the period which elapses between attainment of the sterilization

temperature in the chamber and the attainment of the sterilization
temperature at all points within the load. It begins when the temperature in
the coolest part of the chamber (normally the active chamber discharge)
first attains the sterilization temperature. It ends when the holding time
begins.

begins when the part of the load that is the slowest to heat up first attains
the sterilization temperature. It ends when the temperature in the coolest
part of chamber falls below the sterilization temperature.

a device which is open at one end, is hollow if the ratio of cavity length to
diameter is greater than one. If the device is double open-ended, it is
hollow if the ratio of cavity length to diameter is greater than two.

is that shown by a visual display fitted permanently to the sterilizer,

is that shown on a test instrument, such as a thermometric recorder or a test

pressure gauge, attached to the sterilizer for test purposes.

air and other gas which will not condense under the conditions of steam
sterilization.

is that written down by the operator, usually as the result of observing an

indicated. recorded or measured value.

is the process of obtaining and documenting evidence that the equipment

as commissioned will produce acceptable product when operated in
accordance with the process specification.

is the equilibration time plus the holding time.

material or configuration that can hold or trap air that will interfere with
steam penetration.

4
is that shown on the output of a recording instrument fitted permanently to
the sterilizer.

are the ranges of the cycle variables which may prevail throughout the
chamber and load during the holding time.

is the minimum acceptable temperature of the sterilization band.

is the range of temperatures which may prevail throughout the load during
the holding time. These temperatures are expressed as a minimum
acceptable temperature (the sterilization temperature) and a maximum
allowable temperature, and are stated to the nearest degree Celsius.

2 INTRODUCTION
Minor surgical procedures are increasingly being performed in healthcare
premises and General Practitioners’ (GPs’) surgeries; they are performed
regularly in dental practices.

Whenever practicable the sterile items required for these procedures should
be obtained from a central Sterile Services Department (SSD). These have
the equipment and expertise to decontaminate and sterilize re-usable
medical devices; they also offer consistent quality and economy of scale.
In the absence of central sterilization services a suitable validated, and
properly operated, benchtop steam sterilizer may be used.

Benchtop steam sterilizers in which air is passively displaced by steam are

suitable only for processing instruments and utensils that are not wrapped,
and are not hollow. Instruments or utensils enclosed in any form of
wrapping, hollow items or devices with lumens, and porous materials
should be processed only in a benchtop sterilizer equipped with an active
air removal system which has been validated for the intended loads.

Steam sterilization requires direct contact between dry saturated steam and
all surfaces of the load at a specified temperature and pressure, and for a
specified time. Direct contact is prevented by blood, mucus and tissue
deposits on the load items, and by air present in the chamber and load. To
enable sterilizing conditions to be achieved, load items must, therefore, be
cleaned thoroughly and air removed effectively from the chamber and load.
Effective air removal is essential to enable steam to penetrate packs and
lumens, and this can only be achieved if the sterilizer is equipped with an
active air removal system. Such sterilizers are known as vacuum benchtop
sterilizers or benchtop porous load sterilizers.

5
 Vacuum benchtop sterilizers are available from a number of manufacturers
and are essential when the load includes:

l
hollow instruments and utensils, either wrapped or
unwrapped;

l
wrapped solid instruments and utensils;

l
porous loads.

They have the following features:

l
an active air removal stage prior to the sterilizing stage;

l
a post-sterilization drying stage;

l
electrical heating;

l
sterilizing chamber volume less than 54 litres;

l
no connections to main services (except for electricity).
(Note : Benchtop steam sterilizers which are connected to
main services should meet in full the testing
1
requirements of HTM 2010: Part 3 .)

The active air removal (vacuum) stage is essential if sterilizing conditions

are to be established and maintained throughout the load for one of the
temperature/time combinations specified in Table 7 (p.27).

The drying stage is intended to reduce the moisture content of packages

and porous materials to a level which will not permit bacterial
recontamination.

Sterilization is a process whose effectiveness cannot be verified by

inspection and testing of the product. For this reason, successful
sterilization depends on the consistent reproducibility of sterilizing
conditions. Sterilizers have therefore to be validated before use, their
performance monitored routinely (by periodic testing) and the equipment
properly maintained.

Validation is intended to demonstrate that the physical conditions required

for sterilization (temperature, pressure and time) are achieved. It includes
commissioning checks and tests (to ensure that the equipment, as
delivered, functions safely and will produce sterilizing conditions
consistently), and routine periodic testing to ensure that the equipment
continues to perform correctly.

6
Guidance on the management, installation, validation, periodic testing,
operation and maintenance of a variety of types of sterilizer is provided in
Health Technical Memorandum (HTM) 2010. This is published in six Parts
1
and Part 3 is the standard work on the validation and periodic testing of
sterilizers, but it only partly covers vacuum benchtop sterilizers.
2
The Medical Devices Agency (MDA) Device Bulletin DB9605 , published
in June 1996, provides information specific to benchtop steam sterilizers
for unwrapped solid instruments and utensils but is not directly applicable
to vacuum benchtop steam sterilizers.

This bulletin provides guidance to Users, Test Persons (sterilizers)

[TP(s)] and Authorised Persons (sterilizers) [AP(s)] on the validation
and periodic testing of vacuum benchtop steam sterilizers which are
not fully covered in other publications.

These terms are explained in the Glossary.

A list of suitably qualified AP(s) is maintained by the Institute of

Healthcare Engineering and Estate Management (see Annex D). The AP(s)
will provide advice regarding the services of a TP(s), where necessary.

Users are reminded of their obligations under the Consumer Protection and
Health and Safety legislation.

Amongst other things, Users must ensure that the equipment complies with
safety requirements, it is installed and maintained appropriately and that it
is validated and routinely tested. The equipment should be operated only in
accordance with the manufacturer’s instructions. Operators who are
familiar with other types of steam sterilizer are not necessarily qualified to
operate vacuum benchtop steam sterilizers unless they have received
specific training in the use of this equipment.

Because vacuum benchtop steam sterilizers are more complicated than the
traditional (non vacuum) benchtop steam sterilizers, they require more
rigorous testing to demonstrate that they function correctly.

It is MDA’s opinion that this type of sterilizer should be equipped only

with cycles for porous loads in order to minimise the possibility of an
incorrect cycle being selected and consequentfailure to sterilize the load.

7
 3 PRESSURE SYSTEMS AND
TRANSPORTABLE GAS
CONTAINERS REGULATIONS 1989
Benchtop steam sterilizers contain pressure vessels and must comply with
the Pressure Systems and Transportable Gas Containers Regulations 1989
5
(SI 1989/2169) . These regulations are intended to minimise the risk of a
pressure system, or part of it, failing and causing injury. They require all
persons using these machines to be adequately trained in their operation
and in the procedures to be used in an emergency.

Owners are primarily responsible for ensuring compliance.

All pressure vessels must be inspected periodically by a Competent Person

(Pressure Vessels), according to a written scheme. Further information is
provided in Annex C.

4 ASSURING THE PERFORMANCE OF

STERILIZERS

4.1 Introduction
The effectiveness of sterilization cannot be verified retrospectively by
inspecting or testing the product. Tests and checks carried out during
manufacture, during validation and during periodic testing of the sterilizer
provide assurance that the process will consistently produce a sterile product.

