GB 18282.4-2009 English PDF (GB18282.4-2009)

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GB 18282.4-2009: Sterilization of health care products -- Chemical indicators -- Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
GB 18282.4-2009
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.080.01
C 47
GB 18282.4-2009 / ISO 11140-4:2007
Sterilization of Health Care Products – Chemical Indicators
– Part 4: Class 2 Indicators as an Alternative to the Bowie
and Dick-Type Test for Detection of Steam Penetration
(ISO 11140-4:2007, IDT)
ISSUED ON: NOVEMBER 15, 2009
IMPLEMENTED ON: DECEMBER 01, 2010
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 ... 4
1 Scope ... 6
2 Normative References ... 6
3 Terms and Definitions ... 7
4 General Requirements ... 8
5 Indicator System Format ... 10
6 Performance Requirements ... 10
7 Packaging and Labelling ... 12
8 Quality Assurance ... 14
Annex A (Normative) Determination of Indicator Strength during and after Steam
Sterilization ... 15
Annex B (Normative) Standard Test Cycles ... 17
Annex C (Normative) Estimation of Visual Difference Between Color of the Substrate
and of the Changed or Unchanged Indicator System by Determination of Relative
Reflectance Density ... 23
Annex D (Normative) Determination of Uniform Color Change on Exposure to
Saturated Steam ... 27
Annex E (Normative) Determination of Equivalence of the Alternative Indicator to the
Bowie and Dick Test ... 28
Annex F (Normative) Determination of Reproducibility of Fail Conditions Created in
a Standard Test Pack by Air Injection, Air Leak and Retained Air Systems ... 30
Annex G (Normative) Determination of Indicator Color Change on Exposure to Dry
Heat ... 34
Annex H (Normative) Determination of Shelf Life of Product ... 35
Annex I (Normative) Accelerated Ageing of Test Samples ... 36
Annex J (Normative) Steam exposure Apparatus and Steam for Test Purposes ... 37
Annex K (Normative) Standard Test Pack ... 40
Annex L (Normative) Air Injection System ... 41
Bibliography ... 43
Foreword
All the technical contents in this Part are mandatory.
GB 18282 Sterilization of Health Care Products – Chemical Indicators consists of the following
parts:
--- Part 1: General;
--- 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.
This Part is Part 4 of GB 18282.
This Part equivalently adopts ISO 11140-4:2007 Sterilization of Health Care Products –
Chemical Indicators – Part 3: Class 2 Indicators as an Alternative to the Bowie and Dick-Type
Test for Detection of Steam Penetration.
Compared with ISO 11140-4:2007, the major differences with this Part are as follows:
--- Make the editorial modifications as per the requirements in GB/T 1.1;
--- Delete the Foreword of the international standard;
--- For other international standards cited in this Part, if they have been converted into
Chinese standards, this Part will replace the referenced international standard number
with the corresponding national standard number, and indicate the adoption relationship.
The Annexes A ~ L of this Part are normative.
This Part was proposed by China Food and Drug Administration.
This Part shall be under the jurisdiction of National Technical Committee on Disinfection
Technology and Equipment of Standardization Administration of China (SAC/TC 200).
Drafting organizations of this Part: Guangzhou Medical Device Quality Supervision and
Inspection Center of State Food and Drug Administration; and Shinva Medical Instrument Co.,
Ltd.; and 3M China Ltd.
Chief drafters of this Part: Hu Xianghua, Huang Hongxin, Yuan Qin, Lu Wenjuan, He Xiaofan,
Wang Jiuru, and Huang Jingxiong.
Sterilization of Health Care Products – Chemical Indicators
– Part 4: Class 2 Indicators as an Alternative to the Bowie
and Dick-Type Test for Detection of Steam Penetration
1 Scope
This Part of GB 18282 specifies the performance for a Class 2 indicator to be used as an
alternative to the Bowie and Dick-type test for steam sterilizers for wrapped health care goods
(instruments, etc., and porous loads).
NOTE: The Bowie and Dick-type test is used for routine testing of steam sterilizers and validation of
steam sterilization processes.
An indicator complying with this Part of GB 18282 incorporates a specified material which is
used as a test load. This test load may, or may not, be re-usable. This Part of GB 18282 does
not specify requirements for the test load, but specifies the performance of the indicator in
combination with the test load with which it is intended to be used. The indicator specified in
this Part of GB 18282 is intended to identify poor steam penetration but does not necessarily
indicate the cause of this poor steam penetration.
This Part does not include test methods to establish the suitability of these indicator systems for
use in sterilizers in which the air removal stage does not include evacuation below atmospheric
pressure.
2 Normative References
The provisions in following documents become the provisions of this Part through reference in
this Part of GB 18282. For dated references, the subsequent amendments (excluding
corrigendum) or revisions do not apply to this Standard, however, parties who reach an
agreement based on this Standard are encouraged to study if the latest versions of these
documents are applicable. For undated references, the latest edition of the referenced document
applies.
GB/T 11501 Photography - Density Measurement - Part 3: Spectral Conditions (GB/T
11501-2008, ISO 5-3:1995, IDT)
GB/T 12823.1 Photography - Density Measurement - Part 1: Terms, Symbols and
Notations (GB/T 12823.1-2008, ISO 5-1:1984, IDT)
GB/T 12823.4-2008 Photography – Density Measurement - Part 4: Geometric Conditions
4.3 Compliance with the requirements of this Part of GB 18282 shall be determined by
establishing conformity with the performance requirements of Clause 6.
4.4 The indicator shall have sufficient strength to withstand steam sterilization and subsequent
handling. Compliance shall be tested in accordance with Annex A.
4.5 Test cycles for demonstrating compliance with the requirements of this Part of GB 18282
shall employ sub-atmospheric, trans-atmospheric and super-atmospheric air removal stages
(see Table 1 and Chapters B.1, B.2 and B.3) except when the indicator, or indicator system, is
intended solely for use with one type of air removal system, in which case only the specified
air removal system needs to be used during compliance testing.
4.6 A thermometric recording instrument(s) shall be used in conjunction with temperature
sensors to record the temperatures measured in the locations specified in the tests. The
temperature-measuring equipment used in all test methods for demonstrating compliance with
this Part of GB 18282 shall meet the following requirements.
a) Temperature sensors shall be either platinum resistance and comply with Class A of IEC
60751:1983 and its Amendment 1:1986 or a thermocouple and comply with one of the
tables of tolerance class 1 of GB/T 16839.2-1997.
b) The performance characteristic of the temperature sensor shall not be affected by the
environment in which it is used, e.g., pressure, steam or vacuum.
c) The temperature sensors shall have a response time in water of π90 ≤ 0.5 s.
d) The temperatur...