ISO 80369-7:2016 卫生保健应用中液体和气体用小口径连接器 第7部分：血管内或皮下注射用连接器

标准编号：ISO 80369-7:2016

中文名称：卫生保健应用中液体和气体用小口径连接器 第7部分：血管内或皮下注射用连接器

英文名称：Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications

发布日期：2016-10

标准范围

ISO 80369-7:2016规定了用于医疗设备和附件的血管内连接或皮下连接的小口径连接器的设计和功能性能的尺寸和要求。示例:皮下注射器和针头或血管内（IV）套管，带有公、母鲁尔滑动连接器和鲁尔锁连接器。注1:鲁尔连接器最初设计用于300 kPa以下的压力。ISO 80369-7:2016未规定使用这些连接器的医疗设备或附件的要求。这些要求在特定医疗设备或附件的特定国际标准中给出。ISO 80369-7:2016未规定其他国际标准中规定的以下小口径连接器的要求:-血液透析器、血液透析过滤器和血液过滤器血液腔室端口（ISO 8637和ISO 8638中参考血液腔室端口的适用部分）；-血液透析、血液透析过滤和血液过滤设备连接器（ISO 8637）；-输液系统闭合穿孔连接器（ISO 8536-4）。注2:鼓励制造商采用小型-将ISO 80369本部分规定的连接器钻孔至医疗器械或附件，即使相关特定医疗器械标准目前没有要求。预计在修订相关特定医疗器械标准时，将包括ISO 80369中规定的小口径连接器要求。注3 ISO 80369-1:2010第5.8节规定了符合ISO 80369-1:2010的替代方法，适用于不符合ISO 80369本部分要求的用于血管内应用或皮下应用医疗设备或附件的小口径连接器。

ISO 80369-7:2016 specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories.EXAMPLES Hypodermic syringes and needles or intravascular (IV) cannulae with male and female luer slip connectors and luer lock connectors.NOTE 1 The luer connector was originally designed for use at pressures up to 300 kPa.ISO 80369-7:2016 does not specify 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.ISO 80369-7:2016 does not specify requirements for the following small-bore connectors, which are specified in other International Standards:- haemodialyser, haemodiafilter and haemofilter blood compartment ports (ISO 8637 and applicable portion of ISO 8638 referencing blood compartment ports);- haemodialysis, haemodiafiltration and haemofiltration equipment connectors (ISO 8637);- infusion system closure piercing connectors (ISO 8536？4).NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in this part of ISO 80369 into medical devices or accessories, even if currently not required by the relevant particular medical device standards. It is expected that when the relevant particular medical device standards are revised, requirements for small-bore connectors, as specified in ISO 80369, will be included.NOTE 3 ISO 80369？1:2010, 5.8, specifies alternative methods of compliance with ISO 80369？1:2010, for small-bore connectors intended for use with intravascular applications or hypodermic application medical devices or accessories, which do not comply with this part of ISO 80369.

标准预览图