Académique Documents
Professionnel Documents
Culture Documents
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.
l
the equipment complies with safety requirements and it is
installed and maintained appropriately;
l
operators are trained;
l
daily testing;
l weekly testing.
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’ .
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
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
Is any person with the authority to operate a sterilizer, including the noting
of sterilizer instrument readings and simple housekeeping duties.
3
1.2 Testing:
is the removal of air from the chamber using mechanical means eg vacuum
pump.
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.
air and other gas which will not condense under the conditions of steam
sterilization.
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 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.
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.
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 .)
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.
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.
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.
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.
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.
Tests performed by the User should not require specialised test equipment.
9
4.3 Documentation
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:
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.]
The AP(s) and the User should agree in advance the procedure for handling
test failures.
Commissioning
VALIDATION
Thermometric tests
Performance qualification (PQ)
Microbiological tests
(if necessary)
Figure 1. The validation process
4.6 COMMISSIONING
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.
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.
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;
l
the manufacturer has supplied all the documents specified in
the contract, including calibration verification certificates for
the temperature and pressure instruments and controllers.
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.
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.
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.
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.
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
* HTM 2010 refers to this test as Vacuum Leak Test. See annex A, p24.
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;
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.
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.
TABLE 2
COMMISSIONING TESTS
These tests are performed by the TP(s)
16
4.7 PERFORMANCE QUALIFICATION (PQ) - the Test
Person
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.
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).
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.
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)];
TABLE 4
WEEKLY TESTS
These tests should be performed by the test person - after successful
completion of the weekly safety checks .
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.
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.
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.
l when the software used for the control of the process has
been modified;
l
when required by the User or the AP(s).
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
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.
There are two types of chemical indicator which are commonly used in
steam sterilizers:
23
ANNEX A
TEST METHODS
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.
24
Daily and weekly tests - the User.
Test procedure
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.
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.
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.
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:
TABLE 7
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
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.
28
Test procedure
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.
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.
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 free space above the approximate geometrical centre of
the pack.
1
The acceptance criteria are as stated in HTM 2010 : Part 3 , 13.24.
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.
Test procedure
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.
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
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.
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%.
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.
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.
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.
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.
ANNEX C
Pressure Systems and Transportable Gas Containers Regulations 1989
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.
ANNEX D
Sources of further information
NHS Estates
1 Trevelyan Square
Boar Lane
Leeds LS1 6AE
36
The Health and Safety Executive
Field Operations Division
14 Cardiff Road
Luton
Bedfordshire LU1 1PP
ANNEX E
MDA Publications relevant to sterilization
37
REFERENCES
1. Health Technical Memorandum 2010 Part 3: Validation and
verification. HMSO.
38
for type B sterilizers, intended for the sterilization of wrapped solid,
hollow and porous products.
18. Guidance Note PM 73 from the Health and Safety Executive - Safety
at Autoclaves.
21. ISO 4017 BS EN 24017 : 1992 Hexagon head screws. Product grades
A and B
23. EN 868 Packaging materials and systems for medical devices which
are to be sterilized
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)
Medical Devices and the Year 2000 MDA DB 9704 (November 1997)
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
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: