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EN ISO 11737-1:2018 Standard

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  Keywords:

#eu #main #regulation #products #safety

This standard can be totally or partially supervised by:
  •   EN ISO 11737-1:2018/A1:2021
  •   Directive

    Medical devices Regulation ((EU) 2017/745)

      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

    Wednesday 5th of January 2022

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