La présente norme décrit les nécessaires pour perfusion 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 et elle est en accord avec le Guide du GPEM/SL à l'usage des acheteurs publics.
<p>ISO 8536-4:2004 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.</p> <p>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.</p> <p>In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.</p>
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