UNE-EN ISO 80369-6:2016

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 1Sites 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 2For the purposes of this standard, local anaesthesia injected hypodermically is not considered a neuraxial APPLICATION.EXAMPLESIntended administration includes intrathecal chemotherapy, local anaesthetics, radiological contrast agents, antibiotics, analgesicsThis 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 3MANUFACTURERS 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 recognised that standards need to be developed for many MEDICAL DEVICES used for neuraxial APPLICATIONS.