Final Draft
International Standard
ISO/FDIS 1135-4
Transfusion equipment for medical use — Part 4: Transfusion sets for single use, gravity feed
Reference number
ISO/FDIS 1135-4
Edition 7
© ISO 2024
Final Draft International Standard
Under development
This draft is in the approval phase.
Will replace ISO 1135-4:2015

Abstract

This document specifies requirements for single use transfusion gravity 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 document are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets, to present designations for transfusion set components, and to ensure the compatibility of sets with a range of cellular and plasma blood components.

Note: In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this document.

General information

  • Status
     : Under development
    Stage
    : Final text received or FDIS registered for formal approval [50.00]
  • Edition
     : 7
  • Technical Committee :
    ISO/TC 76
    ICS :
    11.040.20 
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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