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EN ISO 11137-1:2015 Standard

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  Keywords:

#requirements #part #specifies #sterilization #may

This standard is superseeded 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 25th of March 2020

      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

    This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. NOTE Although the scope of this part of ISO 11137 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment.

      Publication

    Friday 17th of November 2017

      Reference

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

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

      Related Standards

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

    Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:...

    EN ISO 13485:2016

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

    EN ISO 11737-1:2006/AC:2009

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    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)

    EN ISO 13408-2:2011

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

    Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)

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