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ISO 1135-4:2025

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

May 9, 2025

General information

60.60     May 9, 2025

ISO

ISO/TC 76

International Standard

11.040.20  

English   French  

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Published

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 1135-4:2015

NOW

PUBLISHED
ISO 1135-4:2025
60.60 Standard published
May 9, 2025

National adoptions

dnaSRPS EN ISO 1135-4:2022  
ISS

Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO/FDIS 1135-4:2025)

50.60   Close of voting. Proof returned by secretariat

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