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EN ISO 1135-4:2011

Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2010) EN ISO 1135-4:2011

Publication date:   Feb 17, 2012

General information

99.60 Withdrawal effective   Mar 7, 2012

CEN

CEN/TC 205 Non-active medical devices

European Norm

11.040.20   Transfusion, infusion and injection equipment

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Scope

ISO 1135-4:2010 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 1135-4:2010 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 1135-4:2010.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting
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Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 1135-4:2010

NOW

WITHDRAWN
EN ISO 1135-4:2011
99.60 Withdrawal effective
Mar 7, 2012

REVISED BY

WITHDRAWN
EN ISO 1135-4:2012

Relations

Adopted from ISO 1135-4:2010 IDENTICAL