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

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
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 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
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 temperature measured by all temperature sensors when immersed in a temperature source at a temperature known to within ± 0.1°C, and within the sterilization temperature band, shall not differ by more than 0.5°C.
e) The recording instrument shall record the temperature from a minimum of 6 sensors. The sampling interval shall not exceed 2.5 s. All data sampled shall be used for the interpretation of results.
f) The scale range shall include 0°C ~ 150°C. For analogue instruments, the minor mark interval shall not exceed 1°C, the resolution shall be not less than 0.5°C, and the chart speed shall be not less than 15 mm/min. Digital instruments shall register and record in increments of not more than 0.1°C.
g) The limit of error of the recording instrument between 0°C ~ 150°C (excluding temperature sensors) shall not exceed 0.25% when tested in an ambient temperature of (20 ± 3)°C. The additional error due to change in the environmental temperature shall not exceed 0.04%.
h) Calibration shall be carried out using a working or reference standard that is traceable to a national standard or a primary standard. The instrument shall have a valid test certificate.

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