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SSH EN ISO 8536-4:2013

Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2010)

Apr 23, 2014
95.99 Withdrawal of Standard   Jun 29, 2021

General information

95.99     Jun 29, 2021

DPS

DPS/KT 205

European Norm

11.040.20  

English  

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Scope

ISO 8536‑4:2010 specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment.
Secondary aims of ISO 8536‑4:2010 are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536‑4:2010.

Related directives

Directives related to this standards.

93/42/EEC

Medical devices

Life cycle

PREVIOUSLY

WITHDRAWN
SSH EN ISO 8536-4:2010

NOW

WITHDRAWN
SSH EN ISO 8536-4:2013
95.99 Withdrawal of Standard
Jun 29, 2021

REVISED BY

PUBLISHED
SSH EN ISO 8536-4:2020

Related project

Adopted from EN ISO 8536-4:2013