医疗应用中液体和气体的小直径连接器 第1部分：一般要求

[中文适用范围]： 本文件规定了用于向患者输送液体或气体的医疗设备或附件中，小口径连接器的一般接口要求。本文件还明确了这些小口径连接器的适用范围，包括但不限于以下情况：— 呼吸；— 肠道喂养；— 肢体袖带充气；— 神经；— 血管内或皮下注射；— 其他使用ISO 80369-7小口径连接器的应用场景。本文件提供了一种方法，用于基于小口径连接器本身的设计特性评估其非互连性特征，以减少因误连接而导致的风险，这些风险可能出现在医疗设备之间、不同应用附件之间，或者根据ISO和IEC 80369系列未来标准可能开发出的其他应用之间。注：A.2条款包含本条款的指导或理由。 [外文原描述]： This document specifies general interface requirements for small-bore connectors that form part of a medical device or accessory that conveys liquids or gases to a patient. This document also identifies the applications for which these small-bore connectors are intended to be used, which include, but are not limited to: - respiratory; - enteral; - limb cuff inflation; - neural; - intravascular or hypodermic; - other use cases utilizing an ISO 80369-7 small-bore connector. This document provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design in order to reduce the risk of misconnections between medical devices or between accessories for different applications as specified in this document as well as those that can be developed under future parts of the ISO and IEC 80369 series. NOTE Clause A.2 contains guidance or rationale for this Clause.