GB/T 19973.1-2023: Sterilization of health care products--Microbiological methods - Part 1: Determination of a population of microorganisms on products

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Scope

This Document specifies requirements and provides guidance on the enumeration and microbial
characterization of the population of viable microorganisms on or in a health care product,
component, raw material or package.
NOTE 1.The nature and extent of microbial characterization is dependent on the intended use of
bioburden data.
NOTE 2.See Annex A for guidance on Clauses 1 to 9.
This document does not apply to the enumeration or identification of viral, prion or protozoan
contaminants. This includes the removal and detection of the causative agents of spongiform
encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob
disease.
NOTE 3.Guidance on inactivating viruses and prions can be found in ISO 22442-3, ICH Q5A(R1) and
ISO 13022.
This Document does not apply to the microbiological monitoring of the environment in which
health care products are manufactured.

Basic Data

Standard ID	GB/T 19973.1-2023 (GB/T19973.1-2023)
Description (Translated English)	Sterilization of health care products--Microbiological methods - Part 1: Determination of a population of microorganisms on products
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C47
Classification of International Standard	11.080.01
Word Count Estimation	48,465
Date of Issue	2023-03-17
Date of Implementation	2024-10-01
Older Standard (superseded by this standard)	GB/T 19973.1-2015
Issuing agency(ies)	State Administration for Market Regulation, China National Standardization Administration