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. 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.

Begin

2021-11-01

WI

00205370

Planned document number

DIN EN ISO 1135-4

Project number

06302113

Responsible national committee

NA 176-04-03 AA - Transfusion/infusion containers and equipment made from plastics and disposable sample containers for the in-vitro diagnostics  

Responsible european committee

CEN/TC 205 - Non-active medical devices  

Responsible international committee

ISO/TC 76/WG 1 - Soft containers for blood, blood components and parenterals; Infusion, transfusion and blood processing equipment  

draft standard

Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO/DIS 1135-4:2023); German and English version prEN ISO 1135-4:2023
2023-11
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previous edition(s)

Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2015); German version EN ISO 1135-4:2015
2016-06

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