scope:

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 in neural applications. Neural applications involve the use of medical devices intended to administer medications to neural sites, wound infiltration anaesthesia delivery, and other regional anaesthesia procedures 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 the brain, and the epi-, extra-, or peri-dural space. Neural application anaesthetics can be administered regionally affecting a large part of the body, such as a limb, and include plexus blocks, such as the brachial plexus blocks or single nerve blocks. Neural application procedures include continuous infusion of wounds with local anaesthetic agents.

NOTE 3 For the purposes of this document, local anaesthesia injected hypodermically is not considered a neural application.

EXAMPLES Intended administration includes intrathecal chemotherapy, local anaesthetics, radiological contrast agents, antibiotics, analgesics.

This document does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular documents for specific medical devices or accessories.