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

Scope

This document specifies the count and identification of microorganisms surviving on the surface or inside of medical healthcare products, components, raw materials, or packaging, and provides guidelines.
Note 1: The characteristics and extent of microorganism identification depend on the intended use of the bioburden data.
Note 2: Guidelines for Chapters 1 to 9 can be found in Appendix A.
The requirements specified in this document do not apply to the count or identification of viral, prion, or protozoan contaminants, including the collection and detection of pathogens for spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy (BSE), and Creutzfeldt-Jakob disease (CJD).
Note 3: ISO 224423, ICH Q5A (R1), and ISO 13022 provide applicable guidelines for inactivating viruses and prions.
This document does not apply to microbial monitoring in the production environment of medical healthcare products.

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