DS/EN ISO 20697
Sterile drainage catheters and accessory devices for single use (ISO 20697:2018)
|Publication Date:||9 July 2018|
|ICS Code (Syringes, needles and catheters):||11.040.25|
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.