Professional Documents
Culture Documents
1990
Sterilizing and
disinfecting equipment
for medical products —
Part 5: Specification for low
temperature steam disinfectors
Confirmed
December 2011
BS 3970-5:1990
The preparation of this British Standard was entrusted by the Health Care
Standards Policy Committee (HCC/-) to Technical Committee HCC/14, upon
which the following bodies were represented:
© BSI 03-1999
Amd. No. Date of issue Comments
Contents
Page
Committees responsible Inside front cover
Foreword ii
1 Scope 1
2 Definitions 1
3 General requirements 1
4 Design pressure 1
5 Operating cycle 1
6 Instrumentation and controls 2
7 Performance requirements 3
Appendix A Chamber temperature test 4
Appendix B Air ingress monitor test 4
Appendix C Small load test 4
Appendix D Full load test 5
Appendix E Load dryness test 5
Appendix F Leak rate test 6
Appendix G Over-temperature cut-out test 6
Publications referred to Inside back cover
© BSI 03-1999 i
BS 3970-5:1990
Foreword
1)
In preparation; each Part will be allocated a number in its respective order of publication.
ii © BSI 03-1999
BS 3970-5:1990
Summary of pages
This document comprises a front cover, an inside front cover, pages i to iv,
pages 1 to 8, an inside back cover and a back cover.
This standard has been updated (see copyright date) and may have had
amendments incorporated. This will be indicated in the amendment table on
the inside front cover.
2)
1 bar = 105 N/m2 = 105 Pa.
© BSI 03-1999 1
BS 3970-5:1990
If the load is dried by injecting heated gases into There shall be an indication, visible to the operator,
the chamber, the gases shall be filtered when the leak test timer is operating.
(see clause 15 of BS 3970-1) and the temperature At the end of the leak test cycle the automatic
of the injected gas shall not exceed 80 °C; the controller shall indicate a “FAULT”.
duration of the drying stage (stage 6) shall be not NOTE 2 The automatic controller may also indicate that the
less than 3 min and the chamber pressure at the leak test cycle has been completed.
end of stage 6 shall attain 40 mbar absolute or Compliance is checked as described in Appendix F.
less.
g) Stage 7: Air admission. Air shall be admitted 6 Instrumentation and controls
to the chamber through the filter (see clause 15 of
6.1 Instruments and control equipment
BS 3970-1) until the chamber pressure is
additional to that specified in BS 3970-1
within 100 mbar of atmospheric pressure.
The duration of the specified overall cycle time 6.1.1 If an indicating thermometer is fitted to
(stage 2 to stage 7 inclusive) shall not exceed 60 min monitor the temperature of the chamber wall, the
(see note). sensor for this thermometer shall be attached either
to the chamber wall or, if a jacket is fitted, within
NOTE The specified overall cycle time includes the drying,
i.e. stage 6, that is required to achieve a dry load with the test the jacket space.
load described in Appendix C. However in practice, other loads 6.1.2 A system for controlling additional drying time
may be more difficult to dry and thus are likely to require
extended drying times (see 6.1.2) leading to an extension of the
shall be fitted to enable stage 6 to be extended
overall cycle time. by 20 min or less (see note to 5.1).
Compliance is checked by inspection and as 6.1.3 A monitoring timer shall be fitted so that if the
described in Appendix A, Appendix B, Appendix C, combined time for stages 4 and 5 exceeds the
Appendix D and Appendix E. disinfection time (stage 5) by more than 3 min, a
fault is indicated.
5.2 Leak test cycle
6.1.4 A leak test timer shall be fitted, capable of
The disinfector shall be provided with the facility for
indicating periods of at least 20 min to an accuracy
a leak test cycle under the control of the automatic
of ± 10 s.
controller. Selection of this cycle shall only be
accessible to the operator by means of a special key, 6.1.5 Over-temperature cut-outs shall be fitted, in
code or tool. addition to those specified in BS 3970-1. These
NOTE 1 The leak test cycle may be incorporated by
cut-outs shall ensure that the chamber wall and the
modification of stage 2, stage 3 or stage 6 of a normal operating chamber free space will not exceed 80 °C. The
cycle. If the leak test cycle is achieved by modification of stage 2 cut-outs shall effect this by disconnecting the source
or stage 3, the leak test cycle may exclude stages 4 to 7 inclusive of heat to the chamber and, if necessary, to the
of the normal operating cycle.
chamber walls or, if fitted, to the jacket; and the
Selection of the leak test cycle shall initiate the operating cycle shall proceed immediately to stage 6
following operations carried out in sequence with no and a fault shall be indicated.
load in the chamber.
