Need help?

EN ISO 11607-1:2009 Standard

wave
Save  

  Keywords:

#systems #amendment #packaging #barrier #sterile

This standard is superseded by:
  •   EN ISO 11607-1:2020
  •   EN ISO 11607-1:2020
  •   Directive

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

      Last Official Journal reference

    Wednesday 14th of April 2021

      Description:

    Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)

      Purpose

    Amendment for EN ISO 11607-1:2009.

      Publication

    Friday 17th of November 2017

      Reference

    This standard supersedes the "EN ISO 11607-1:2006"

    Anyway is still possible use the "EN ISO 11607-1:2006" until March 21st, 2010

      Related Standards

    EN 45502-2-3:2010

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

    Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems

    EN ISO 25424:2019

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

    Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and rout...

    EN 60601-1:2006/A1:2013

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

    Medical electrical equipment - Part 1: General requirements for basic safety and essential performanceIEC 60601-1:2005

    EN ISO 15223-1:2016

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

    Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requir...

    EN ISO 13485:2016

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

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

    EN ISO 13408-6:2011

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

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

      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