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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 - Amendment 1 (ISO 11737-1:2018/Amd 1:2021)

General information

Valid from 01.07.2021
Base Documents
ISO 11737-1:2018/Amd 1:2021; EN ISO 11737-1:2018/A1:2021

Standard history

Status
Date
Type
Name
01.07.2021
Amendment
01.07.2021
Main + amendment
15.02.2018
Main
ISO 11737-1 is a sterilization standard that specifies requirements and guides the enumeration and microbial characterization of microorganisms on healthcare products. EN ISO 11737-1:2018/A1:2021 modifies the European standard EN ISO 11737-1:2018. The main text and the consolidated version which consists of the main text and the amendment can be found in the standard’s history.

In this amendment you can find:

— Relationship between EN ISO 11737-1 and the General Safety and Performance Requirements of Regulation (EU) 2017/745

— Relationship between EN ISO 11737-1 and the General Safety and Performance Requirements of Regulation (EU) 2017/746

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