Compliance is checked as described in Appendix G.
a) The pressure in the chamber is reduced to
less than 40 mbar. (See also note to B.2.1.) 6.2 Additional requirements for instruments
and control equipment specified in BS 3970-1
b) All the valves directly connected to the
chamber are closed. 6.2.1 Means shall be provided for recording the
chamber temperature throughout the operating
c) Either the vacuum pump is stopped or, if the
cycle (see 6.2.3). The temperature scale range shall
vacuum source is external to the machine, a
be 0 °C to 100 °C.
second valve isolating the evacuated chamber is
closed. The recording instrument shall comply with 13.3 of
BS 3970-1. The speed of the imprint surface shall be
d) The isolating valve, if fitted between the
not less than 2 mm/min at the disinfecting
chamber and the absolute pressure gauge, is
temperature.
opened and remains open for a period of not
less than 15 min and not more than 20 min, 6.2.2 The chamber pressure recorder, as specified
the period being monitored by a leak test timer in 13.3 of BS 3970-1, shall have a scale range
(see Appendix B). from 0 bar to 1 bar absolute. The chart speed shall
be the same as that of the chamber temperature
e) After this period, air is admitted to the
recorder (see 6.2.1).
chamber through the filter (see clause 15 of
BS 3970-1) until the chamber pressure is
within 100 mbar of atmospheric pressure.
2 © BSI 03-1999
BS 3970-5:1990
6.2.3 The chamber temperature indicating c) Throughout stage 5, the temperatures of the
thermometer, as specified in 13.2.1 of nominal geometric centre of the small load test
BS 3970-1:1990 shall have, in addition, a scale pack, the active chamber discharge and the
range not exceeding 100 °C (see 6.2.1). chamber free space shall be not lower than 71 °C.
6.2.4 The chamber pressure gauge, as specified d) The operating cycle shall be completed
in 13.2.3 of BS 3970-1, shall have a gauge pressure within 60 min of the start of stage 2.
scale range of – 1 bar to not less than 0 bar, or a Failure to comply with any of the requirements
pressure scale range of 0 bar absolute to not less specified in items a) to d) shall lead to the
than 1 bar absolute. indication of a fault.
6.2.5 An absolute pressure indicator, as specified 7.3 Performance using a full load test pack
in 13.2.5 of BS 3970-1, shall be fitted to the chamber
for the purposes of the leak rate test When tested as described in Appendix D, the
(see Appendix F). disinfector shall comply with the following
requirements.
7 Performance requirements a) Throughout stage 5, the temperature at the
nominal geometric centre of the full load test
7.1 Chamber temperature
pack shall be not lower than 71 °C and not
When tested as described in Appendix A, the greater than 80 °C.
removal of air (stage 2) shall not commence until the
b) Throughout stage 5, the temperatures at the
temperatures indicated by the
nominal geometric centre of the full load test
sensors [A.2.1 a) and b)] are between 71 °C
pack and the active chamber discharge shall be
and 78 °C. Not more than 5 min after the start of the
not lower than 71 °C.
disinfection stage (stage 5) and thereafter until the
end of stage 5, the temperatures indicated by all the c) The operating cycle shall be completed
sensors shall be not less than the temperature of the within 60 min of the start of stage 2.
active chamber discharge. Failure to comply with any of the requirements
7.2 Performance using a small load test pack specified in items a) to c) shall lead to the
indication of a fault.
When tested as described in Appendix C, the
disinfector shall comply with the following 7.4 Load dryness
requirements. When a fabric load is tested as described in
a) Throughout stage 5 the temperature at the Appendix E, its mass after the operating cycle shall
nominal geometric centre of the small load test not exceed its mass before undergoing the operating
pack shall be not lower than 71 °C and not cycle by more than 1% (m/m).
greater than 80 °C. 7.5 Air leakage
b) Throughout stage 5, the temperature in the When tested as described in Appendix F, the
chamber free space shall not differ by disinfector shall achieve an absolute pressure of
more than 4.0 °C from the temperature at the less than 40 mbar in the empty chamber and
active chamber discharge. subsequent air ingress shall not cause the pressure
to increase at a rate greater than 0.5 mbar/min after
the initial stabilizing period of 5 min.
