ISO 80369-7:2021 医疗保健用液体和气体用小口径连接器 第7部分：血管内或皮下应用连接器

标准编号：ISO 80369-7:2021

中文名称：医疗保健用液体和气体用小口径连接器 第7部分：血管内或皮下应用连接器

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：2021-05

标准范围

本文件规定了用于医疗器械和附件血管内应用中的连接或皮下应用中的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）插管，具有公和母鲁尔滑动连接器和鲁尔锁连接器。注1见附件A。注2鲁尔接头最初设计用于高达300 kPa的压力。本文件未规定使用这些连接器的医疗器械或附件的要求。此类要求在特定医疗器械或附件的特定文件中给出。本文件未规定以下小孔连接器的要求，这些要求在其他文件中规定:-血液透析器、血液透析滤器和血液滤器血液隔室端口(ISO 8637[5]和ISO 8638[6]中提及血液隔室端口的适用部分)；-血液透析、血液透析滤过和血液滤过设备连接器(ISO 8637[5])；-输注系统闭合穿刺连接器（ISO 8536-？4[4]）。注3鼓励制造商将本文件中规定的小口径连接器纳入医疗器械或附件中，即使相关特定医疗器械文件目前没有要求。预计在修订相关特定医疗器械文件时，将纳入ISO 80369中规定的小口径连接器要求。注4 ISO 80369-？1:20 18第7条规定了符合ISO 80369-？1:20 18，适用于不符合本文件的血管内应用或皮下注射医疗器械或附件的小口径连接器。

This document 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 See Annex A.
NOTE 2 The Luer connector was originally designed for use at pressures up to 300 kPa.
This document does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular documents for specific medical devices or accessories.
This document does not specify requirements for the following small-bore connectors, which are specified in other documents:
- haemodialyser, haemodiafilter and haemofilter blood compartment ports (ISO 8637 [5] and applicable portion of ISO 8638 [6] referencing blood compartment ports);
- haemodialysis, haemodiafiltration and haemofiltration equipment connectors (ISO 8637 [5]);
- infusion system closure piercing connectors (ISO 8536-？4 [4]).
NOTE 3 Manufacturers are encouraged to incorporate the small-bore connectors specified in this document into medical devices or accessories, even if currently not required by the relevant particular medical device documents. It is expected that when the relevant particular medical device documents are revised, requirements for small-bore connectors, as specified in ISO 80369, will be included.
NOTE 4 ISO 80369-？1:2018, Clause 7, specifies alternative methods of conformance with ISO 80369-？1:2018, for small-bore connectors intended for use with intravascular applications or hypodermic application medical devices or accessories, which do not conform with this document.

标准预览图