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EN ISO 11737-1:2018/A1:2021 Standard

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  Keywords:

#eu #main #regulation #products #safety

  Directive

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

  Last Official Journal reference

Wednesday 9th of October 2024

  Description:

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

  Purpose

ISO 11737-1 is a sterilization standard that specifies requirements and provides guidance on 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) 2017/745A — Relationship between EN ISO 11737-1 and the General Safety and Performance Requirements of Regulation (EU) 2017/746

  Publication

Friday 7th of January 2022

  Amendment

This standard is an amendment for "EN ISO 11737-1:2018"

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