La présente norme décrit les nécessaires pour transfusion en précisant principalement les caractéristiques dimensionnelles et mécaniques du matériel considéré ainsi que les essais permettant de vérifier l'aptitude à l'emploi. La présente norme est complémentaire des monographies de la Pharmacopée française sur le sujet.
<p>ISO 1135-4:2004 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.</p> <p>ISO 1135-4:2004 also specifies requirements for air-inlet devices for use with rigid containers for blood and blood components.</p> <p>Secondary aims of ISO 1135-4:2004 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.</p> <p>In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-4:2004.</p>
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