ISO 20697:2018

Current Revision
Sterile drainage catheters and accessory devices for single use

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Sterile drainage catheters and accessory devices for single use

PUBLISH DATE 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:

  • 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.
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