DIN EN ISO 20697:2017-03

This document specifies requirements for sterile, single use drainage catheters, wound and fluid accumulation drainage systems, surgical drainage catheters and their components. The drainage catheter is left to drain naturally or connected to suction source for faster tissue granulation. This document does not apply to: a) suction catheters; b) tracheal catheters;. c) uretheral catheters (see ISO 20696); d) Ureteral stents, biliary stents , and other stents (see ISO 14630 and ASTM F1828-97); e) drainage catheters placed in digestive tracts percutaneously with gastrostomy technique; f) neuraxial catheters used for removal of cerebrospinal fluid; g) enteral Catheters used for removal of solutions or substances from the gastrointestinal tract; h) coatings.