Standards and Regulations

6
Under the Medical Devices Directive (93/42/EEC) , sterilizers which are
intended to re-process medical devices will have to be manufactured to meet
acceptable standards of safety and performance. All such sterilizers placed
on the market after 13 June 1998 will have to bear the CE marking,
signifying conformity with this Directive. [See Annex B for more
information]. Until 14 June 1998, in the absence of CE marking, sterilizers
should be manufactured under a recognised quality management system eg
7 8
BS EN ISO 9001 (1994) or BS EN ISO 9002 (1994) and should comply
9 10 11
with BS3970 : Part 1 : 1990 , BS EN 61010 : Parts 1 and 2-041 and the
Electro Magnetic Compatibility (Amendment) Regulations 1994 (SI 1994
12
No 3080) . Most steam sterilizers will have to conform with the Pressure
Equipment Directive when it comes into force (see Annex B).

At present there are no standards which apply specifically to vacuum

13,14,15
benchtop sterilizers, but European Standards are being prepared (1998)
under a mandate from the European Commission.

8
Steam sterilizers have to be validated to demonstrate that the physical
conditions required for sterilization (temperature, pressure and time) are
achieved. This includes commissioning checks and tests (to ensure that the
equipment, as delivered, functions safely and will produce sterilizing
conditions consistently), and routine periodic testing to ensure that the
equipment continues to perform correctly.

Validation
Specified checks and tests should be carried out following delivery and
installation of the sterilizer (and at regular intervals thereafter) to provide
assurance that a sterilizer is safe to use and will consistently achieve
sterilizing conditions throughout a load.

Periodic Testing
The User is required to perform routine daily tests. After suitable training,
and with the agreement of the AP(s), the User may also carry out weekly
testing. These tests, and the reference to the test procedure, are presented
in tables 1 to 4. Details of the test methods are in Annex A. Some of the
more complicated tests undertaken by the TP(s) are specific to vacuum
benchtop steam sterilizers and test methods for these are also provided in
Annex A. Other tests performed by the TP(s) are identical to those in HTM
1
2010 : Part 3 and are identified in the Tables by reference to the relevant
paragraphs in the HTM.

Maintenance
Appropriate maintenance is essential to ensure the continuing safety and
performance of the sterilizer. The User may perform minor, routine
maintenance tasks specified by the manufacturer but other maintenance or
repair should be performed only by trained specialists. Before a sterilizer
is returned to service after modification or repair it should be tested and
checked to provide assurance of the effectiveness of the sterilization
process and the safety of the equipment.

Where repairs or modifications have involved any part of the pressure

system (eg the pipework, the chamber, and its fitting) the advice of a
5
Competent Person (pressure vessels) should be sought before the sterilizer
is returned to service.

4.2 Test Equipment

Information about the type of test equipment required for the validation
and routine testing of steam sterilizers, its calibration and sources of error
1
is available in HTM 2010 : Part 3, Chapter 6 .

Tests performed by the User should not require specialised test equipment.

9
 4.3 Documentation

Guidance on the documentation that should be kept is provided in HTM

16
2010 : Part 4 .

Records of maintenance, testing and operating cycles provide evidence that

the process will deliver sterile product consistently. All checks, tests and
maintenance performed on sterilizers must be documented and the records
7
kept securely as specified in BS EN ISO 9001 (1994) or BS EN ISO 9002
8
(1994) ,and the Pressure Systems and Transportable Gas Containers
5
Regulations 1989

A record should be made of the values and permitted tolerances of the

cycle variables for each correctly functioning operating cycle available to
the operator, and for each load type that is to be processed. This forms the
Master Process Record (MPR) against which:

l the User should compare production cycle records to verify

that sterilizing conditions have been achieved for each load;

l the results of the weekly User tests should be compared to

establish whether the sterilizer is functioning correctly and
achieving sterilizing conditions.

The MPR also provides the means to determine whether the results of
periodic tests and performance re-qualification tests carried out by the
TP(s) are satisfactory. Information about the preparation of an MPR is
1
provided in HTM2010: part 3 , 8.58 et seq.

The results of the daily tests should be recorded in the sterilizer log book,
dated and signed by the User. Steam penetration indicator test sheets,
marked with the result of the test, dated and signed by the operator, should
be retained for at least three months and stored under the conditions
recommended by the manufacturer of the test sheet.

Every production cycle must be fully documented and the record kept
securely for the time specified by the management [guidance is provided in
17
Health Circular HC(89)20 ]. The information recorded should include:

l whether the cycle was a pass or a fail;

l the date and cycle number;
l the chart record for the cycle;
l the identity of the operator;
l the type of load (eg whether porous materials, solid
instruments, hollow instruments or a mixture etc);

10
 l
the sterilization cycle selected.
Recording and retention of temperature, pressure and time data generated
during testing and normal use of the sterilizer is simplified if the sterilizer
is fitted with a recorder.

[It is MDA’s opinion that this type of sterilizer should always be equipped
with a pressure and temperature recorder.]

4.4 PROCEDURE ON FAILURE OF A TEST

The AP(s) and the User should agree in advance the procedure for handling
test failures.

A failure of a test implies that the sterilizer is not working to specification

and it should be withdrawn from service, the failure investigated, and the
cause rectified.

It should be emphasised that the User has the ultimate responsibility

for certifying that the sterilizer is fit for use.

4.5 THE VALIDATION PROCESS

Validation is the documented procedure for obtaining, recording and

interpreting the results needed to show that a process will consistently yield
a product complying with pre-determined specifications. It is considered as
a total process which comprises commissioning followed by performance
qualification (Figure 1).

Commissioning

VALIDATION
Thermometric tests
Performance qualification (PQ)
Microbiological tests
(if necessary)
Figure 1. The validation process

4.6 COMMISSIONING

Commissioning is the process of obtaining and documenting evidence that

the equipment has been supplied and installed in accordance with its
specifications, that it is safe to operate and that it functions within pre-
determined limits when operated in accordance with the manufacturer’s
operating instruction. It consists of installation checks, installation tests
and commissioning tests which should be carried out after installation of
the sterilizer in the place of use.

During commissioning, t h e A P ( s ) m a y w i s h t o v e r i f y a n y
recommendations from the manufacturer relating to test procedures.
11
 4.6.1 Installation checks and tests

The purchasing contract should specify who is responsible for carrying out
installation checks and tests.

4.6.2 Installation checks - the Contractor

These are set out below and are carried out by the contractor (who may also
be the manufacturer), after the sterilizer has been delivered and installed.

4.6.3 Preliminary checks

Check that:

l
the sterilizer has been supplied and installed in accordance
with the contract;

l
no defects are apparent from a visual inspection of the
sterilizer;

l
security and settings of door safety switches and door-
locking components comply with data provided by the
18
manufacturer and with HSE Guidance Note PM73 ;

l
load supports, trays and other aids are effective and safe in
use;

l
keys, codes or tools required to operate locked cycle-select
controls are supplied and operate satisfactorily and that each
key, code or tool unlocks only the cycle-select control for
which it is intended;

[To prevent an inappropriate cycle being selected by the

operator, controls which enable non-standard cycles to
be selected should be available only to Maintenance
Persons (sterilizers), TP(s) and AP(s).]

l
the manufacturer has supplied all the documents specified in
the contract, including calibration verification certificates for
the temperature and pressure instruments and controllers.

