ISO 1135-4:2010 医用输血器具 第4部分:一次性使用输血器

标准编号:ISO 1135-4:2010

中文名称:医用输血器具 第4部分:一次性使用输血器

英文名称:Transfusion equipment for medical use — Part 4: Transfusion sets for single use

发布日期:2010-04

标准范围

ISO 1135?4:2010规定了医用一次性输液器的要求,以确保其与血液和血液成分容器以及静脉注射设备的兼容性。ISO 1135?4:2010的第二个目标是提供有关输血器所用材料的质量和性能的规范指南,并给出输血器组件的名称。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 1135?4:2010。

ISO 1135?4:2010 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 1135?4:2010 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 1135?4:2010.

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