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EN ISO 1135-4:2011 Standard

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  Keywords:

#part #transfusion #national #components #blood

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2010)

  Purpose

This part of ISO 1135 specifies requirements for single-use transfusion sets for medical use in order to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment. Secondary aims of this part of ISO 1135 are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets and to present designations for transfusion set components. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 1135.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 1135-4:2010"

Anyway is still possible use the "EN ISO 1135-4:2010" until April 30th, 2012

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