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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

    Medical devices Directive (93/42/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 62304:2006

    Medical devices Directive (93/42/EEC)

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

    EN ISO 10993-11:2009

    Medical devices Directive (93/42/EEC)

    Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)

    EN ISO 10993-3:2014

    Medical devices Directive (93/42/EEC)

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

    EN ISO 10993-4:2009

    Medical devices Directive (93/42/EEC)

    Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd...

    EN ISO 10993-5:2009

    Medical devices Directive (93/42/EEC)

    Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

    EN ISO 10993-6:2009

    Medical devices Directive (93/42/EEC)

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

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