EN ISO 80369-6 specifies requirements for small diameter connectors intended for use for connections in neural axis applications.
Neuraxial applications include the use of medical devices for administering drugs to neuraxial sites, administering wound infiltration anesthesia and other regional anesthetic procedures, or for monitoring or removing cerebrospinal fluid for therapeutic or diagnostic purposes.
Neuraxial sites of administration include the spine, the intrathecal or subarachnoid space, the ventricles of the brain, and the epi-, extra-, or peri-dural space. Neuraxial administration anesthetics can be applied locally, affecting a large part of the body, such as a limb, and include plexus blocks such as branchial plexus blocks or single nerve blocks. Neuraxial administration procedures involve continuous wound infusion with local anesthetic agents.
This part of EN ISO 80369 specifies dimensions and requirements for the design and functional performance of these through-hole connectors intended for use with medical devices.
This part of EN ISO 80369 does not specify requirements for medical devices or accessories that use these connectors. Such requirements are specifically given in International Standards for certain medical devices or accessories.
Manufacturers are encouraged to include the small diameter connectors specified in this part of EN ISO 80369 in medical devices, medical systems or accessories, even if they are not currently required by the relevant specific medical device standards. When the relevant specific medical device standards are revised, it is expected that requirements for small diameter connectors will be included as specified in this part of ISO 80369. It is also recognized that standards need to be developed for many medical devices used for neuraxial applications.
EN ISO 80369-1 specifies alternative methods of compliance with EN ISO 80369-80369 for small diameter connectors intended for use with neuraxial application medical devices or accessories that do not comply with this part of EN ISO 1.
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