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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 5th of January 2022

      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 556-1:2001/AC:2006

    Medical devices Directive (93/42/EEC)

    Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminal...

    EN 60601-2-5:2000

    Medical devices Directive (93/42/EEC)

    Medical electrical equipment - Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipmentIEC 60601-2-5...

    EN 60601-1-8:2007/AC:2010

    Medical devices Directive (93/42/EEC)

    Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: Ge...

    EN 60601-1-8:2007/A11:2017

    Medical devices Directive (93/42/EEC)

    Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: Ge...

    EN 60601-1-10:2008

    Medical devices Directive (93/42/EEC)

    Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: R...

    EN 60601-1-11:2010

    Medical devices Directive (93/42/EEC)

    Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: R...

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    CELAB can accomplish all the required tests in order to affix the CE-marking related to EMC, LVD, RED, MDD, machines and many others.

    CLICK HERE TO GET TESTS AND INFO ON THE EN ISO 11137-1:2015 STANDARD

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