ISO 80369-6:2016规定了用于轴向连接的小口径连接器的要求。神经轴的应用包括使用医疗设备，用于对神经轴部位进行药物治疗、伤口渗透麻醉输送和其他区域麻醉程序，或出于治疗或诊断目的监测或清除脑脊液。 注1:神经轴的应用部位包括脊柱、鞘内或蛛网膜下腔、脑室以及硬膜外、硬膜外或硬膜外腔。神经轴应用麻醉剂可局部施用，影响身体的大部分，如肢体，并包括神经丛阻滞，如鳃丛阻滞或单神经阻滞。 神经轴应用程序包括用局部麻醉剂持续灌注伤口。 注2:就ISO 80369本部分而言，皮下注射的局部麻醉不被视为神经轴麻醉。 预期给药的例子包括鞘内化疗、局部麻醉剂、放射性对比剂、抗生素、止痛药。 ISO 80369的本部分规定了医疗器械用小口径连接器的设计和功能性能的尺寸和要求。 ISO 80369的本部分未规定使用这些连接器的医疗设备或附件的要求。 这些要求在特定医疗设备或附件的特定国际标准中给出。 注3:鼓励制造商将ISO 80369本部分规定的小口径连接器纳入医疗设备、医疗系统或附件，即使相关特定医疗设备标准目前没有要求。预计修订相关特定医疗器械标准时，将包括ISO 80369本部分规定的小口径连接器要求。此外，人们认识到，许多用于神经轴应用的医疗设备需要制定标准。 注4 ISO 80369-1:2010第5.8节规定了符合ISO 80369-1:2010的替代方法，适用于不符合ISO 80369本部分要求的用于Neuraxic应用医疗设备或附件的小口径连接器。

ISO 80369-6:2016 specifies requirements for small-bore connectors intended to be used for connections in neuraxial applications. Neuraxial applications involve the use of medical devices intended to administer medications to neuraxial sites, wound infiltration anaesthesia delivery, and other regional anaesthesia procedures or to monitor or remove cerebro-spinal fluid for therapeutic or diagnostic purposes. NOTE 1 Sites for the neuraxial application include the spine, intrathecal or subarachnoid space, ventricles of the brain, and the epi-, extra-, or peri-dural space. Neuraxial application anaesthetics can be administered regionally affecting a large part of the body, such as a limb, and include plexus blocks, such as the branchial plexus blocks or single nerve blocks. Neuraxial application procedures include continuous infusion of wounds with local anaesthetic agents. NOTE 2 For the purposes of this part of ISO 80369, local anaesthesia injected hypodermically is not considered a neuraxial application. EXAMPLES Intended administration includes intrathecal chemotherapy, local anaesthetics, radiological contrast agents, antibiotics, analgesics. This part of ISO 80369 specifies dimensions and requirements for the design and functional performance of these small-bore connectors intended to be used with medical devices. This part of ISO 80369 does not specify 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. NOTE 3 Manufacturers are encouraged to incorporate the small-bore connectors specified in this part of ISO 80369 into medical devices, medical systems, 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 this part of ISO 80369, will be included. Furthermore, it is recognized that standards need to be developed for many medical devices used for neuraxial applications. NOTE 4 ISO 80369-1:2010, 5.8, specifies alternative methods of compliance with ISO 80369-1:2010, for small-bore connectors intended for use with neuraxial application medical devices or accessories, which do not comply with this part of ISO 80369.