Transfusion equipment for medical use — Part 4: Transfusion sets for single use, gravity feed
医疗输液设备 - 第4部分:单次输血输液 重力喂料
发布日期:
2015-11-30
ISO 1135-4:2015规定了医用一次性输液重力装置的要求,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 1135-4:2015的次要目的是提供有关输血器所用材料的质量和性能的规范指南,提供输血器组件的名称,并确保输血器与一系列细胞和血浆血液组件的兼容性。
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-
4:2015.
ISO 1135-4:2015 specifies requirements for single use transfusion gravity 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 1135-4:2015 are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets, to present designations for transfusion set components, and to ensure the compatibility of sets with a range of cellular and plasma blood components.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-4:2015.