ISO 80369-2:2024 医疗保健应用中液体和气体用小口径连接器 第2部分：呼吸应用连接器

标准编号：ISO 80369-2:2024

中文名称：医疗保健应用中液体和气体用小口径连接器 第2部分：呼吸应用连接器

英文名称：Small-bore connectors for liquids and gases in healthcare applications — Part 2: Connectors for respiratory applications

发布日期：2024-07

标准范围

本文件规定了用于医疗器械和附件呼吸应用连接的两个小口径连接器的设计和尺寸。一个连接器（R1）旨在用于承受高达15 kPa压力的医疗设备和附件（例如呼吸系统）。另一个连接器（R2）旨在用于承受15 kPa至600 kPa之间较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处的可用压力有关。注2预期应用不排除在本应用范围内医疗器械或附件上使用其他连接器。注3 ISO 80369-中规定了该预期应用中替代连接器的要求。1.本文件未规定使用这些连接器的医疗器械或附件的要求。此类要求在设备特定标准中给出。注4:如果不存在器械特定标准，则可以使用ISO 80369-1中规定的性能和材料要求作为指导。

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.

标准预览图