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EN ISO 15747:2011 Standard

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  Keywords:

#plastic #international #parenterals #ml #standard

This standard is superseded by:
  •   EN ISO 15747:2019
  •   Directive

    Medical devices Directive (93/42/EEC)

      Last Official Journal reference

    Wednesday 14th of April 2021

      Description:

    Plastic containers for intravenous injections (ISO 15747:2010)

      Purpose

    This International Standard contains requirements that relate to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals. This International Standard is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions.

      Publication

    Friday 17th of November 2017

      Cessation

    This standard has been withdrawn on 2021-09-30

      Reference

    This standard supersedes the "EN ISO 15747:2010"

    Anyway is still possible use the "EN ISO 15747:2010" until April 30th, 2012

      Related Standards

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    Medical devices Directive (93/42/EEC)

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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.

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