ISO 80369-6 Scope
ISO 80369-6 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 or to monitor or remove cerebro-spinal fluid for therapeutic or diagnostic purposes. Sites for the Neuraxial applications include the intrathecal or subarachnoid space, ventricles of the brain and the epi-dural, extra-dural, or peri-dural space. Examples of the intended administration includes intrathecal chemotherapy, local anaesthetics, radiological contrast agents, antibiotics, analgesics.
ISO 80369-6 specifies dimensions and requirements for the design and functional performance of these small-bore connectors intended to be used with medical devices. 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.
ISO 80369-6 Reference Fittings
ISO 80369-6 Annex C specifies the Reference Fittings to be use to functionally test ISO 80369-6 neuraxial connectors. The testing methodology is defined in ISO 80369-20. We also offer extra-specification ISO 80369-6 Gages to test the physical attributes of the ISO 80369-6 Connectors.
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Original Posting: 8/25/2014
Last Revision: 7/22/2016
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