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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 1641:2009

    Medical devices Directive (93/42/EEC)

    Dentistry - Medical devices for dentistry - Materials

    EN ISO 11137-2:2015

    Medical devices Directive (93/42/EEC)

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

    EN ISO 13408-2:2011

    Medical devices Directive (93/42/EEC)

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

    EN 60601-2-45:2001

    Medical devices Directive (93/42/EEC)

    Medical electrical equipment -- Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic...

    EN 13060:2014

    Medical devices Directive (93/42/EEC)

    Small steam sterilizers

    EN ISO 11990-1:2014

    Medical devices Directive (93/42/EEC)

    Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1: Tracheal tube shaft (ISO 11990-...

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