4.6.4 Electrical checks

After 13 June 1998 benchtop steam sterilizers intended to reprocess medical

devices will have to bear the CE marking, signifying that the equipment
meets relevant standards of safety and performance (including electrical
6
safety) of the Medical Devices Directive 93/42 EEC . Until then, the

12
 10
sterilizer should conform with the requirements of BS EN 61010 : Part 1 ,
11
and Part 2 - 041 and a certificate of conformity should be provided. The
19
electrical installation in the building should conform with BS 7671 . No
further electrical tests are necessary provided that a visual inspection
confirms that the equipment and electrical installation is undamaged.

4.6.5 Functional checks

Several cycles may be necessary to complete all the functional checks.

During an operating cycle with an empty chamber, the following shall be

checked:

l
the selection of automatic or manual control is by key, code
or tool. [Manual control should be available only to
Maintenance Persons (sterilizers), TP(s) and AP(s) for
testing];

l
the operating cycle cannot start until the door is closed and
locked;

l
throughout the cycle, indicated and recorded steam pressures
and temperatures are within the limits specified by the
manufacturer, and the sterilization temperature and hold
time are within the appropriate band specified in Table 7,
p27;

l
there are no leaks of steam or water;

l
the operation and readings of all instruments appear
satisfactory;

l
where the air vent and/or the chamber drain discharges into
the water reservoir, that the water in the reservoir does not
boil.

At the end of a cycle check that:

l
the door opening system cannot be operated until the
chamber pressure has returned to atmospheric pressure;

l
the door interlock system is fitted with at least two
independent interlocks and failure of one interlock does not
allow the door to be opened when conditions within the
chamber would cause a hazard;

l
the automatic controller has operated in accordance with the
specification.

13
 4.6.6 Response to faults

The sterilizer should not create a safety risk and should not give a false
indication of “cycle complete” when it is subjected to the following
simulated faults :

l
interruption of power supply (including power failure,
operation of emergency stop button - where fitted, switching
off, etc);

l
insufficient water to complete a cycle;

l
the required vacuum level, before or after the sterilization
stage, is not achieved;

l
the required combination of sterilizing temperature and hold
time is not achieved;

l
excessive pressure and/or temperature in the chamber for the
cycle selected.

When excessive pressure has been generated in the chamber it is advisable,

before the sterilizer is re-pressurised, for a Competent Person (pressure
vessels) to check that the pressure integrity of the chamber has not been
impaired and that the over-pressure protection devices function correctly.

If the sterilizer fails any check, the condition causing the failure must be
rectified and the complete programme of checks repeated sequentially.

After successful completion of all checks, the contractor shall carry out the
installation tests to demonstrate that the sterilizer is working satisfactorily
and that it complies with its specifications.

4.6.7 Installation tests - the Contractor

These tests should be carried out by the contractor, after successful

completion of the safety checks, using the method prescribed in this
document. They should be carried out with the sterilizer at normal working
temperature (except for the air leakage test) and completed in the order
shown in Table 1.

14
 TABLE 1
INSTALLATION TESTS
These tests should be performed by the contractor after successful
completion of the safety checks.
1 Air leakage test* (manual) A.3.2†
2 Automatic control test for each cycle available to the User A.2

3 Verification of calibration of sterilizer instruments (can be HTM 2010:3, 6.32

done at the same time as the previous test). et seq and 12.2

* HTM 2010 refers to this test as Vacuum Leak Test. See annex A, p24.

The Contractor shall provide:

l a list identifying the checks and tests that have been

performed during installation;

l
data showing the control settings (including time,
temperature, pressure and air detection system settings,
where applicable) for each cycle available. For micro-
processor controlled sterilizers, it should be possible to print
out these settings;

l written confirmation that control settings have been set up as

recommended by the manufacturer.

4.6.8 Commissioning tests - the Test Person

Commissioning tests evaluate basic performance and safety. The tests set
out in Table 2 should be performed by the TP(s) after successful
completion of the installation checks and tests; all cycles available to the
User should be tested. The sterilizer should be accepted only after
successful completion of all tests to demonstrate that it is working
satisfactorily and that it conforms with its specifications.

Because the design of these sterilizers may differ considerably between

manufacturers, some of the specified tests may require test procedures
which are unique to particular models of sterilizers. Such cases are
identified in the Tables by the symbol u and for these the manufacturer of
the sterilizer will have to provide the test method.

The manufacturer shall also provide :

l evidence that the water recommended for use in the sterilizer

will consistently produce steam with a non-condensable gas
level below 0.5% when tested by the method described in
15
prEN 13060 - Part 4 ;

15
 l evidence of the effectiveness of the air detection system;

l
evidence of the effectiveness of the sterilizer in processing
the porous loads intended by the manufacturer.

If commissioning follows within 10 working days of the installation tests

there is no need to repeat any commissioning tests which have already been
performed successfully as installation tests.

TABLE 2
COMMISSIONING TESTS
These tests are performed by the TP(s)

Air leakage test (automatic) A.3.1

2 Air leakage test (manual) (temperature and pressure A.3.2
sensors connected)
3 Automatic control test A.2
4 Verification of calibration of sterilizer instruments.* HTM 2010:3, 6.32
et seq and 12.2
5 Chamber wall temperature test** A.4
6 Steam generator overheat cutout test HTM 2010:3, 15.3
7 Air detection system performance test for a small load. u
8 Air detection system performance test for a full load u
9 Thermometric test for a full load A.5.2
10 Load dryness test* A.6.1
11 Thermometric test for a small load A.5.1
12 Thermometric test for a solid load A.5.3
13 Solid load dryness test* A.6.2
14 Thermometric tests for PQ as required by the User HTM 2010:3, 8.13
15 Microbiological tests for PQ A.7
16 Air leakage test (automatic) (sensors removed) A.3.1
17 Air detection system function test (automatic) u
18 Steam penetration test A.1

* Can be done at the same time as the previous test.

u Test method as specified by the manufacturer.
** This test is required only when the chamber wall is heated eg for the
drying cycle.

NOTE : only cycles available to the User need be tested.

16
4.7 PERFORMANCE QUALIFICATION (PQ) - the Test
Person

Data from the thermometric commissioning tests provide assurance that

sterilizing conditions are attained throughout most loads. PQ testing is
needed to show that sterilizing conditions are attained throughout any other
loading condition which the User judges to be particularly difficult to
sterilize.

PQ comprises tests 14, 15, 16, 17, 18 and 10 from Table 2, which are
performed either on the load which the User judges to be particularly
difficult to sterilize or on a test load that represents it.

For some loads, eg lengths of polymeric (including rubber) tubing or other

devices with lumens, thermometric monitoring of the adequacy of air
removal may not be appropriate as residual static air in the tubing may be
heated by conduction. For this type of load, the advice of an AP(s) and a
suitably qualified microbiologist should be sought.

Performance qualification should not be attempted on any sterilizer

that fails to meet the requirements of the commissioning tests.

5 PERIODIC TESTS
5.1 Introduction
The responsibility for performing the Periodic Tests is shared by the User
and the TP(s); the tests are carried out at daily, weekly, quarterly and yearly
intervals to demonstrate that the performance of the sterilizer continues to
be satisfactory. All periodic tests should be carried out with the sterilizer at
normal working temperature (except for the air leakage test) and completed
in the order shown in Tables 3 to 6.

