UNE-EN ISO 80369-6:2026

NOTE 1 There is rationale for this requirement in Annex A, A.1.This document specifies requirements for small-bore connectors intended to be used for connections inneural applications. Neural applications involve the use of medical devices intended to administermedications to neural sites, wound infiltration anaesthesia delivery, and other regional anaesthesiaprocedures or to monitor or remove cerebro-spinal fluid for therapeutic or diagnostic purposes.NOTE 2 Sites for the neural application include the spine, intrathecal or subarachnoid space, ventricles of thebrain, and the epi-, extra-, or peri-dural space. Neural application anaesthetics can be administered regionallyaffecting a large part of the body, such as a limb, and include plexus blocks, such as the brachial plexus blocks orsingle nerve blocks. Neural application procedures include continuous infusion of wounds with local anaestheticagents.NOTE 3 For the purposes of this document, local anaesthesia injected hypodermically is not considered aneural application.EXAMPLES Intended administration includes intrathecal chemotherapy, local anaesthetics, radiologicalcontrast agents, antibiotics, analgesics.This document does not specify requirements for the medical devices or accessories that use theseconnectors. Such requirements are given in particular documents for specific medical devices oraccessories.