医疗保健设施中液体与气体用小型孔连接器. 第6部分: 椎管内应用连接器

[中文适用范围]： 本部分适用于小口径连接器，用于神经轴应用中的连接。神经轴应用涉及用于神经轴部位给药、伤口浸润麻醉输送以及其他区域麻醉程序的医疗设备，以及用于监测或移除脑脊液以达到治疗或诊断目的。 注释1：神经轴应用的部位包括脊柱、腰池或蛛网膜下腔、脑室和硬膜内、外或周围间隙。 神经轴麻醉剂可以区域性地影响身体的大部，如肢体，并包括分支阻滞（如颈丛阻滞）或其他单一神经阻滞。神经轴程序包括使用局部麻醉剂进行的持续输注。 注释2：本部分不将皮下注射局部麻醉视为神经轴应用。 示例：给药意图包括腰椎化疗、局部麻醉剂、放射对比剂、抗生素和止痛药。 [外文原描述]： 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.