The User should perform the daily tests and, after suitable training, with
the agreement of the AP(s) the User may also perform the weekly tests. The
TP(s) should perform the quarterly and annual tests listed in Tables 5 and
6, for each cycle available to the User.

Air Detectors
Effective removal of air and other non-condensable gas (referred to
collectively as ncg) is essential to the achievement of sterilizing conditions.
Porous load sterilizers must therefore be fitted with a means to detect ncg
present in sufficient quantity to prevent the attainment of sterilizing
conditions within the load. These devices are commonly called air
detectors. They are fitted to large porous load sterilizers. Vacuum Benchtop
steam sterilizers must also be equipped with either an air detector or
another system for detecting the presence of ncg which is capable of being
validated.

17
 Air detector testing
The continued correct functioning of the air detection system must be
tested weekly, quarterly and annually. If the sterilizer is fitted with an air
detector, the method specified for the air detector function test in HTM
1
2010: Part 3 11.62 et seq should be followed. (Note: it may not be possible
to place the pack at the height specified in 11.62). The test should be
performed by a TP(s) but, if the sterilizer is equipped with an automatic test
cycle, the User may perform the weekly test with the agreement of the
AP(s).

As there is unlikely to be a standard air detection system, each sterilizer

manufacturer must specify the test method to demonstrate that the
automatic air detection system is functioning correctly. Although the test
methods may differ, in all cases the test result shall demonstrate that the air
detection system will detect ncg present in sufficient quantity to depress
the temperature at the centre of a test pack by more than 2°C below the
temperature in the active chamber discharge. The test pack shall represent
the maximum density of porous load material that the sterilizer is capable
of processing.

Air detector system performance tests and function tests must also be
performed quarterly and annually by the TP(s) using independent,
calibrated instruments. The results of these tests shall demonstrate the
correct functioning of any automatic air detection system fitted to the
sterilizer.

TABLE 3
DAILY TESTS
These tests may be performed by the User
1 Steam penetration test A.1
2 Automatic control test* A.2

*May be done at same time as the preceding test. This test is not required
if the sterilizer is equipped with a recorder which provides a permanent
record of the temperature, pressure and elapsed time during all sterilizing
cycles.

NOTE : the manufacturer should advise whether these daily tests may
be done without pre-heating the sterilizer chamber.

5.2 Weekly and quarterly safety checks

These checks should be made by the User before starting the sequence of
weekly tests, and by the TP(s) before starting the sequence of quarterly
tests:

18
 l examine the door seal [performed weekly by the User,
quarterly by the TP(s)];

l check the security and performance of door safety devices

[quarterly by the TP(s)];

l make any other checks required by the Competent Person

(Pressure Vessels) (see Annex C) in connection with the
written scheme of examination for the pressure vessel.

TABLE 4
WEEKLY TESTS
These tests should be performed by the test person - after successful
completion of the weekly safety checks .

1 Air leakage test (automatic) A.3.1

2 Automatic air detection system function test u

3 Automatic control test A.2

4 Steam penetration test* A.1

* May be done at the same time as the previous test.

u Test method specified by the manufacturer.

NOTE : these tests may be performed by the User with the agreement
of the AP(s).

19
 TABLE 5
QUARTERLY TESTS
These tests should be performed by the TP(s) - after successful
completion of the weekly safety checks.

1 Air leakage test - automatic A.3.1

2 Air leakage test - manual - (temperature and A.3.2

pressure sensors connected)
3 Automatic control test A.2

4 Verification of calibration of sterilizer instruments* HTM 2010:3, 6.32 et

seq and 12.2
5 Thermometric test for a small load* A.5.1

6 Air leakage test (automatic) (sensors removed) A.3.1

7 Air detection system function test (Manual) HTM2010:3,11.601†

8 Air detection system function test (Automatic) u

9 Steam penetration test A.1

* Can be done at the same time as the previous test

u Test method specified by the manufacturer
† (Note : it may not be possible to place the pack at the height
specified in 11.62).

20
5.3 Yearly safety checks

These are performed by the TP(s), to ensure the safe functioning of the
sterilizer. The checks should be selected from the list of commissioning
checks, identifying those which affect safety and also those which may
have changed over the course of time. The AP(s) will advise which checks
need to be included.

If the sterilizer fails any check, the fault should be rectified and all checks
should be completed satisfactorily before starting the yearly or revalidation
tests.

5.4 Yearly tests and revalidation

The yearly and revalidation test programmes are identical and are
performed by the TP(s).

The yearly tests are intended to confirm that the data generated during
validation remain consistent and valid.

Revalidation comprises recommissioning and performance requalification.

It is required:

l when modification or engineering work has been carried out

which could affect the performance of the sterilizer*;

l after planned maintenance, repair or any work requiring the

removal of components that could affect the performance of
the sterilizer*;

l when the preset values of cycle variables have been changed;

l when the software used for the control of the process has
been modified;

l when the batch record is outside the limits specified on the

MPR;

l when the sterilizer is returned to service after investigation

and correction of unacceptable deviations from the Master
Process Record (MPR);

l
when required by the User or the AP(s).

* In these cases it may be necessary for a Competent Person (pressure

5
vessels) to examine the sterilizer before it is tested.

21
 TABLE 6
YEARLY AND REVALIDATION TESTS
These tests are performed by the TP(s) - after the successful completion
of the yearly safety checks.
1 Air leakage test (automatic) A.3.1
2 Air leakage test (manual) (temperature and pressure A.3.2
sensors connected)
3 Automatic control test A.2
4 Verification of calibration of sterilizer instruments* HTM 2010:3, 6.32
et seq and 12.2
5 Chamber wall temperature test** A.4
6 Steam generator overheat cutout test HTM 2010:3, 15.3
7 Air detection system performance test for a small load u
8 Air detection system performance test for a full load u
9 Thermometric test for a full load A.5.2
10 Porous load dryness test* A.6.1
11 Thermometric test for a small load A.5.1
12 Thermometric test for a solid load* A.5.3
13 Solid load dryness test A.6.2
14 Tests for performance requalification as required HTM 2010:3, 8.64
by the User
15 Air leakage test (automatic) (sensors removed) A.3.1
16 Air detector system function test (automatic) u
17 Steam penetration test A.1

* May be done at the same time as the previous test.

u Test method as specified by the manufacturer.
** This test is required only when the chamber wall is heated eg for the
drying cycle.

Revalidation
The revalidation tests are identical to those in the yearly tests schedule set
out above. Any performance qualification tests which were performed
during the original validation will need to be repeated. Note: this is
necessary only for loads that will continue to be processed.

22
6 USE OF CHEMICAL INDICATORS
20
BS EN 867 : 1997 provides specifications for chemical indicators for
sterilization processes.

Chemical indicators should be used only for the process specified by

the manufacturer, as the use of an inappropriate indicator may give
dangerously misleading results.

Chemical indicators are designed to show a defined colour change when

specified conditions have been attained but they should only be used to
supplement definitive thermometric results. A failed operating cycle
must always be regarded as unsatisfactory, irrespective of the results
obtained from any chemical indicators.

The performance of indicators may be adversely affected by the storage

conditions before use, the methods of use, and storage conditions after use.
It is important, therefore, to select the correct indicator and to follow the
manufacturer’s recommended instructions precisely. Indicators should not
be used beyond the expiry date stated by the manufacturer.

