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EN ISO 8536-12:2021

Infusion equipment for medical use - Part 12: Check valves for single use (ISO 8536-12:2021) EN ISO 8536-12:2021

Publication date:   Jun 15, 2021

General information

60.60 Standard published   Feb 17, 2021

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.20   Transfusion, infusion and injection equipment

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Scope

This document specifies requirements for check valves intended for single use and used with infusion equipment both with gravity-feed infusion and with pressure infusion apparatus.
The functional requirements in this document also apply to inline check valves.

Related legislation

Legislation related to this standard

2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

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Life cycle

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PUBLISHED
EN ISO 8536-12:2021
60.60 Standard published
Feb 17, 2021