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EN ISO 1135-4:2011 Standard

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  Keywords:

#part #transfusion #national #components #blood

  This standard is no longer addressed in the last official Journal publication of the "2022-01-05 ". This standard is addressed for the last time in the official journal publication of the "2022-01-05"

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 5th of January 2022

  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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