本文件规定了用于将血管内输液器连接到血管内输液器的连接器的设计和功能性能的接口尺寸和要求。 本文件未规定使用这些连接器的医疗设备或附件的尺寸和要求。这些要求在特定医疗设备或附件的特定国际标准中给出。 可能使用血管内储液罐连接器的医疗设备示例如下: -IV储液罐上的给药口和IV给药/血管内输液器/管线的配套尖峰，例如，IV袋/容器和IV装置的尖峰入口端； -拟在静脉输液器的给药口和静脉给药/给药管线的配合尖峰之间串联连接的装置； -使用鲁尔连接器的注射器和注射器IV套件。 以下连接器不在本文件范围内: -ISO 8536-2中规定的瓶塞； -IV贮存器和预期配套装置上的混合/混合端口。 示例:用于注射到储液罐中的橡胶塞和配套的药物混合装置（注射器、针头、重组装置以及用于进入混合或混合端口的其他辅助设备）。 -非动力（即弹性体）泵的加注口。 注1:为便于参考，附录G中提供了常用替代尖峰的详细信息。 注2:鼓励制造商将本文件中规定的连接器纳入血管内输液医疗设备或附件，即使特定医疗设备标准目前没有要求。 预计在修订特定医疗器械标准时，将包括ISO 18250中规定的储液罐连接器要求。

This document specifies the interface dimensions and requirements for the design and functional performance of connectors intended to be used to connect intravascular infusion sets to intravascular infusion reservoirs. 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. EXAMPLES Medical devices which may use intravascular reservoir connectors are the following: — Administration ports on IV fluid reservoirs and the mating spikes of IV administration/intravascular infusion sets/lines, e.g., IV bags/containers and the spike inlet ends of IV sets; — Devices intended to be connected in series between the administration port of IV fluid reservoirs and the mating spikes of IV administration/giving lines; — Syringes and syringe IV sets utilizing Luer connectors. The following connectors are excluded from the scope of this document: — Stoppers for bottles as specified in ISO 8536-2; — Compounding/admixture ports on IV reservoirs and intended mating devices. EXAMPLES Rubber stoppers used for injection into the reservoir and the mating pharmacy admixture devices (syringes, needles, reconstitution devices, and other ancillary equipment used to access the compounding or admixture ports). — The fill ports of non-powered (i.e. elastomeric) pumps. NOTE 1 Details of alternative spikes that are in common use are located in Annex G for informational purposes. NOTE 2 Manufacturers are encouraged to incorporate the connectors specified in this document into intravascular infusion medical 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 reservoir connectors, as specified in ISO 18250, will be included.