Abstract

This document specifies requirements for single use transfusion sets for use with pressure infusion equipment capable of generating pressures. It ensures compatibility with containers for blood and blood components as well as intravenous equipment. The document also provides 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.

Begin

2021-11-01

WI

00205371

Planned document number

DIN EN ISO 1135-5

Project number

06302114

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 5: Transfusion sets for single use with pressure infusion apparatus (ISO/DIS 1135-5:2023); German and English version prEN ISO 1135-5:2023
2023-11
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previous edition(s)

Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2015); German version EN ISO 1135-5:2015
2016-06

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