Need help?

EN ISO 15747:2011 Standard

wave
Save  

  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This standard is superseded by: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    This standard has been withdrawn on 2021-09-30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

    EN 60601-2-40:1998

    Medical devices Directive (93/42/EEC)

    Medical electrical equipment - Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment...

    EN 12183:2009

    Medical devices Directive (93/42/EEC)

    Manual wheelchairs - Requirements and test methods

    EN 14561:2006

    Medical devices Directive (93/42/EEC)

    Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of bactericidal activity for instruments use...

    EN ISO 14408:2009

    Medical devices Directive (93/42/EEC)

    Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2005)

    EN 14139:2010

    Medical devices Directive (93/42/EEC)

    Ophthalmic optics - Specifications for ready-to-wear spectacles

    EN 14079:2003

    Medical devices Directive (93/42/EEC)

    Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose...

      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 15747:2011 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