Transfusion equipment for medical use — Part 5: Transfusion sets for single use with pressure infusion apparatus
输血设备用于医疗用途 - 第5部分:输血装置一次性用于压力输液装置
发布日期:
2015-11-30
ISO 1135-5:2015规定了与能够产生200 kPa(2 bar)压力的压力输液设备一起使用的一次性输液器的要求。该国际标准确保了与血液和血液成分容器以及静脉注射设备的兼容性。
ISO 1135-5:2015的次要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,提供输血器组件的名称,并确保输血器与红细胞和血浆成分的兼容性。
血小板成分不应使用这些装置在压力下输注。
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 1135-5:2015。
ISO 1135-5:2015 specifies requirements for single use transfusion sets for use with pressure infusion equipment capable of generating pressures up to 200 kPa (2 bar). This International Standard ensures compatibility with containers for blood and blood components as well as intravenous equipment.
Secondary aims of ISO 1135-5:2015 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 red cell and plasma blood components.
Platelet components should not be transfused under pressure using these sets.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-5:2015.