标准摘要
[中文适用范围]： 本文件规定了适用于能够产生压力的加压输注设备使用的单次使用输血装置的要求。它确保了输血装置与血液及血液成分容器以及静脉输注设备的兼容性。本文件还提供了有关输血装置所用材料的质量和性能规格的指导，给出了输血装置组件的命名方法，并确保输血装置与红细胞和血浆成分的兼容性。注：在一些国家，国家药典或其他国家法规具有法律约束力，并优先于本文件。 [外文原描述]： This document specifies requirements for single use transfusion sets for use with pressure infusion equipment capable of generating pressures. It ensures compatibility with containers for blood and blood components as well as intravenous equipment. This document also provides 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. NOTE In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this document.
英文名称Transfusion equipment for medical use — Part 5: Transfusion sets for single use with pressure infusion apparatus