Need help?

EN ISO 10993-1:2009 Standard

wave
Save  

  Keywords:

#corrigendum #process #management #risk #testing

This standard can be totally or partially supervised by:
  •   EN ISO 10993-1:2009/AC:2010
  •   Directive

    Active implantable medical devices Directive (90/385/EEC)

      Last Official Journal reference

    Wednesday 14th of April 2021

      Description:

    Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

      Purpose

    Corrigendum to EN ISO 10993-1:2009.

      Publication

    Friday 17th of November 2017

      Related Standards

    EN ISO 10993-1:2009/AC:2010

    Active implantable medical devices Directive (90/385/EEC)

    Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

    EN 556-1:2001

    Active implantable medical devices Directive (90/385/EEC)

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

    EN ISO 13408-4:2011

    Active implantable medical devices Directive (90/385/EEC)

    Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)

    EN ISO 13408-3:2011

    Active implantable medical devices Directive (90/385/EEC)

    Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)

    EN ISO 13408-1:2015

    Active implantable medical devices Directive (90/385/EEC)

    Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

    EN ISO 11737-2:2009

    Active implantable medical devices Directive (90/385/EEC)

    Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation an...

      Stay up to date

      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