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BRITISH STANDARD BS 3970-5:

1990

Sterilizing and
disinfecting equipment
for medical products —
Part 5: Specification for low
temperature steam disinfectors

Confirmed
December 2011
BS 3970-5:1990

Committees responsible for this


British Standard

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:

Associated Offices Technical Committee


Association of British Health-Care Industries
Association of British Sterilizer Manufacturers
Association of Clinical Pathologists
Association of National Health Service Supplies Officers
British Dental Trade Association
British Surgical Trades Association
Central Sterilising Club
Department of Health
Guild of Hospital Pharmacists
Health and Safety Executive
Infection Control Nurses’ Association
Institute of Hospital Engineering
Institute of Purchasing and Supply
Institute of Sterile Services Management
Joint Committee of Professional Nursing, Midwifery and Health Visiting
Associations (England)
Medical Sterile Products Association
National Blood Transfusion Service
Public Health Laboratory Service
Regional Hospital Boards Engineers’ Association
Royal College of Pathologists
Royal Pharmaceutical Society of Great Britain
Scottish Health Services
Stainless Steel Fabricators’ Association of Great Britain

This British Standard, having


been prepared under the
direction of the Health Care
Standards Policy Committee,
was published under the
authority of the Board of BSI
and comes into effect on Amendments issued since publication
28 September 1990

© BSI 03-1999
Amd. No. Date of issue Comments

The following BSI references


relate to the work on this
standard:
Committee reference HCC/14
Draft for comment 85/53989 DC

ISBN 0 580 18508 7


BS 3970-5:1990

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

It is recommended that this foreword be read in conjunction with the foreword of


BS 3970-1.
This Part of BS 3970 has been prepared under the direction of the Health Care
Standards Policy Committee. It forms part of BS 3970, which specifies
requirements for a range of sterilizing and disinfecting equipment intended for
medical and related uses.
The general requirements applicable to all the sterilizers and disinfectors covered
by this standard are given in Part 1. Those requirements that are not common to
most types of sterilizer or disinfector are specified in subsequent Parts of
BS 3970. These Parts, giving particular requirements, should be read in
conjunction with BS 3970-1:1990 which they supplement or modify. The titles of
these Parts are expected to be as follows:
— Part 3: Specification for steam sterilizers for wrapped goods and porous
loads;
— Part 4: Specification for transportable steam sterilizers for unwrapped
instruments and utensils;
— Part A1): Specification for steam sterilizers for fluids in sealed rigid
containers;
— Part B1): Specification for steam sterilizers for fluids in unsealed vented
containers;
— Part C1): Specification for steam sterilizers for fluids in sealed non-rigid
containers;
— Part D1): Specification for sterilizers using low-temperature steam with
formaldehyde;
— Part E1): Specification for sterilizers using ethylene oxide or ethylene oxide
mixtures.
This Part specifies requirements, in addition to those specified in BS 3970-1, for
equipment operating at sub-atmospheric pressures and designed to disinfect heat
sensitive products by using saturated steam at low temperature in the absence of
formaldehyde (see note). The process described achieves disinfection only. The
equipment specified in this Part of BS 3970 is intended for treating both wrapped
or unwrapped instruments and for those materials unsuitable for treatment at
temperatures above 80 °C. Only one operating cycle is specified; process control
is fully automatic.
It is necessary to ensure that the walls of the chamber are heated prior to
commencing stage 2 in order to minimize condensation and to achieve the correct
conditions for disinfection. Also, for successful disinfection, it is usual to have an
efficient vacuum system both to ensure steam penetration during stage 5 of the
operating cycle and to ensure that the pressure during stage 6 is sufficiently
reduced to enable the moisture to be removed from the load (see clause 5).
NOTE Although this practice is deprecated, the operating cycle specified in this standard is usually
provided as an alternative operating cycle on equipment designed for sterilization by low temperature
steam with formaldehyde. It is for this reason that this Part is included in BS 3970. The Part of
BS 3970 specifying low temperature steam sterilizers using formaldehyde is being considered at the
time of publication of this Part of BS 3970.
Attention is drawn to the fact that the production of dry packs is assisted by the
use of suitable absorbent packaging materials. Guidance in the treatment of wet
loads is given in Health Technical Memorandum (HTM) 10 “Sterilizers”,
published by the Department of Health and Social Security.

