ISO 80369-3:2016规定了用于肠内医疗设备和附件连接的小口径连接器的设计和功能性能的尺寸和要求。 注1:肠内医疗设备包括肠内喂食设备、肠内引流设备、肠内注射器和患者接口设备，包括接入端口。 它没有规定使用这些连接器的医疗设备或附件的尺寸和要求。这些要求在特定医疗设备或附件的特定国际标准中给出。 它没有规定用于以下用途的小口径连接器的要求: -仅胃吸医疗器械； -仅限口服医疗器械； 示例:口腔针头注射器，不用于连接其他医疗设备。 其目的是直接给患者口腔注射。 -对用于固定侵入性肠道医疗器械的保持机构（如气囊）加压和降压； -直肠引流、药物或液体直肠给药的医疗设备，以及任何其他直肠通路医疗设备； -胃肠内窥镜设备； -皮肤水平胃造口医疗设备。 注2:鼓励制造商将ISO 80369-3:2016中规定的小口径连接器纳入肠道医疗器械或附件，即使相关特定医疗器械标准目前没有要求。预计在修订相关特定医疗器械标准时，将包括ISO 80369中规定的小口径连接器要求。

ISO 80369-3:2016 specifies the dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections on enteral medical devices and accessories. NOTE 1 Enteral medical devices include enteral feeding sets, enteral drainage sets, enteral syringes, and patient interface devices including access ports. It does not specify the dimensions and requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular International Standards for specific medical devices or accessories. It does not specify requirements for small-bore connectors that are used for the following: - gastric suction-only medical devices; - oral-only medical devices; EXAMPLE An oral tip syringe that is not intended to connect to another medical device. It is intended to administer directly to the patient's mouth. - pressurizing and depressurizing the retention mechanism (e.g. balloon) used to hold invasive enteral medical devices in place; - medical devices for rectal drainage, rectal administration of medicines or fluid, and any other rectal access medical device; - gastrointestinal endoscopy equipment; - skin level gastrostomy medical devices. NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in ISO 80369-3 :2016 into enteral medical devices or accessories, even if currently not required by the relevant particular medical device standards. It is expected that when the relevant particular medical device standards are revised, requirements for small-bore connectors, as specified in ISO 80369, will be included.