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.

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.