CEN/TC 205/WG 16 - 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 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 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.