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EN ISO 11137-1:2015 Standard

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  Keywords:

#devices #medical #process #sterilization #control

This standard is superseded by: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

    Active implantable medical devices Directive (90/385/EEC)

      Last Official Journal reference

    Wednesday 14th of April 2021

      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

    Friday 17th of November 2017

      Reference

    This standard supersedes the "EN ISO 11137-1:2006"

    Anyway is still possible use the "EN ISO 11137-1:2006" until June 30th, 2016

      Related Standards

    EN ISO 11737-1:2006

    Active implantable medical devices Directive (90/385/EEC)

    Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (...

    EN ISO 14937:2009

    Active implantable medical devices Directive (90/385/EEC)

    Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, vali...

    EN ISO 11607-1:2009

    Active implantable medical devices Directive (90/385/EEC)

    Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging sy...

    EN ISO 11737-1:2006/AC:2009

    Active implantable medical devices Directive (90/385/EEC)

    Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (...

    EN ISO 11737-2:2009

    Active implantable medical devices Directive (90/385/EEC)

    Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation an...

    EN ISO 13408-1:2015

    Active implantable medical devices Directive (90/385/EEC)

    Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

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