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GB 18282.5-2015: Sterilization of health care products -- Chemical Indicators -- Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
GB 18282.5-2015
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.080.01
C 47
GB 18282.5-2015 / ISO 11140-5:2007
Sterilization of health care products - Chemical indicators -
Part 5: Class 2 indicators for Bowie and Dick-type air
removal tests
(ISO 11140-5:2007, IDT)
ISSUED ON: DECEMBER 10, 2015
IMPLEMENTED ON: JANUARY 01, 2017
Issued by: General Administration of Quality Supervision, Inspection and
Quarantine;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword ... 3
Introduction ... 5
1 Scope ... 6
2 Normative references ... 6
3 Terms and definitions ... 6
4 General requirements ... 7
5 Indicator system ... 7
6 Indicator ... 9
7 Packaging and labelling ... 10
8 Quality assurance ... 10
9 Sampling conditioning ... 10
Appendix A (Normative) Determination of the degree of contrast between the colour of
the substrate and the indicator agent ... 11
Appendix B (Normative) Method of determining uniform colour change on exposure
to saturated steam ... 12
Appendix C (Normative) Method for determining indicator colour change on exposure
to dry heat ... 14
Appendix D (Normative) Method for determining transfer of indicator agent to standard
test pack ... 15
Appendix E (Normative) Standard test pack ... 16
Appendix F (Normative) Method of determining non-uniform colour change on
exposure to a standard fault condition ... 17
Appendix G (Normative) Steam exposure apparatus ... 19
References ... 21
Foreword
All technical contents of this Part of GB 18282 are mandatory.
GB 18282 Sterilization of health care products - Chemical indicators is divided into
the following parts:
-- Part 1: General requirements;
-- Part 3: Class 2 Indicator systems for use in the Bowie and Dick-type steam
penetration test;
-- Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for
detection of steam penetration;
-- Part 5: Class 2 indicators for Bowie and Dick-type air removal tests.
Note: GB 18282.2 Sterilization of health care products - Chemical indicators - Test
equipment and methods is replaced by GB/T 24628-2009 Sterilization of health
care products - Biological and chemical indicators - Test equipment.
This Part is Part 5 of GB 18282.
This Part was drafted in accordance with the rules given in GB/T 1.1-2009.
This Part is identical to ISO 11140-5:2007 Sterilization of health care products -
Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal
tests.
The documents of China, which have a consistent correspondence with the international
documents referenced in this Part, are as follows:
-- GB/T 12823.4-2008 Photography - Density measurement - Part 4: Geometric
conditions for reflection density (ISO 5-4:1995, IDT);
-- GB/T 16839.2-1997 Thermocouples - Part 2: Tolerances (IEC 60584-
2:1982+A1:1989, IDT);
-- GB 18282.1-2015 Sterilization of health care products - Chemical indicator - Part
1: General requirements (ISO 11140-1:2005, IDT).
This Part makes the following editorial changes:
-- Make some editorial modifications in accordance with the requirements of GB/T
1.1;
-- Delete Foreword of the international standard;
Sterilization of health care products - Chemical indicators -
Part 5: Class 2 indicators for Bowie and Dick-type air
removal tests
1 Scope
This Part of GB 18282 specifies the requirements for Class 2 indicators for Bowie and
Dick-type air removal tests used to evaluate the effectiveness of air removal during the
pre-vacuum phase of pre-vacuum steam sterilization cycles.
Additionally, this Part includes test methods and equipment used to meet these
performance requirements.
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition cited applies to this document. For
undated references, the latest edition (including any amendment) applies to this
document.
ISO 5-4:1995, Photography - Density measurements - Part 4: Geometric conditions
for reflection density
ISO 5636-3, Paper and board - Determination of air permeance (medium range) -
Part 3: Bendtsen method
ISO 11140-1:2005, Sterilization of health care products - Chemical indicators - Part
1: General requirements
IEC 60584-2:1982, Thermocouples - Part 2: Tolerances
IEC 60751:1983, Industrial platinum resistance thermometer sensors
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 11140-1 and
the following apply.
3.1 Indicator system
5.1.4 The indicator system shall have an air porosity not less than 1.7 μm/(Pa·s) when
tested in accordance with ISO 5636-3 at an air pressure of 1.47 kPa.
5.2 Performance
5.2.1 The indicator system shall show a uniform colour change (as specified by the
manufacturer) after exposure to saturated steam at 134°C for 3.5 min ± 5 s and/or
exposure to saturated steam at 121°C for 15 min ± 5 s, or such other combinations of
time and temperature as the manufacturer shall specify for the intended use of product.
In all cases, the permitted tolerance on the test temperature shall be +1.5 0 °C and the time
given shall be the time within which the colour change shall occur.
Compliance shall be tested in accordance with Appendix B.
5.2.2 When placed in the centre of the standard test pack as specified in Appendix E,
the indicator system shall show a non-uniform colour change when the temperature at
the centre of the standard test pack is 2+1 0 °C lower than the temperature of the chamber
drain at the beginning of the final 1 min of a 3.5 min cycle at 134°C, or at the beginning
of the final 5 min of a 15 min cycle at 121°C of the exposure phase of the steam
exposure apparatus. This is the standard fault condition generated by inadequate air
removal from the chamber. Any other combination of time and temperature stated by
the manufacturer shall exhibit a similar response at the beginning of the final 30% of
the exposure time.
Compliance shall be tested in accordance with Appendix F.
5.2.3 After exposure to dry heat at (140 ± 2)°C for not less than 30 min, the indicator
agent shall show either no change or a change that is markedly different from the change
occurring after exposure to a steam sterilization process.
Compliance shall be tested in accordance with Appendix C.
5.2.4 Transfer of the indicator agent to the material of the standard test pack in which it
is intended to be used shall not compromise the result of the test.
Compliance shall be tested in accordance with Appendix D.
Note: Although some transfer can be possible without adversely affecting the
performance of the indicator system or test pack, there are currently no test
methods available to verify the acceptable limits of indicator agent transfer.
5.2.5 The indicator system shall comply with the requirements of this Part for the
duration of the shelf life specified by the manufacturer.
A documented accelerated ageing procedure may be used in demonstrating compliance.