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EN ISO 11607-1:2009 Standard

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  Keywords:

#systems #amendment #packaging #barrier #sterile

This standard is superseded by: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

      Cessation

    This standard has been withdrawn on 2021-04-14

      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 81060-2:2019

    Medical devices Directive (93/42/EEC)

    Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type (ISO 81060-2:2018)

    EN 1640:2009

    Medical devices Directive (93/42/EEC)

    Dentistry - Medical devices for dentistry - Equipment

    EN ISO 7396-1:2007

    Medical devices Directive (93/42/EEC)

    Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007)

    EN ISO 7197:2009

    Medical devices Directive (93/42/EEC)

    Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007)

    EN ISO 5840:2009

    Medical devices Directive (93/42/EEC)

    Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)

    EN ISO 5360:2009

    Medical devices Directive (93/42/EEC)

    Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2006)

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    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 11607-1:2009 STANDARD

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