There are two types of chemical indicator which are commonly used in
steam sterilizers:

a) process indicators (eg autoclave tape), known as Class A indicators,

which serve only to distinguish processed items from unprocessed
items. These indicators should not be used for any other purpose;

b) indicators for use in specific tests, known as Class B indicators.

These include indicators for use in standard test packs to indicate the
effectiveness of steam penetration (the Bowie and Dick test), and in
disposable/reusable alternative Bowie and Dick type test packs.

The indicators to which this bulletin refers are Class B indicators.

Class D (integrating) indicators are available for monitoring this type of

sterilizer but they do not indicate sterility of the product.

23
 ANNEX A
TEST METHODS

The AP(s) may wish to verify, during commissioning, any

recommendations from the manufacturer relating to test procedures.

A.1 Steam penetration test

This test is analogous to the Bowie and Dick test performed on large
porous load sterilizers and is part of the commissioning, daily, weekly,
quarterly and annual test programmes. The daily and weekly test is
performed by the User or a TP(s); the quarterly and annual test is
performed by a TP(s). The test should be performed according to the
instructions of the sterilizer manufacturer or, if a proprietory test pack is
used, the manufacturer of the test pack.

A successful test confirms that steam penetration into a test pack is rapid
and even and, by implication, that air and other non condensable gas (ncg)
has been effectively removed. It does not confirm that the sterilizing
conditions have been achieved within the load.

The test pack may be either a standard test pack described in A.8 or an
alternative test pack specified by the sterilizer manufacturer (A.8 Note 4).
It contains a Class B chemical indicator which is designed to show a
defined colour change when exposed to a specific combination of time,
temperature and steam. When there is no ncg in the chamber, steam will
penetrate the pack rapidly and completely and the indicator will show a
uniform colour change. When ncg is present, it will collect towards the
centre of the pack as a bubble which will impair contact between the steam
and the indicator. The temperature or moisture level (or both) will be lower
in the region of the bubble and will result in a non-uniform colour change
of the indicator.

When used in conjunction with a standard test pack, Class B indicators

are designed to show a failure if, at the start of the holding time, either the
temperature at the centre of the test pack is 2°C or more below the
temperature at the coldest point in the chamber, or the indicator is exposed
to insufficient moisture. Both conditions are usually caused by the presence
of ncg.

When used in conjunction with an alternative test pack, Class B

indicators shall show an uneven colour change when there is sufficient ncg
present in the chamber to cause a 2°C temperature depression at the centre
of a standard test pack.

Note: in order to detect a temperature difference of 2°C, the indicator

may show signs of failure with a smaller temperature difference.

24
Daily and weekly tests - the User.

Test procedure

Use only the test pack specified by the manufacturer.

If a standard test pack is specified it should be as described in A.8 with a

20
Class B chemical indicator conforming with EN867 inserted between the
sheets nearest to the centre of the pack.

Place the test pack in the position which the sterilizer manufacturer
identifies as being the most difficult from which to remove air from the
load.

Select a standard cycle or the cycle specified by the sterilizer manufacturer.

(The test should be performed always using the same cycle).

At the end of the test, examine the test sheet. The test is satisfactory if the
indicator shows a uniform colour change.

A successful test does not confirm that sterilizing conditions in the load
have been achieved. If the test result is unsatisfactory, the reason
should be investigated [this might require thermometric testing by a
TP(s)] and the machine must not be used until the fault has been
rectified.

The result of the test should be recorded in the sterilizer log book and the
indicator paper should be marked with the result and kept for reference for
at least three months. It should be stored according to the manufacturer’s
instructions.

A.2 Automatic control test

The automatic control test is the main test for ensuring that the sterilizer
continues to function correctly as shown by values of the cycle variables.
These may be indicated by the gauges fitted to the sterilizer, or obtained
from the recorder. This test is part of the commissioning, weekly, quarterly
and annual test programmes.

The test is performed daily by the User if the sterilizer is not equipped with
a recorder but, if it is fitted with a recorder, the test may be performed
weekly by the User, with the agreement of the TP(s). It must be performed
quarterly and annually by the TP(s).

25
 Test procedure

Place a standard test pack as described in A.8 (or an alternative test pack
defined by the sterilizer manufacturer - A.8, Note 4) in the chamber, in the
position specified by the sterilizer manufacturer.

Select the sterilization temperature for the operating cycle to be tested - this
should be the highest temperature compatible with the load. Start the cycle.

Ensure that a batch process record is made:

A.2.1 Daily test - without a recorder.

Observe and note the elapsed time, and indicated chamber

temperatures and pressures at all significant points of the operating
cycle, eg the beginning and end of each stage or substage, and the
maximum values during the holding time. At the approximate mid-
point of the plateau period note the elapsed time and indicated
chamber temperature and pressure.

A.2.2 Weekly test - with a recorder.

Ensure that a batch process record is made by the recorder. At the

approximate mid-point of the plateau period note the elapsed time
and indicated chamber temperature and pressure. (Indicated values
are also required in addition to the recorder chart in order to satisfy
clause A.2.6, below.)

Note: It is the MDA’s opinion that this type of sterilizer should be

equipped with pressure and temperature recorders.

The test can be considered satisfactory if:

A.2.3 a visual display of “cycle complete” is indicated;

A.2.4 during the whole of the cycle the values of the cycle variables, as
shown on the batch process record, are within the limits
established by the manufacturer as giving satisfactory results, or
within the limits previously established on the MPR;

A.2.5 the indicated and recorded chamber temperature are within the
appropriate sterilization temperature band specified in Table 7,
p.27;

26
A.2.6 during the plateau period determined from the recorded chamber
temperature:

(i) the difference between the indicated and recorded chamber

temperature does not exceed 2°C;

(ii) the difference between the indicated and recorded chamber

pressure does not exceed 0.1 bar;

A.2.8 the door cannot be opened until the cycle is complete;

A.2.9 no mechanical or other anomaly is observed.

TABLE 7

STERILIZATION TEMPERATURE BANDS WITH HOLDING TIMES

Sterilization temperature [°C]* 121 126 134

Maximum allowable temperature [°C] 124 129 137

Minimum holding time [min] 15 10 3

*The temperature setting on the automatic controller will generally be a

higher temperature within the sterilization temperature band.

A.3 Air leakage tests - User and Test Person

Note: HTM 2010 refers to this test as the vacuum leak test.

This test forms part of the commissioning, weekly, quarterly and annual
test requirements.

Leakage of air into the chamber at a rate greater than that specified by the
sterilizer manufacturer is unacceptable because:

l
the presence of air may inhibit the penetration of steam into
the load and prevent sterilization;

l
air leaking into the chamber during the drying stages will not
have passed through the bacterial retentive filter and there is
a risk of recontaminating the load.

During the test, the rate of change of vacuum in the chamber is measured
after all valves leading to it have been closed and the vacuum source
isolated.

27
 The test may be performed weekly either by the User, using an automatic
test cycle incorporated into the sterilizer, or by a TP(s) using the manual
test.

The quarterly and annual air leakage test must be performed by a TP(s)
using both the automatic method and the manual method. Conditions
which cause a failure to be indicated during manual testing shall also
cause a failure to be indicated by the automatic testing system.

