ISO 1135-4:2025

ISO 1135-4:2025

May 2025
International standard Current

Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed

This document specifies requirements for single use transfusion gravity sets for medical use to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment.It also provides guidance on specifications relating to the quality and performance of materials used in transfusion sets, presents designations for transfusion set components, and ensures 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.

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Main informations

Collections

International ISO standards

Publication date

May 2025

Number of pages

15 p.

Reference

ISO 1135-4:2025

ICS Codes

11.040.20   Transfusion, infusion and injection equipment

Print number

1
Sumary
Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed

This document specifies requirements for single use transfusion gravity sets for medical use to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment.

It also provides guidance on specifications relating to the quality and performance of materials used in transfusion sets, presents designations for transfusion set components, and ensures 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.

Replaced standards (1)
ISO 1135-4:2015
December 2015
International standard Cancelled
Transfusion equipment for medical use - Part 4 : transfusion sets for single use, gravity feed

ISO 1135-4:2015 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 ISO 1135-4:2015 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. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-4:2015.

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