Alcance
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.