ISO 8536‑4:2010 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. Secondary aims of ISO 8536‑4:2010 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. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536‑4:2010.
ISO 8536‑4:2010 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.
Secondary aims of ISO 8536‑4:2010 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.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536‑4:2010.
Le présent document fixe les exigences relatives aux appareils de perfusion non réutilisables à usage médical, à alimentation par gravité, afin d'assurer leur compatibilité d'emploi avec les récipients pour préparations injectables et les dispositifs de ponctions veineuses. Il a également pour objectif de fournir des spécifications de qualité et de performance des matériaux utilisés dans les appareils de perfusion, et à présenter des désignations concernant les composants des appareils de perfusion. Il rentre dans le cadre de la directive nouvelle approche 93/42/CEE et constitue la partie 4 d'une série de normes présentées sous le titre général "Matériel de perfusion à usage médical". Dans certains pays, la pharmacopée nationale ou d'autres règlements nationaux ont force d'obligation et ont priorité sur le présent document.
<p>ISO 8536‑4:2010 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 ISO 8536‑4:2010 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 ISO 8536‑4:2010.</p>
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