Need help?

EN ISO 11607-2:2006 Standard

wave
Save  

  Keywords:

#systems #packaging #barrier #sterile #include

This standard is superseded by:
  •   EN ISO 11607-2:2020
  •   This standard is no longer addressed in the last official Journal publication of the "2021-04-14 ". This standard is addressed for the last time in the official journal publication of the "2020-03-25"

      Directive

    Medical devices Directive (93/42/EEC)

      Last Official Journal reference

    Wednesday 25th of March 2020

      Description:

    Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)

      Purpose

    This part of ISO 11607 specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.

      Publication

    Friday 17th of November 2017

      Cessation

    This standard has been withdrawn on 2021-04-14

      Related Standards

    EN 1642:2011

    Medical devices Directive (93/42/EEC)

    Dentistry - Medical devices for dentistry - Dental implants

    EN 60601-1-2:2015

    Medical devices Directive (93/42/EEC)

    Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: El...

    EN 60601-2-20:2009

    Medical devices Directive (93/42/EEC)

    Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transpo...

    EN 60601-2-18:1996

    Medical devices Directive (93/42/EEC)

    Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipmentIEC 60601-2-18:1996

    EN 60601-2-13:2006/A1:2007

    Medical devices Directive (93/42/EEC)

    Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systemsI...

    EN 60601-2-13:2006

    Medical devices Directive (93/42/EEC)

    Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systemsI...

      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 11607-2:2006 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