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
This part of ISO 80369 specifies requirements for small-bore connectors intended to be used forconnections in neuraxial applications. Neuraxial applications involve the use of medical devicesintended to administer medications to neuraxial sites, wound infiltration anaesthesia delivery, andother regional anaesthesia procedures or to monitor or remove cerebro-spinal fluid for therapeutic ordiagnostic purposes.NOTE 1 Sites for the neuraxial application include the spine, intrathecal or subarachnoid space, ventriclesof the brain, and the epi-, extra-, or peri-dural space. Neuraxial application anaesthetics can be administeredregionally affecting a large part of the body, such as a limb, and include plexus blocks, such as the branchialplexus blocks or single nerve blocks. Neuraxial application procedures include continuous infusion of woundswith local anaesthetic agents.NOTE 2 For the purposes of this part of ISO 80369, local anaesthesia injected hypodermically is not considereda neuraxial application.EXAMPLES Intended administration includes intrathecal chemotherapy, local anaesthetics, radiologicalcontrast agents, antibiotics, analgesics.This part of ISO 80369 specifies dimensions and requirements for the design and functionalperformance 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 thatuse these connectors. Such requirements are given in particular International Standards for specificmedical devices or accessories.NOTE 3 Manufacturers are encouraged to incorporate the small-bore connectors specified in this part ofISO 80369 into medical devices, medical systems, or accessories, even if currently not required by the relevantparticular medical device standards. It is expected that when the relevant particular medical device standardsare 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 neuraxialapplications.NOTE 4 ISO 80369-1:2010, 5.8, specifies alternative methods of compliance with ISO 80369-1:2010, for smallboreconnectors intended for use with neuraxial application medical devices or accessories, which do notcomply with this part of ISO 80369.
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