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.
EN 20697:2018 history
2018EN 20697:2018 Sterile drainage catheters and accessory devices for single use