Need help?

EN ISO 11137-1:2015 Standard

wave
Save  

  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 60601-2-33:2010

    Medical devices Directive (93/42/EEC)

    Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic reson...

    EN ISO 10651-2:2009

    Medical devices Directive (93/42/EEC)

    Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilat...

    EN ISO 10079-1:2009

    Medical devices Directive (93/42/EEC)

    Medical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements (ISO 10079-1:1999)

    EN ISO 10079-2:2009

    Medical devices Directive (93/42/EEC)

    Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1999)

    EN ISO 10079-3:2009

    Medical devices Directive (93/42/EEC)

    Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source (ISO 10079-3:1999)

    EN ISO 10328:2016

    Medical devices Directive (93/42/EEC)

    Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016)

      Stay up to date

    CELAB is Notified Body No.2037 for the EMC Directive and Italian office of a Notified Body for the RED Directive.

    CELAB performs voluntary inspection activities on technical construction files to check their contents.

    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

      ACCESS

    Search for a standard
    GO

    Register

    Already a member?
    Login

      OTHER APPLICATIONS

    If you are interested in DO160 tests, you can give a try to our other free of charge software:
    CE-Marking assistant, Version: 1.3.0