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ISO 1135-4:2010 Transfusion equipment for medical use - Part 4: Transfusion sets for single use
standard by International Organization for Standardization, 04/01/2010
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Full Description
ISO 11354:2010 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 11354:2010 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 11354:2010.