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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 ISO 26782:2009/AC:2009

    Medical devices Directive (93/42/EEC)

    Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 267...

    EN ISO 11737-1:2006

    Medical devices Directive (93/42/EEC)

    Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (...

    EN ISO 13485:2016/AC:2016

    Medical devices Directive (93/42/EEC)

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

    EN ISO 13485:2016

    Medical devices Directive (93/42/EEC)

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

    EN ISO 13408-7:2015

    Medical devices Directive (93/42/EEC)

    Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408...

    EN ISO 13408-6:2011

    Medical devices Directive (93/42/EEC)

    Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

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