This document specifies general requirements and test methods for catheter systems intended to be used in neuraxial applications.
This document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate conformity with these requirements.
Catheters for neuraxial applications are intended to administer medications directly into neuraxial sites, to deliver wound infiltration analgesia and to other regional analgesia procedures or to monitor or remove fluids from neuraxial sites for therapeutic or diagnostic purposes.
NOTE 1 Sites for the neuraxial application include the spine, intrathecal or subarachnoid space and the epi-, extra-, or peri-dural space (applications mentioned are just examples and not an exhaustive list). In neuraxial application, anaesthetics/analgesics 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. Neuraxial application procedures include continuous infusion of wounds with local anaesthetic agents.
NOTE 2 Local anaesthesia/analgesia injected hypodermically and systemic injection of anaesthetics are not considered neuraxial applications.
This document is applicable to the following types of devices:
-- spinal/epidural catheter systems;
-- spinal/epidural port catheter systems;
-- peripheral nerve block catheter systems;
-- wound infusion catheter systems (also known as catheters for Surgical Site Continuous Analgesia).
This document is not applicable to:
-- pumps and other devices intended to deliver medications through these catheter systems;
-- catheters generically intended to administer substances into the body which are not intended to interact directly with the nervous system, but which have an indirect effect on nervous system (e.g. cannula needles);
-- drainage catheters for any other application than neuraxial.