卫生保健设施中液体和气体用小口径连接器. 第3部分: 肠内应用连接器

[中文适用范围]： 本部分规定了小外径连接器的设计和功能性能的尺寸和要求，这些连接器用于医疗设备及其附件上的连接。NOTE1：涉及肠内给药系统的医疗器械包括肠内营养输液装置、肠引流装置、肠注射器及患者接口装置，包括访问端口。本部分不适用于使用这些连接器的医疗设备或其附件的要求。特定国际标准会给出具体医疗器械或附件的要求。本部分未规定下列小外径连接器的要求：仅用于胃吸作用的医疗设备；仅用于口腔给药的医疗设备（例如：仅用于向患者口腔直接给药，不连接其他医疗设备的注射器）；加压和减压用于保持侵入性肠内医疗器械固定的保留机制（如气球）；直肠引流、药物或液体灌注以及任何其他直肠接入医疗器械；胃肠道内窥镜设备；皮肤水平胃造口术医疗器械。NOTE2：鼓励制造商将本部分规定的连接器纳入肠内医疗设备或附件中，即使当前特定医疗设备标准并未要求这样做。预计在相关特定医疗设备标准修订时，将包含ISO 80369所规定的连接器要求。 [外文原描述]： 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.