标准摘要
[中文适用范围]： 本文件规定了用于医疗用途的一次性输血重力装置的要求，以确保其与血液和血液成分容器以及静脉输液设备的兼容性。文件还就输血装置所用材料的质量和性能相关规格提供指导，对输血装置的组件进行命名，并确保这些装置与多种细胞和血浆成分血液的兼容性。注：在某些国家，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 gravity sets for medical use to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment. It also provides guidance on specifications relating to the quality and performance of materials used in transfusion sets, presents designations for transfusion set components, and ensures the compatibility of sets with a range of cellular 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 4: Transfusion sets for single use, gravity feed