医疗器械.医疗保健用贮存器输送系统连接器.第8部分:单采应用的柠檬酸盐抗凝溶液

[中文适用范围]： 本文件规定了血液成分分离装置用抗凝剂（AC）reservoir连接器的设计和功能性能的尺寸和要求。本文件未规定使用这些连接器的医疗器械或附件的尺寸和要求。特定国际标准中为具体医疗设备或附件提供了此类要求。本文件所述示例包括但不限于：——含有基于枸橼酸抗凝剂溶液的血液成分分离管路组及配套 reservoir。——血液成分分离管路组可用于血液采集、治疗应用和血浆采集。一些血液成分分离组是与已预连接的含枸橼酸抗凝剂溶液的 reservoir 组装在一起的。这些医疗器械不打算使用本文件规定的连接器。注意：鼓励制造商将本文件中所述的连接器纳入血液成分分离装置或附件，即使特定医疗设备标准未要求这样做。预期当特定医疗设备标准修订时，将包括对血液成分分离 AC reservoir 连接器的要求。 [外文原描述]： This document specifies dimensions and requirements for the design and functional performance of apheresis anticoagulant (AC) reservoir connectors. This document does not specify the dimensions and requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular International Standards for specific medical devices or accessories. The following examples of medical devices are intended to use the connectors of this document: — Apheresis tubing sets and mating reservoirs containing citrate-based anticoagulant solution. — Apheresis tubing sets may include, but are not limited to those for use in blood collection, therapeutic applications, and plasma collection. Some apheresis sets are manufactured with a pre-connected reservoir containing citrate-based anticoagulant solution. These medical devices are not intended to use the connectors of this document. NOTE Manufacturers are encouraged to incorporate the connectors specified in this document into apheresis devices or accessories, even if not currently required by the particular medical device standards. It is expected that when the particular medical device standards are revised, requirements for apheresis AC reservoir connectors, will be included.