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EVS-EN ISO 11737-1:2018+A1:2021

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018+ISO 11737-1:2018/Amd 1:2021)

General information
Valid from 01.07.2021
Base Documents
ISO 11737-1:2018; EN ISO 11737-1:2018; ISO 11737-1:2018/Amd 1:2021; EN ISO 11737-1:2018/A1:2021
Directives or regulations
None
Standard history
Status
Date
Type
Name
01.07.2021
Amendment
01.07.2021
Main + amendment
15.02.2018
Main

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.

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