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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 45502-2-2:2008

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

    Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat ta...

    EN ISO 10993-6:2009

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

    Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

    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...

    EN ISO 11137-2:2015

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

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

    EN ISO 11135-1:2007

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

    Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a...

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