ISO 8536-4:2007 医用输液器具 第4部分:一次性使用、重力输液式输液装置

标准编号:ISO 8536-4:2007

中文名称:医用输液器具 第4部分:一次性使用、重力输液式输液装置

英文名称:Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed

发布日期:2007-04

标准范围

ISO 8536-4:2007规定了医用一次性重力输液器的要求,以确保其与输液容器和静脉注射设备的兼容性。ISO 8536-4:2007的次要目的是提供有关输液器所用材料的质量和性能的规范指南,并给出输液器组件的名称。在一些国家,国家药典或其他国家法规具有法律约束力,优先于ISO 8536-4:2007。

ISO 8536-4:2007 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 8536-4:2007 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 8536-4:2007.

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