A machine which fails to meet the requirements of this test should not
be used until the fault has been rectified and the test satisfactorily
completed.

Test procedure

A.3.1 Automatic test - User

This is a weekly test that may be performed by the User, using automatic
test cycles incorporated into the sterilizer. The test should be performed
according to the sterilizer manufacturer’s instructions.

The sterilizer shall indicate clearly whether the test result is a pass or fail
and shall indicate a pass only if the absolute pressure at the end of the
vacuum stage is within the limits specified by the manufacturer, and the
rate of pressure rise during the test is not greater than 1.3 mbar per minute.

A.3.2 Manual test - Test Person

This test method is described in HTM2010 : Part 3 paragraphs 11.1 to

11.18.

The test should be considered satisfactory if the absolute pressure at the

start of the 10 minute period is within the limits specified by the
manufacturer and the rate of pressure rise during the test is not greater than
1.3 mbar per minute.

A.4 Chamber wall temperature test

This test is intended to prevent superheating by demonstrating that the

chamber wall temperature is below the sterilizing temperature at the
beginning of the cycle.

Temperatures and pressures should be recorded by independent measuring

equipment.

28
Test procedure

Place one thermocouple in each of the following positions:

l on the chamber wall at the hottest point as defined by the

manufacturer

l in the active chamber discharge or usable space as defined by

the manufacturer

The test is performed with the chamber empty. Select and start the cycle
which has the highest operating temperature and drying stage. When the
cycle is complete, immediately start a second cycle. The test result should
be considered acceptable if the temperatures and pressures recorded during
the holding time of each cycle are within the limits specified in Table 7 and
the chamber wall temperature at the beginning of the second cycle is below
the sterilizing temperature.

A.5 Thermometric tests (small and full porous loads

and solid load)

Thermometric tests for small, full and solid loads form part of the
commissioning and annual test programmes; the small load test is
performed additionally, as part of the quarterly test programme. These tests
are intended to demonstrate that after the air removal stage of the operating
cycle, at the levels at which the cycle variables are set, steam penetrates
rapidly and evenly throughout a specified test load and that the sterilizing
conditions are achieved.

The test should be performed:

l at each of the sterilization temperatures available on the

sterilizer, and a standard drying time;

l
after a warm-up cycle, with drying (in order to achieve
consistent results);

l with the test pack placed in the usable space according to the
manufacturer’s operating instructions.

29
 A.5.1 Small load test

Test procedure
l
The method is described in HTM 2010 : Part 3 , 13.7 to 13.14 but with 13.9
and 13.10 replaced by the following:

Use a standard test pack conforming with A.8, or an alternative test pack
(A.8, Note 4). Place one temperature sensor at each of the three following
positions:

l the approximate centre of the test pack, carefully arranging

the wire so that steam does not track along it and place the
assembly in the position identified by the sterilizer
manufacturer as the most difficult to sterilize;

l the coldest point in the chamber as identified by the

manufacturer (this may be the active chamber discharge);

l
the free space above the approximate geometrical centre of
the pack.
1
The acceptance criteria are as stated in HTM 2010 : Part 3 , 13.24.

A.5.2 Full load test

Test procedure

This test forms part of the commissioning and annual test programmes.
1
The test method described in HTM 2010 : Part 3 , 13.15 to 13.24 but with
13.19 and 13.20 replaced by the following:

Use the test pack specified by the sterilizer manufacturer. This may be
either a standard test pack conforming with A.8, or an alternative test pack
(A.8, Note 4). Place one temperature sensor at each of the three positions
specified in A.5.1.

Load the rest of the usable space with porous material according to the
instructions of the sterilizer manufacturer.
1
The acceptance criteria are specified in HTM 2010 : Part 3 , 13.24.

A.5.3 Solid load test

The solid load is designed to represent the maximum mass of metal instruments
which the sterilizer manufacturer specifies can be processed in the sterilizer. It is
used to demonstrate that, at the levels at which the cycle variables are set, rapid and
even penetration of steam throughout the load occurs and the sterilizing condition
is achieved.
30
 21
The solid load consists of M12x100 hexagon head screws to ISO 4017 ,
22
made from austenitic stainless steel to EN 10088-1 , wrapped in multi-
23
layer packaging conforming with EN868 .

Test procedure

Place one temperature sensor at each of the following positions:

l
attached to one of the screws using a single layer of
autoclave tape with a width less than 25mm;

l
at the coldest point in the chamber as identified by the
manufacturer (this may be the active chamber discharge);

l
in the free space above the approximate centre of the pack.

Place the screw with the temperature sensor at the approximate centre of
the test pack and place the pack centrally in the usable space. Immediately
start the sterilization cycle. At the end of the cycle, the test is satisfactory
if, throughout the holding time, the temperatures in the load and the usable
space:

l
are not lower than the sterilization temperature;

l
are not more than 3°C above the sterilization temperature;

l
do not fluctuate by more than +/- 1.5°C;

l
do not differ from each other by more than 2°C.

A.6 Load dryness test

This test is used to check that a normal operating cycle, incorporating a

drying stage, will produce a product that is sufficiently dry. It forms part of
the commissioning and annual test programmes.

A.6.1 Porous load

1
The test procedure described in HTM 2010 : Part 3 , paragraphs 13.25 to
13.35, should be used in conjunction with a standard test pack as described
in A.8, or an alternative test pack (A.8, Note 4).

A.6.2 Solid load

The test load is the solid load test pack. The test should be conducted for
each available cycle which has a drying stage. The test is successful if at
the end of the test there is no visible condensate present and the weight
gain is less than 1%.

31
 A.7 Microbiological test for Performance Qualification

For some loads, eg lengths of polymeric (including rubber) tubing or other

devices with lumens, thermometric monitoring of the adequacy of air
removal may not be appropriate as residual static air in the tubing may be
heated by conduction. For this type of load, the advice of an AP(s) and a
suitably qualified microbiologist should be sought.

A.8 Standard test pack

This is intended for use in small porous load sterilizers with chamber
volumes between 10 and 54 litres and with an internal diameter (or, for
rectangular vessels, an inscribed circle) greater than 180 mm.

1. The pack shall be constructed from plain cotton sheets complying

24
with BS 5815 , bleached to a good white, and each having an
approximate size of 450mm x 300mm. Edges other than selvedges
shall be oversewn, not hemmed.
-2
2. The mass per unit area of the sheets shall be approximately 180g m .

3. The sheets shall be washed when new and when soiled. During the
washing process the sheets shall not be subjected to any fabric
conditioning agent.

4. After washing, the sheets shall be dried and aired but not ironed or
calendered.

5. Before use, the sheets shall be stored unfolded and well separated,
for at least 1 hour at a temperature between 15°C and 25°C and at a
relative humidity (RH) of 45% to 55%.

6. The sheets shall be folded to approximately 110mm x 150mm and

stacked to a height of approximately 120mm after compressing by
hand. The pack shall be wrapped in a single sheet of the same fabric
and secured with a tape not exceeding 18mm in width. The total mass
of the pack shall be 900g±100g.

Note 1: When forming the pack, consecutive sheets should be stacked

with the folded side alternating to ensure an even stack.

Note 2: Packs which are not used within one hour of preparation may be
stored until required, providing the environmental conditions are
maintained within the limits specified above.

32
Note 3: With repeated use the sheets will become compressed. When the
mass of sheets used to form a stack 120mm high exceeds 1000g,
the sheets should be discarded.

