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EN ISO 11737-1:2018 Standard

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  Keywords:

#products #regulation #eu #safety #main

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

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

      Last Official Journal reference

    Monday 15th of June 2026

      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 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

      Publication

    Friday 7th of January 2022

      Related Standards

    EN ISO 14971:2019/A11:2021

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

    Medical devices - Application of risk management to medical devices (ISO 14971:2019)

    EN ISO 11137-2:2015

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

    Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

    EN ISO 18113-5:2024

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    In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instrumen...

    EN ISO 18113-2:2024

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

    In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents ...

    EN ISO 11737-2:2020

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

    Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validati...

    EN ISO 13408-6:2021

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

    Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)

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