ISO 80369-6:2016 卫生保健应用中液体和气体用小口径连接器 第6部分：椎管内应用的连接器

标准编号：ISO 80369-6:2016

中文名称：卫生保健应用中液体和气体用小口径连接器 第6部分：椎管内应用的连接器

英文名称：Small bore connectors for liquids and gases in healthcare applications — Part 6: Connectors for neuraxial applications

发布日期：2016-03

标准范围

ISO 80369-6:20 16规定了用于神经轴应用中连接的小孔连接器的要求。神经轴应用包括使用旨在向神经轴部位施用药物、伤口浸润麻醉递送和其他区域麻醉程序或出于治疗或诊断目的监测或去除脑脊液的医疗设备。注1神经轴应用的部位包括脊柱、鞘内或蛛网膜下腔、脑室以及硬膜外、硬膜外或周围腔。神经轴应用麻醉剂可以局部施用，影响身体的大部分，例如肢体，并且包括丛阻滞，例如分支丛阻滞或单神经阻滞。神经轴应用程序包括用局部麻醉剂连续输注伤口。注2:就ISO 80369本部分而言，皮下注射局部麻醉不被视为神经轴应用。预期施用的实例包括鞘内化学疗法、局部麻醉剂、放射造影剂、抗生素、止痛剂。ISO 80369的这一部分规定了用于医疗器械的这些小口径连接器的设计和功能性能的尺寸和要求。ISO 80369的这一部分没有规定使用这些连接器的医疗器械或附件的要求。这些要求在特定医疗器械或附件的国际标准中特别给出。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器械、医疗系统或附件中，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本部分中规定的小口径连接器的要求。此外，认识到需要为用于神经轴应用的许多医疗设备开发标准。注4 ISO 80369-1:20 10，5.8规定了符合ISO 80369-1:20 10的替代方法，适用于不符合ISO 80369本部分的神经轴应用医疗器械或附件。

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.

标准预览图