GB 18282.3-2009Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (English PDF)

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 3 of GB 18282.

This Part equivalently adopts ISO 11140-3:2007 Sterilization of Health Care Products –

Chemical Indicators – Part 3: Class 2 Indicator Systems for Use in the Bowie and Dick-Type

Steam Penetration Test.

Compared with ISO 11140-3:2007, 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 ~ K of this Part are normative.

This Part was proposed by State 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; Beijing Medicare Jincheng Medical

Devices Co., Ltd.; and Shinva Medical Instrument Co., Ltd.

Chief drafters of this Part: Lu Wenjuan, Lu Zhong, Yuan Qin, Hu Xianghua, Lv Liansheng, and

Wan Jiuru.

Sterilization of Health Care Products – Chemical Indicators

– Part 3: Class 2 Indicator Systems for Use in the Bowie and

Dick-Type Steam Penetration Test

1 Scope

This Part of GB 18282 specifies the requirements for chemical indicators to be used in the

steam penetration test for steam sterilizers for wrapped goods, e.g., instruments and porous

materials. The indicator for this purpose is a Class 2 indicator as described in ISO 11140-1.

Indicators complying with this Part of GB 18282 are intended for use in combination with the

standard test pack as described in EN 285. This Part of GB 18282 does not consider the

performance of the standard test pack, but does specify the performance of the indicator systems.

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

for Reflection Density (ISO 5-4:1995, IDT)

ISO 187:1990 Paper, Board and Pulps -- Standard Atmosphere for Conditioning and

Testing and Procedure for Monitoring the Atmosphere and Conditioning of Samples

ISO 2248 Packaging - Complete, Filled Transport Packages - Vertical Impact Test by

Dropping

manufacturer.

Compliance shall be tested in accordance with Annex B.

f) It shall permit writing in permanent ink to be made legibly on both processed and

unprocessed materials. Markings made before processing shall be legible after

processing.

g) It shall be of size A4 in accordance with ISO 5457.

6 Performance Requirements