DIN EN ISO 80369-6:2016-11

This standard has been prepared by Technical Committee ISO/TC 210 "Quality management and corresponding general aspects for medical devices" (secretariat: ANSI, USA) in collaboration with Technical Committee CEN/CLC/TC 3 "Quality management and corresponding general aspects for medical devices" (secretariat: NEN, Netherlands) with the participation of German experts. The responsible committee at DIN, the German Institute for Standardization e. V., is DIN Standards Committee Medicine (NAMed), Working Committee NA 063-01-11 AA "Kleinlumige Konnektoren für Flüssigkeiten und Gase zur Verwendung im Gesundheitsbereich" ("Small bore connectors for liquids and gases in health care applications"). 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. 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. For the purposes of this standard local anaesthesia injected hypodermically is not considered a neuraxial application. EXAMPLES Intended administration includes intrathecal chemotherapy, local anaesthetics, radiological contrast agents, antibiotics, analgesics. This 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.