BS EN ISO 20697:2018

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: suction catheters; tracheal catheters; urethral catheters; NOTE See ISO20696. ureteral stents, biliary stents, and other stents; NOTE See ISO14630 and ASTMF1828‑97 for stents requirements. drainage catheters placed in digestive tracts percutaneously with gastrostomy technique; neuraxial catheters used for removal of cerebrospinal fluid; NOTE See ISO20698. enteral catheters used for removal of solutions or substances from the gastrointestinal tract; NOTE See ISO20695. coatings.