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EN ISO 8536-4:2007

Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2007)

Publication date:   Dec 20, 2008

General information

99.60 Withdrawal effective   Oct 1, 2010

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.20   Transfusion, infusion and injection equipment

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Scope

This part of ISO 8536 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 this part of ISO 8536 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 this part of ISO 8536.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting
Legislation 93/42/EEC

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 8536-4:2004

NOW

WITHDRAWN
EN ISO 8536-4:2007
99.60 Withdrawal effective
Oct 1, 2010

REVISED BY

WITHDRAWN
EN ISO 8536-4:2010