小口径连接器用于医疗应用中的液体和气体 第7部分：用于血管内或皮下应用的连接器（ISO 80369-7:2021 IDT）

[中文适用范围]： ，为制造商、使用者及监管机构提供了统一的技术依据。标准中还包含了与国际标准的一致性声明，确保技术要求的协调性和可追溯性。 ***此介绍可能不准确，请注意参考原文。 [外文原描述]： 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.