GB/T 19973.2-2018: Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

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Scope

This Part of GB/T 19973 specifies the general criteria for tests of sterility on
medical devices that have been exposed to a treatment with the sterilizing
agent reduced relative to that anticipated to be used in routine sterilization
processing. These tests are intended to be performed when defining, validating
or maintaining a sterilization process.
This Part is not applicable to:
a) sterility testing for routine release of product that has been subjected to a
sterilization process;
b) performing a test for sterility (see 3.12);
Note 1: The performance of a) or b) is not a requirement of ISO 11135-1, ISO 11137-1,
ISO 14160, ISO 14937 or ISO 17665-1.
c) culturing of biological indicators or inoculated products.
Note 2: Guidance on culturing biological indicators is included in ISO 14161.

Basic Data

Standard ID	GB/T 19973.2-2018 (GB/T19973.2-2018)
Description (Translated English)	Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C47
Classification of International Standard	11.080.01
Word Count Estimation	18,190
Date of Issue	2018-03-15
Date of Implementation	2019-04-01
Issuing agency(ies)	State Administration for Market Regulation, China National Standardization Administration