Note 4: The standard test pack should not be used if its volume is more
than one fifth of the usable chamber space; in such cases a
smaller version of the pack may be used. This should be of
cuboid form and its volume should be about one fifth of the
usable chamber volume. It may be made from a different
material, and be of different size and weight, from the standard
test pack, provided its performance can be demonstrated to be
equivalent to that of the standard test pack in each test for which
it is to be used.

Note 5: The cotton test sheets should be stored at a relative humidity

(RH) of between 45% and 55% as sheets which have been stored
outside these limits (but within the limits 30% to 70% RH
specified in HTM2010) have been found to give variable and
misleading results in thermometric testing. Paper test packs,
however, appear to give results which are less dependent on the
RH of the storage conditions.

Cotton sheets having the recommended RH may be obtained by

storing the sheets above a saturated solution of magnesium
nitrate in a sealed container for at least 12 hours before use.
Sheets that have been conditioned may be stored in a
hermetically sealed container (eg for transportation to site)
where they will retain the correct humidity for 24 hours.

Further information and details should be sought from an AP(s).

ANNEX B
European Directive
6
The purpose of the Medical Devices Directive (93/42/EEC) is to remove
barriers to trade in medical devices throughout the European Union, and to
provide assurance that the devices perform their intended function as safely
as possible. The Directive has been transposed into UK law by the Medical
25
Device Regulations (SI 1994 no. 3017) which come fully into force on 14
June 1998, after the present transition period expires. After that date
manufacturers will not be able to place medical devices on the European
Community (EC) market legally, unless the devices comply with the
Directive. Medical devices that comply with the Directive will carry the CE
marking and can be freely sold throughout the EC without further control.
The CE marking may only be affixed to a product which the manufacturer

33
 claims to satisfy the Directive’s Essential Requirements of safety and
fitness for its intended purpose. Products which are manufactured to
conform with mandated harmonised European standards are presumed also
to conform with the relevant Essential Requirements.

If the manufacturer of a benchtop sterilizer intends it to be used to re-

process medical devices, the Regulations consider the sterilizer to be an
accessory to the devices. The Regulations treat accessories as medical
devices and regulate them to the same extent as their related devices.

The following standard is relevant to the validation of steam sterilizers:

European Standard BS EN 554: 1994: Sterilization of medical devices -

26
validation and routine control of sterilization by moist heat .

European Pressure Equipment Directive

After the Pressure Equipment Directive comes into force, all steam
sterilizers will have to conform if the product of their chamber volume (in
litres) multiplied by the normal operating pressure (in bar) is greater than
50 bar litres. The AP(s) or the Competent Person (Pressure Vessels) will
advise whether, and in which ways, a sterilizer is affected by this Directive.

Medical Device Directives: MDA Guidance Documents

Information Bulletins

2. The CE Marking
3. The Vigilance System
4. Conformity Assessment Procedures
5. Pre-Clinical Assessment Routes
6. The Notified Body
7. The Competent Authority
8. Information about the EC Medical Devices Directives
9. The Citizens Charter and a Code for Enforcement
10. The Classification Rules
11. CE and EFTA member states (EEA Agreement)
12. Sale and Supply of In Vitro Diagnostic Medical Devices
13. Standards
14. Compliance Cost Assessments
15. The Medical Devices, Electromagnetic Compatibility and Low
Voltage Directives
16. Information about the Packaging and packaging Waste Directive
17. Medical Devices and Medicinal Products
18a. The Medical Devices Regulations : Implications on Healthcare and

34
 other Related Establishments.
19. Own Brand Labelling and Rented Products

Please note that Bulletin Number 8 has been updated and now supersedes
Bulletin 1 which has been withdrawn from circulation.

Further information on the Medical Devices Regulations and guidance on

the Medical Devices Directives may be obtained from MDA.

ANNEX C
Pressure Systems and Transportable Gas Containers Regulations 1989

In addition to the requirements of the Medical Devices Regulations,

transportable sterilizers must comply with the Pressure Systems and
5
Transportable Gas Containers Regulations 1989 (SI 1989/2169) . The
overall intention of these Regulations is to prevent risk of injury from
stored energy as a result of failure of a pressure system or part of it.

Under these regulations all sterilizers containing pressure vessels are

subject to periodic inspection by a Competent Person (Pressure Vessels),
according to a written scheme of inspection. Where repairs or
modifications have involved any part of the pressure system (eg the
pipework, the chamber, and its fittings) the advice of a Competent Person
(pressure vessels) should be sought before the sterilizer is returned to
service.

Responsibility for compliance with the regulations is placed primarily

upon the person responsible for the management of the sterilizer.

The management’s responsibilities may be summarised as follows:

l
to define the scope of the written scheme of examination (a
written scheme may be supplied by the manufacturer);

l
to ensure that the parts of the pressure system defined in the
written scheme are examined by a Competent Person
(Pressure Vessels);

l
the management must not allow the sterilizer to be operated
unless a written scheme has been drawn up and certified as
suitable by a Competent Person (Pressure Vessels);

l
the management shall also ensure that the system is properly
maintained in good repair, so as to prevent danger.

The Competent Person (Pressure Vessels) has three principal duties under
the Regulations:

35
 l
advising on the scope of the written scheme of examination;
l
drawing up the written scheme of examination or certifying
the scheme as being suitable;
l
carrying out examination in accordance with the written
scheme, assessing the results and reviewing the written
scheme for its suitability.

An Authorised Person (Sterilizers) will be able to advise on the

application of these regulations to any particular system.

ANNEX D
Sources of further information

NHS Estates
1 Trevelyan Square
Boar Lane
Leeds LS1 6AE

Tel : 0113 254 7000

The Institute of Healthcare Engineering and Estate Management,

2 Abingdon House,
Cumberland Business Park,
Northumberland Road,
Portsmouth P05 1DS

Tel: 01705 823186

National Accreditation of Inspection Bodies

United Kingdom Accreditation Service
Queens Road
Teddington
Middlesex TW11 0NA

Tel: 0181 943 6657

The Association of Sterilizer and Disinfector Manufacturers

St Georges House
195-203 Waterloo Road
London SE1 8WD

Tel : 0171 787 3060

Fax : 0171 787 3061

36
The Health and Safety Executive
Field Operations Division
14 Cardiff Road
Luton
Bedfordshire LU1 1PP

Tel : 01582 444200

Fax : 01582 444320

ANNEX E
MDA Publications relevant to sterilization

1. MDA DB 9501 January 1995. The Reuse of Medical Devices

Supplied for Single use only.

2. MDA DB 9605 June 1996. The purchase, operation and maintenance

of benchtop steam sterilizers.

3. MDA DB 9607 November 1996. Decontamination of Endoscopes.

4. FPN 654 / SAB(94)22 Instruments and Appliances Used in the

Vagina and Cervix.

5. Sterilization, Disinfection and Cleaning of Medical Equipment :

guidance on Decontamination from the Microbiology Advisory
Committee to the Department of Health Medical Devices Agency.

6. Hazard HN 9503 Handpieces used in Phaco Microsurgical Procedures

and Their Re-usable Accessories.

7. Safety Notice SN 9618 Mediclave or Medical Clave Steam Sterilizers

- Inadequate Safety Locks.

