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;