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This standard is superseded by: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
  •   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 ISO 13485:2016/AC:2018

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

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

    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 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 556-1:2001/AC:2006

    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 556-2:2015

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

    Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptic...

    EN ISO 10993-5:2009

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

    Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

      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