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Content DescriptionThis 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 15Â kPa (e.g. a breathing system). The other connector (R2) is intended for use on medical devices and accessories subjected to higher pressures between 15Â kPa and 600Â kPa (e.g. oxygen therapy tubing). NOTEÂ 1Â Â Â Â Â Â Â The pressure is related to pressure available at the source to which the medical device is connected. NOTEÂ 2Â Â Â Â Â Â Â The intended application does not preclude the use of other connectors on medical devices or accessories within this application. NOTEÂ 3Â Â Â Â Â Â Â 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. NOTEÂ 4Â Â Â Â Â Â Â If a device-specific standard does not exist, the performance and material requirements specified in ISOÂ 80369-1 can be used as guidance. About ISOISO, the International Organization for Standardization, brings global experts together to agree on the best way of doing things – for anything from making a product to managing a process. As one of the oldest non-governmental international organizations, ISO has enabled trade and cooperation between people and companies all over the world since 1946. The International Standards published by ISO serve to make lives easier, safer and better. |
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