© BSI 03-1999 3
BS 3970-5:1990
4 © BSI 03-1999
BS 3970-5:1990
C.2.2 Immediately before the test, unfold each C.3.7 At the completion of the test, examine the
towel (C.1.1) and allow to air for at least 1 h in an temperature records for compliance with 7.2.
atmosphere at between 15 °C and 25 °C and a
relative humidity of between 30 % and 70 %. Then Appendix D Full load test (see 7.3)
fold each towel in half, three times, to provide eight
thicknesses with a nominal area D.1 Apparatus and materials
of 300 mm × 225 mm. Form a small load test pack D.1.1 Fabric material, laundered without the
by placing not more than 36 towels horizontally, one addition of starch or fabric conditioner, aired and
above another, to form a stack 265 ± 15 mm high. If having a mean density of between 150 kg/m3
more than 36 towels are needed to give the required and 170 kg/m3.
height, replace the worn towels. NOTE The fabric should be predominantly cotton or linen and
NOTE The exact number of towels required will depend on how should contain not more than 20 % (m/m) of synthetic fibre.
often the towels have been laundered. With new towels of fabric D.1.2 Small load test pack, as described in C.2
reference 1.6 at least 25 are likely to be needed.
and C.3.3.
C.3 Procedure
D.1.3 Recording thermometer, with a minimum of
C.3.1 Introduce monitoring thermocouples into the two sensors; with an accuracy of not less than 0.5 %
chamber through the thermocouple entry at the maximum of the scale range 0 °C to 150 °C,
connection, and then carry out the air leakage test and with an accuracy of ± 0.25 °C within the
as described in Appendix F. Do not proceed with the range 73 ± 5 °C.
small load test if the air leakage is greater
than 5 mbar in 10 min. The thermometer records either:
C.3.2 After a successful air leakage test, carry out a) continuously, with a chart speed of not
at least one normal operating cycle with the less than 20 mm/min; or
chamber empty except for the fixed furniture. b) at intervals, not exceeding 6 s for each channel.
C.3.3 Place one of the temperature sensors (C.1.2) D.2 Procedure
at the nominal geometric centre of the small load D.2.1 Load the usable chamber space with the fabric
test pack (C.2). Compress the stack of towels by material (D.1.1) and with a small load test
hand pressure and secure the stack by one of the pack (D.1.2). Position the small load test pack at the
following methods: nominal geometric centre of the usable chamber
a) placing in a casket complying with BS 3281; or space.
b) wrapping in sterilization grade paper, Ensure that the mass of the load corresponds
complying with BS 6254 or BS 6255; or to 160 ± 10 kg for each cubic metre of the usable
c) tying with tapes or cords. chamber space, and that two temperature sensors
are located as described in C.3.3 and C.3.4.
Ensure that, when handled, the pack is stable and
the towels are secure. D.2.2 Carry out an operating cycle, recording the
elapsed time for each stage and the monitored
Place the complete test pack with the centre of the temperatures in the small load test pack and the
bottom of the test pack at between 100 mm drain.
and 200 mm above the nominal geometric centre of
the chamber base. D.2.3 At the completion of the test, examine the
temperature records for compliance with 7.3.
C.3.4 Secure the second temperature sensor in the
active chamber discharge in contact with the Appendix E Load dryness test (see 7.4)
condensate to a depth of at least 10 mm.
C.3.5 Secure the third temperature sensor in the E.1 Apparatus and materials
chamber free space between 45 mm and 55 mm E.1.1 Small load test pack, as described in C.2
above the upper surface of the test pack and and C.3.3, but not including the temperature
approximately above the nominal geometric centre sensors.
of the test pack.
E.1.2 Polyethylene bags, three, 350 mm × 250 mm
C.3.6 Carry out an operating cycle with the chamber or larger, manufactured from polyethylene sheets
containing only the small load test pack, the with a thickness of not less than 250 4m.
temperature sensors and the fixed chamber
E.1.3 Balance, capable of weighing loads of up
furniture. Observe and record the elapsed time for
to 1 kg with an accuracy of ± 0.1 g, or better.
each stage and the monitored temperatures in the
small load test pack, the active chamber discharge E.1.4 Indelible marker.
and the chamber free space.
© BSI 03-1999 5
BS 3970-5:1990
6 © BSI 03-1999
BS 3970-5:1990
G.2.3 With the chamber empty except for its fixed c) none of the recorded temperatures
furniture and the temperature sensors, start an exceeds 80 °C; and
operating cycle. d) a fault is indicated.
G.2.4 Check that when the over-temperature G.2.5 Re-activate the chamber temperature control
cut-out (see 6.1.5) operates: system and inactivate the chamber wall control
a) the heat source to the disinfector is system. Then repeat G.2.2 to G.2.4.
disconnected; G.3 Reporting of results
b) the operating cycle proceeds immediately to Report whether or not the disinfector performed as
stage 6; described in G.2.4 and G.2.5.
© BSI 03-1999 7
8 blank
BS 3970-5:1990
Publications referred to
3)
Referred to in foreword only.
4)
Available from HMSO, 49 High Holborn, London WC1 for personal callers or by post from HMSO, PO Box 276,
London SW8 5DT.
5) Available from DHSS (Leaflets), PO Box 21, Stanmore, Middlesex, HA5 1AY.
© BSI 03-1999
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