EN ISO 1135-4:2012

Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2012)

Publication date:   May 17, 2012

General information

99.60 Withdrawal effective   Dec 23, 2015

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.20   Transfusion, infusion and injection equipment

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Scope

ISO 1135-4:2011 specifies requirements for single-use transfusion sets for medical use in order to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment.
Secondary aims of ISO 1135-4:2011 are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets and to present designations for transfusion set components.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-4:2011.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 1135-4:2011

NOW

WITHDRAWN
EN ISO 1135-4:2012
99.60 Withdrawal effective
Dec 23, 2015

REVISED BY

PUBLISHED
EN ISO 1135-4:2015

PUBLISHED
EN ISO 1135-5:2015