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EN ISO 11137-1:2015 Standard

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  Keywords:

#devices #medical #process #sterilization #control

This standard can be totally or partially supervised by:
  •   EN ISO 11137-1:2015/A2:2019
  •   Directive

    Medical devices Regulation ((EU) 2017/745)

      Last Official Journal reference

    Thursday 11th of June 2026

      Description:

    Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)

      Purpose

    Amendment for EN ISO 11137-1:2015

      Publication

    Monday 19th of July 2021

      Related Standards

    EN ISO 13485:2016

    Medical devices Regulation ((EU) 2017/745)

    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

    EN ISO 11607-2:2020

    Medical devices Regulation ((EU) 2017/745)

    Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes ...

    EN ISO 10993-23:2021

    Medical devices Regulation ((EU) 2017/745)

    Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)

    EN ISO 10993-12:2021

    Medical devices Regulation ((EU) 2017/745)

    Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)

    EN ISO 10993-9:2021

    Medical devices Regulation ((EU) 2017/745)

    Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation produc...

    EN 285:2015+A1:2021

    Medical devices Regulation ((EU) 2017/745)

    Sterilization - Steam sterilizers - Large sterilizers

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