1)
In preparation; each Part will be allocated a number in its respective order of publication.

ii © BSI 03-1999
BS 3970-5:1990

Product certification. Users of this British Standard are advised to consider


the desirability of third party certification for product conformity with this
British Standard, based on testing and continuing surveillance which may be
coupled with assessment of a supplier’s quality systems against the appropriate
Part of BS 5750.
Enquiries as to the availability of third party certification schemes will be
forwarded by BSI to the Association of Certification Bodies. If a third party
certification scheme does not already exist, users should consider approaching an
appropriate body from the list of Association members.
Alternatively, users of this British Standard may wish to consider the desirability
of assessment and registration of a supplier’s quality systems against the
appropriate Part of BS 5750 by a third party certification body.
A British Standard does not purport to include all the necessary provisions of a
contract. Users of British Standards are responsible for their correct application.
Compliance with a British Standard does not of itself confer immunity
from legal obligations.

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.

© BSI 03-1999 iii


iv blank
BS 3970-5:1990

1 Scope 5 Operating cycle


This Part of BS 3970 specifies particular 5.1 Cycle stages
requirements for disinfectors using a single The disinfector shall perform the following
specified operating cycle and using mains supplied operating cycle with a load of mass not
steam. These requirements apply in addition to the exceeding 170 kg for each cubic metre of the usable
general requirements specified in BS 3970-1. The chamber space. if in any of the following stages the
disinfector specified is applicable to the disinfection specified conditions are not achieved, a fault shall be
of heat labile materials (see foreword). indicated.
NOTE 1 It is emphasized that equipment complying with this
Part of BS 3970 is only designed to disinfect (see 2.2). a) Stage 1: Pre-heating. Before stage 2 can
NOTE 2 The titles of the publications referred to in this commence, the walls of the chamber shall be at a
standard are listed on the inside back cover. temperature of 71 °C to 78 °C (see 7.1).
b) Stage 2: Air removal. Sufficient air shall be
2 Definitions removed from the chamber and the load to permit
For the purposes of this Part of BS 3970, the attainment of the disinfecting conditions
definitions given in BS 3970-1 apply, together with (see 7.2 and 7.3).
the following. c) Stage 3: Air ingress monitoring. Means
2.1 shall be provided to monitor the ingress of air into
low temperature steam the chamber commencing when the pressure in
the chamber is at its lowest value. If the rate of
pure water vapour in equilibrium with liquid water
pressure increase is greater than 5 mbar/min, the
at a temperature below 100 °C
operating cycle shall proceed directly to stage 6.
NOTE In practice, low temperature steam refers in this Part of
BS 3970 to water at its boiling point at an absolute pressure
(See 7.5.)
of 350 mbar2) or 35 kPa. This pressure corresponds to d) Stage 4: Steam admission. Steam shall be
approximately 73 °C. admitted to the chamber until the temperature
2.2 attained throughout the load (see 7.2 and 7.3)
disinfection is 73 ± 2 °C.
the process used to reduce the number of viable e) Stage 5: Disinfection. During this stage the
micro-organisms in a load but which may not temperature throughout the chamber and the
necessarily inactivate some viruses and bacterial load shall be not less than the nominal
spores disinfecting temperature 73 °C for a period of not
NOTE The disinfection process may not achieve the same less than 10 min. The chamber temperature,
reduction in microbial contamination levels as sterilization. measured at the active chamber discharge, shall
be controlled at 73 ± 2 °C during this stage. In
3 General requirements addition, after the first 5 min of this stage and
3.1 Disinfectors shall comply with the requirements until the conclusion of this stage, the
of BS 3970-1, and with 3.2 and clauses 4 to 7 of this temperature of the chamber wall shall be not
Part of BS 3970. less than the temperature of the active chamber
discharge. (See 7.1, 7.2 and 7.3.)
NOTE Users of this Part of BS 3970 are advised that reference
should be made to The Electrical Safety Code for Hospital f) Stage 6: Drying. Steam shall be extracted
Laboratory Equipment (ESCHLE) as certain of its requirements from the chamber, and the chamber pressure
are specified in BS 3970-1.
shall be reduced sufficiently to permit the
3.2 Unless otherwise stated in this British evaporation of condensate from the load either by
Standard, compliance with this Part of BS 3970 prolonged evacuation of the chamber or by the
shall be checked by visual inspection and, if injection and subsequent extraction of heated air
appropriate, by direct measurement. or other gases within the chamber (see 7.4).
4 Design pressure If the load is dried without the injection of hot
gases, the duration of the drying stage shall be
The design pressure of the vessel shall permit its not less than 3 min and the chamber pressure at
operation within the gauge pressure range – 1 bar the end of stage 6 shall be not greater
to 0.2 bar2). The design pressure of the jacket, if than 40 mbar absolute.
fitted, shall be within the same limits.

