ISO/TC 84/WG 9 - Catheters

This document specifies requirements for enteral feeding systems comprising enteral giving sets, enteral extension sets, enteral syringes, enteral feeding catheters, and enteral accessories. This document is not applicable to oral syringes.

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.

This document specifies requirements and test methods for sterile urethral catheters for single use, with or without a balloon. This document does not include drainage catheters covered by ISO 20697, e.g. ureteral catheters, nephrostomy catheters, and suprapubic catheters. This document also excludes ureteral stents. NOTE Ureteral stents are covered in ASTM F1828‑97.

This document specifies requirements for sterile, single use drainage catheters, wound and fluid accumulation drainage systems, surgical drainage catheters and their components, where the catheter is placed in a body cavity or wound, surgically or percutaneously, for drainage of fluid or air to the exterior. The drainage catheter is left to drain naturally or connected to a suction source for faster tissue granulation. This document is not applicable to: a) suction catheters; b) tracheal catheters; c) urethral catheters; NOTE See ISO 20696. d) ureteral stents, biliary stents, and other stents; NOTE See ISO 14630 and ASTM F1828‑97 for stents requirements. e) drainage catheters placed in digestive tracts percutaneously with gastrostomy technique; f) neuraxial catheters used for removal of cerebrospinal fluid; NOTE See ISO 20698. g) enteral catheters used for removal of solutions or substances from the gastrointestinal tract; NOTE See ISO 20695. h) coatings.

This document specifies general requirements and test method for peripherally inserted central catheters (PICC), supplied in the sterile condition and intended for single use, for any application. It is not applicable to intravascular catheter accessories, e.g. those covered by ISO 11070.