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.
Rationale
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.