Final Draft
International Standard
ISO/FDIS 1135-5
Transfusion equipment for medical use — Part 5: Transfusion sets for single use with pressure infusion apparatus
Reference number
ISO/FDIS 1135-5
Edition 2
Final Draft International Standard
ISO/FDIS 1135-5
83963
This draft is in the approval phase.
Will replace ISO 1135-5:2015

Abstract

This document specifies requirements for single use transfusion sets for use with pressure infusion equipment capable of generating pressures up to 200 kPa (2 bar). This International Standard ensures compatibility with containers for blood and blood components as well as 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 red cell and plasma blood components.

Platelet components should not be transfused under pressure using these sets.

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

General information

  •  : Under development
    : Final text received or FDIS registered for formal approval [50.00]
  •  : 2
  • ISO/TC 76
    11.040.20 
  • RSS updates

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

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