BS EN ISO 20697:2018 - Page 2

Sterile drainage catheters and accessory devices for single use. | Status: Confirmed, Current

1 Scope 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:

1. a) suction catheters;
2. b) tracheal catheters;
3. c) urethral catheters;

   NOTE See ISO 20696.

4. d) ureteral stents, biliary stents, and other stents;

   NOTE See ISO 14630 and ASTM F1828‑97 for stents requirements.

5. e) drainage catheters placed in digestive tracts percutaneously with gastrostomy technique;
6. f) neuraxial catheters used for removal of cerebrospinal fluid;

   NOTE See ISO 20698.

7. g) enteral catheters used for removal of solutions or substances from the gastrointestinal tract;

   NOTE See ISO 20695.

8. h) coatings.