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DS/ISO 20697

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

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Organization: DS
Publication Date: 4 September 2018
Status: active
Page Count: 46
ICS Code (Syringes, needles and catheters): 11.040.25
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: 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.

Document History

DS/ISO 20697
September 4, 2018
Sterile drainage catheters and accessory devices for single use (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...
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