GB 18282.1-2015: Sterilization of health care products -- Chemical indicator -- Part 1: General requirements

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Scope

1.1 GB 18282 of the provisions of this part of the indicators - General requirements and test methods, these indicators are by physical and/or chemical substance
Matter changes to display its exposure to the sterilization process, and for monitoring to obtain predetermined single or multiple sterilization process parameters, they do not rely on micro
Biological survival or deactivation.
NOTE. The system relies on biological testing to prove the viability of the organism to be tested. About the class, the test system should be ISO 11138 series of biological means
It was shown (BIs) involved.
1.2 Requirements and Test Methods section GB 18282 applies to all other parts of the indicator stipulated, among other parts of the modified or increased
Canadian requirements, the specific requirements of Part This situation will apply.
Associated test equipment described in ISO 18472.
Note. The specific test indicators (II) Additional requirements GB 18282.3, GB 18282.4 and GB 18282.5 given in.

Basic Data

Standard ID	GB 18282.1-2015 (GB18282.1-2015)
Description (Translated English)	Sterilization of health care products -- Chemical indicator -- Part 1: General requirements
Sector / Industry	National Standard
Classification of Chinese Standard	C47
Classification of International Standard	11.080.01
Word Count Estimation	16,115
Date of Issue	2015-12-10
Date of Implementation	2017-01-01
Older Standard (superseded by this standard)	GB 18282.1-2000
Quoted Standard	GB/T 7408-2005; GB 18281; GB/T 19633.1-2015; GB/T 19633.2-2015; GB/T 24628-2009
Adopted Standard	ISO 11140-1-2005, IDT
Regulation (derived from)	National Standard Announcement 2015 No.38
Issuing agency(ies)	General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary	This standard specifies the general requirements for indicator and test methods, these indicators are by physical and/or chemical changes in the material to display its exposure to the sterilization process, and for monitoring obtained the required single or multiple sterilization process parameters, they do not depend on microorganism viability or deactivation. The requirements of the standard and test method is applicable to other parts of GB 18282 provisions of all indicators, in addition to other parts of the modified or added requirements, specific requirements will apply part of this case. Associated test equipment described in ISO 18472.