医疗保健应用中用于液体和气体的小口径连接器 第2部分：呼吸应用连接器

[中文适用范围]： 本文件规定了两种小口径连接器的设计和尺寸，用于连接医疗器械和附件的呼吸应用。一个连接器（R1）用于承受高达 15 kPa 压力的医疗器械和附件（例如呼吸系统）。另一个连接器（R2）用于承受 15 kPa 至 600 kPa 之间更高压力的医疗器械和附件（例如氧气治疗管）。注 1 压力与医疗器械所连接的源头处的压力有关。注 2 预期应用并不排除在此应用范围内的医疗器械或附件上使用其他连接器。注 3 ISO 80369-1 中规定了此预期应用的替代连接器的要求。本文件未规定使用这些连接器的医疗器械或附件的要求。此类要求在特定于器械的标准中给出。注 4 如果不存在特定于器械的标准，则应遵循 ISO 80369-1 中规定的性能和材料要求 [外文原描述]： This document specifies the design and dimensions for two small-bore connectors intended to be used for connections in respiratory applications of medical devices and accessories. One connector (R1) is intended for use on medical devices and accessories subjected to pressures up to 15 kPa (e.g. a breathing system). The other connector (R2) is intended for use on medical devices and accessories subjected to higher pressures between 15 kPa and 600 kPa (e.g. oxygen therapy tubing). NOTE 1 The pressure is related to pressure available at the source to which the medical device is connected. NOTE 2 The intended application does not preclude the use of other connectors on medical devices or accessories within this application. NOTE 3 Requirements for alternative connectors for this intended application are specified in ISO 80369-1. This document does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in device-specific standards. NOTE 4 If a device-specific standard does not exist, the performance and material requirements specified in ISO 80369-1 can be used as guidance.