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.

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. suction catheters;

2. tracheal catheters;

3. urethral catheters;

   NOTE See ISO 20696.

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

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

5. drainage catheters placed in digestive tracts percutaneously with gastrostomy technique;

6. neuraxial catheters used for removal of cerebrospinal fluid;

   NOTE See ISO 20698.

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

   NOTE See ISO 20695.

8. coatings.