8. Safety Notice SN 9619 Compatibility of Medical Devices and their

accessories and Reprocessing Units with Cleaning, Disinfecting and
Sterilizing Agents.

9. Safety Notice SN 9635 SES Matron Steam Sterilizers (Autoclaves),

Eschmann Equipment, Risk of Overheating or Fire.

37
 REFERENCES
1. Health Technical Memorandum 2010 Part 3: Validation and
verification. HMSO.

2. MDA DB9605. June 1996. The purchase, operation and maintenance

of benchtop steam sterilizers.

3. Sterilization, disinfection and cleaning of medical equipment:

guidance on decontamination from the Microbiology Advisory
Committee to Department of Health Medical Devices Agency.

4. Health Technical Memorandum 2010 Part 1: Management Policy.

HMSO.

5. SI No 2169. The Pressure Systems and Transportable Gas Containers

Regulations HMSO 1989.

6. Council Directive 93/42/EEC 14 June 1993 concerning medical

devices. Official Journal of the European Communities, L169,vol.36,
12.7.93.

7. BS EN ISO 9001 (1994). Model for Quality Assurance in

design/development, production, installation and servicing.

8. BS EN ISO 9002 (1994). Model for Quality Assurance in production

and installation.

9. BS 3970 : Part 1 : Sterilizing and disinfecting equipment for medical

products. Part 1. Specification for general requirements.

10. BS EN 61010-l Safety requirements for electrical equipment for

measurement, control, and laboratory use. Part 1: 1993 : General
requirements

11. BS EN 61010-2-041 Safety requirements for electrical equipment for

measurement, control, and laboratory use. Part 2-041 : 1997 :
Particular requirements for autoclaves using steam for the treatment of
medical materials, and for laboratory processes.

12. The Electromagnetic Compatibility Regulations (Amendment)

Regulations 1994 (SI 1994 No. 3080).

13. Draft BS EN 13060 Small steam sterilizers - Part 1: General

requirements for all types of small steam sterilizers.

14. Draft BS EN 13060 - Part 2: Particular requirements and test methods

38
 for type B sterilizers, intended for the sterilization of wrapped solid,
hollow and porous products.

15. Draft BS EN 13060 - Part 4: Particular requirements and test methods

for type S sterilizers, intended for the sterilization of products
specified by the manufacturer of the sterilizer.

16. Health Technical Memorandum 2010 Part 4: Operational

management. HMSO.

17. HC(89)20 Preservation, retention and destruction of records. (In

Scotland :MEL (1993) 152 “Guidance for retention and destruction of
Health Records”, and in Wales : WHC(89)60 and WHC(94)59).

18. Guidance Note PM 73 from the Health and Safety Executive - Safety
at Autoclaves.

19. BS 7671: 1992 Requirements for Electrical Installations.

20. BS EN 867 : 1997 Non-biological systems for use in sterilizers - Part

3 Specification for Class B indicators for use in the Bowie and Dick
test. Draft BS EN 867 Part 5 : Specification for indicator systems and
process challenge devices for use in performance testing for small
sterilizers type B and type S.

21. ISO 4017 BS EN 24017 : 1992 Hexagon head screws. Product grades
A and B

22. BS EN 10088-l : 1995 Stainless steels, Part 1 : List of stainless steels

23. EN 868 Packaging materials and systems for medical devices which
are to be sterilized

24. BS 5815 : Part 1: 1989. Specification for sheeting, sheets and

pillowslips.

25. Medical Device Regulations 1994 (SI 1994 No 3017)

26. BS EN 554: 1994. Sterilization of Medical Devices-Validation and

Routine Control of Sterilization by Moist Heat.

39
 RECENT DEVICE BULLETINS

MRI Static Magnetic Field Safety Considerations - The projectile effect caused by the
influence of the static magnetic field of magnetic resonance imaging systems
MDA DB 9803 (February 1998)

Adverse Incident Reports 1997 MDA DB 9802 (February 1998)

Medical Device and Equipment Management for Hospital and Community-based

Organisations MDA DB 9801 (January 1998)

Medical Devices and the Year 2000 MDA DB 9704 (November 1997)

Selection and Use of Infusion Devices for Ambulatory Applications

MDA DB 9703 (April 1997)

Electromagnetic Compatibility of Medical Devices with Mobile Communications

MDA DB 9702 (March 1997)

Adverse Incidents Reports 1996 MDA DB 9701 (February 1997)

Decontamination of Endoscopes MDA DB 9607 (November 1996)

Wheelchair & Vehicle Passenger Lifts: Safe Working Practices

MDA DB 9606 (September 1996)

The Purchase, Operation and Maintenance of Benchtop Steam Sterilizers

MDA DB 9605 (June 1996)

Withdrawal of MLQ Forms - England MDA DB 9604 (June 1996)

Adverse Incidents Reports 1995 MDA DB 9603 (April 1996)

Guidance of the Safe Use of Lasers in Medical and Dental Practice

MDA DB 9602 (April 1996)

Latex Sensitisation in the Health Care Setting (Use of Latex Gloves)

MDA DB 9601 (April 1996)
 REPORTING ADVERSE INCIDENTS

Incidents relating to medical devices must be reported to the Medical

Devices Agency as soon as possible.

To report an incident, for more information or printed incident report

forms contact:

MDA Adverse Incident Centre

Medical Devices Agency, Hannibal House, Elephant & Castle, London
SE1 6TQ

Telephone 0171 972 8080 or Fax 0171 972 8109

(An answer-phone service operates outside normal office hours)

Further information and incident report forms are also available on the
MDA’s Internet site http://www.medical-devices.gov.uk
 DISTRIBUTION
This Device Bulletin should be brought to the attention of managers and staff in all hospitals, liaison
officers and others who report adverse incidents.

This Device Bulletin should also be brought to the attention of all hospital and community healthcare
staff who are involved in the purchase, installation, validation and routine testing of benchtop vacuum
steam sterilizers. This will include: Sterile Services Managers, Estates Managers, Chairs of Infection
Control Committees, Infection Control Doctors, Infection Control Nurses and Consultant
Microbiologists. It will also be of interest to staff who use benchtop vacuum steam sterilizers in: GP
surgeries, dental practices, operating theatres, Intensive Care Units, Accident and Emergency
Departments and Outstations.

TECHNICAL ENQUIRIES
Enquiries concerning the content of this Device Bulletin should be addressed to :

Mr R Havard Mr M Glasspool
Medical Devices Agency Medical Devices Agency
Hannibal House Hannibal House
Elephant and Castle Elephant and Castle
London SE1 6TQ London SE1 6TQ
Tel : 0171 972 8163 Tel : 0171 972 8174
Fax : 0171 972 8106 Fax : 0171 972 8106

HOW TO OBTAIN COPIES

Copies of this Device Bulletin are free to the NHS and may be obtained on written request from :

Department of Health
PO Box 410
Wetherby
LS23 7LN
Fax : 0990 210266
quoting reference MDA DB9804

Otherwise, copies of the bulletin at a charge of £25.00 per copy, may be obtained from:

Medical Devices Agency

MDA/DTS Orders
Level 9
Hannibal House
Elephant and Castle
London SE1 6TQ

© CROWN COPYRIGHT 1998

Medical Devices Agency
An Executive Agency of the Department of Health

13387 MDA 8K JUL 98 SA (ABB)