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ISO 20697:2018

M00004407

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

standard by International Organization for Standardization, 06/01/2018

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Full Description

Includes corrected version, September 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.