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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

    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 556-1:2001/AC:2006

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

    Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminal...

    EN ISO 14155:2011/AC:2011

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

    Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)

    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)

    EN ISO 13408-3:2011

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

    Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)

    EN ISO 13408-4:2011

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

    Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)

    EN ISO 10993-16:2017

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

    Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-...

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