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BSI BS EN ISO 20697:2018

Sterile drainage catheters and accessory devices for single use
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BSI BS EN ISO 20697:2018

Sterile drainage catheters and accessory devices for single use

PUBLISH DATE 2018
PAGES 46
BSI 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.

SDO BSI: British Standards Institution
Document Number ISO 20697
Publication Date Sept. 18, 2018
Language en - English
Page Count 46
Revision Level
Supercedes
Committee CH/84
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