BS EN ISO 80369-6:2016

1   * Scope This part of ISO 80369 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](/search?q=ISO%C2%A080369), local anaesthesia injected hypodermically is not considered a neuraxial  application . 


    EXAMPLES  
   Intended ad...