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

Appendix A Chamber temperature B.2 Procedure


test (see 7.1) B.2.1 Connect the variable flow device (B.1.1) to the
disinfector chamber. With the chamber empty
A.1 Apparatus and materials except for the fixed furniture, carry out an operating
A.1.1 Temperature sensors,twelve. cycle. During stage 3, adjust the flow device to allow
A.1.2 Recording thermometer(s), with sufficient air to enter the chamber so that the pressure rise
+2
channels to connect to all the sensors (A.1.1), and is 50 – 0 mbar during a 10 min period.
with an accuracy of ± 0.25 °C within the range B.2.2 At the conclusion of the operating cycle, place
of 73 ± 5 °C. in the chamber the small load test pack (B.1.2) and
A.2 Procedure carry out another operating cycle.
A.2.1 Locate the temperature sensors (A.1.1) in the B.2.3 Check that at stage 3, the automatic
disinfector as follows. controller immediately causes the operating cycle to
proceed directly to stage 6, and that a fault is
a) Place eight sensors on the chamber walls indicated.
adjacent to each of the eight corner positions of
the usable chamber space. B.3 Results
b) Place two sensors at the geometric centre of Record whether or not the operating cycle proceeded
each side wall of the chamber. immediately to stage 6 after stage 3 started and
whether or not a fault was indicated.
c) Place one sensor in the active chamber
discharge. Appendix C Small load test (see 7.2)
d) Place one sensor on the projected geometric
centre of the steam inlet to the chamber in a C.1 Apparatus and materials
position on the rear plane of the usable chamber C.1.1 Coarse hand-towels, unbleached, of
space. huckaback weave and having a nominal size
NOTE If a steam inlet is fitted with baffles, these should not be of 900 mm × 600 mm, complying with fabric
removed when carrying out the chamber temperature test. reference 1.6 or 1.7 of BS 1781.
Then connect each of the sensors to the recording
NOTE If towels complying with fabric reference 1.7 of BS 1781
thermometer(s) (A.1.2). are used, more than 25 towels will be required to form the test
A.2.2 With the chamber empty except for its fixed pack (see C.2).
furniture and the temperature sensors, carry out an Wash new towels thoroughly to remove the dressing
operating cycle as specified in 5.1 recording the and wash soiled or discoloured towels to reinstate
temperatures indicated by each of the sensors. both cleanliness and softness. During washing, do
A.2.3 Note the temperatures of all the sensors when not use fabric softeners or conditioners and do not
stage 2 (air removal stage) commences. starch, iron or calender the towels.
A.2.4 Note the temperatures indicated by each of C.1.2 Recording thermometer, with a minimum of
the sensors for the final 5 min of stage 5 three sensors, with an accuracy of not
(disinfection stage). less than 0.5 % at the maximum of the scale
range 0 °C to 150 °C, and with an accuracy
A.3 Reporting of results of ± 0.25 °C within the range 73 ± 5 °C.
A.3.1 Record whether or not stage 2 commenced The thermometer records either:
before the temperature indicated by all the sensors
was 71 °C to 78 °C. a) continuously, with a chart speed of not
less than 20 mm/min; or
A.3.2 Record after the first 5 min of stage 5 whether
or not the temperatures indicated by all the sensors b) at intervals, not exceeding 8 s for each channel.
during stage 5 were within – 0 °C, + 5 ° C of the C.2 Assembly of the small load test pack
temperature of the active chamber discharge. C.2.1 Assemble the small load test pack afresh as
described in C.2.2 before each test.
Appendix B Air ingress monitor test
(see item c) of 5.1)
B.1 Apparatus and materials
B.1.1 Variable flow device, capable of controlling the
entry of air into the disinfector chamber.
B.1.2 Small load test pack, as described in C.2.

