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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 ISO 10993-18:2009

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

    Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)

    EN ISO 10993-12:2012

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

    Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)

    EN 62304:2006/AC:2008

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

    Medical device software - Software life-cycle processesIEC 62304:2006

    EN ISO 11140-1:2009

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

    Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)

    EN ISO 11138-3:2009

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

    Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization process...

    EN ISO 11138-2:2009

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

    Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization pro...

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