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

E.2 Procedure Appendix F Leak rate test (see 7.5)


E.2.1 Allow the towels of the small load test
pack (E.1.1) to equilibrate as described in C.2.2. F.1 Apparatus and equipment
E.2.2 Mark three of the towels and similarly mark F.1.1 Absolute pressure indicator, barometrically
each of the polyethylene bags (E.1.2) so that all are compensated, as specified in 6.2.5.
individually identified. F.1.2 Stopwatch, graduated in 0.2 s, and with an
Place each towel in its corresponding bag, weigh accuracy over a period of 15 min of not
each bag and record its mass (m1). less than ± 0.5 s.
E.2.3 Remove the towels from the bags and replace F.2 Procedure
them in the small load test pack; place one in the F.2.1 Stabilize the temperature of the chamber
centre and the others as the fourth towel from either (see note) by carrying out a normal operating cycle
end of the test pack. Secure the test pack as and ensure that, throughout the period in which the
described in C.3.3. chamber pressure is monitored, the temperature
E.2.4 Place the test pack in the disinfector and carry does not change by more than 10 °C.
out an operating cycle as described in C.3.6. Start NOTE In a closed vessel at 40 mbar absolute pressure, the
the operating cycle within 60 s of placing the test pressure changes by approximately 1 mbar for each 10 °C change
in temperature, over the range 20 °C to 100 °C. The test could be
pack in the disinfector chamber. Do not permit the inconclusive if the temperature changes by more than 10 °C
cycle to include any extended drying time (see note during the period in which the chamber pressure is monitored.
to 5.1). F.2.2 With the temperature stabilized and the
E.2.5 At the completion of the operating cycle and chamber empty except for its fixed furniture and
after not more than 60 s, remove the test pack from necessary monitoring sensors, select and start the
the chamber. Remove the three marked towels from leak test cycle (see 5.2). Observe and record the time
the test pack and immediately place each in its (t1) and the absolute pressure (p1) when the leak
corresponding bag. Seal each bag by turning its test timer (see 6.1.4) starts.
open end over several times. Ensure that total time F.2.3 Wait for 300 ± 10 s after t1 and then observe
taken from the end of the operating cycle to the and record the absolute pressure in the chamber
enclosure of the three towels does not exceed 3 min. (p2). After a further 600 ± 10 s, again observe and
NOTE The transfer of the towels to the polyethylene bags record the absolute pressure in the chamber (p3).
should be accomplished with the greatest possible economy of
movement in order to minimize loss of retained moisture. F.3 Results
E.2.6 Allow the towels to cool. Then weigh and Determine whether p1 is less than 40 mbar and
record the mass (m2) of each towel in its bag. whether (p3 – p2) is less than 5 mbar.
E.3 Expression of results
Appendix G Over-temperature cut-out
Calculate the moisture content of each towel, test (see 6.1.5)
expressed as a percentage, using the formula:
m2 – m1 G.1 Apparatus and materials
−−−−−−−−−−−−− × 100
m1 G.1.1 Temperature sensors, twelve.
G.1.2 Recording thermometer(s), with sufficient
where
channels to connect all the sensors (G.1.1), and with
m1 is the initial mass, in grams, of a towel in its an accuracy of ± 0.25 °C within the range 73 ± 5 °C.
bag; and (See also A.1.2.)
m2 is the finals mass, in grams, of the same G.2 Procedure
towel in its bag. G.2.1 Inactivate the chamber temperature control
system.
Report the mean of the three results and check that
the mean is not more than 1 %. G.2.2 Place the sensors (G.1.1) in the locations
described in A.2.1 and connect them to the
recording thermometer(s) (G.1.2).

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

BS 1781, Specification for linen and linen union textiles.


BS 3281, Specification for rectangular metal boxes for use in high vacuum steam sterilizers.
BS 3970, Sterilizing and disinfecting equipment for medical products.
BS 3970-1, Specification for general requirements.
BS 3970-3, Specification for steam sterilizers for wrapped goods and porous loads.
BS 5750, Quality systems3).
BS 6254, Specification for creped sterilization paper for medical use.
BS 6255, Specification for plain sterilization paper for medical use.
Health Technical Memorandum No. 10 “Sterilizers”, DHSS, 19814).
The Electrical Safety Code for Hospital Laboratory Equipment (ESCHLE), Health Equipment Information
(HEI) No. 158, DHSS, SHHD, Welsh Office and DHSS (Northern Ireland), August 19865).

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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