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DS/EN ISO 20697

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

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Organization: DS
Publication Date: 9 July 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/EN ISO 20697
July 9, 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...
Sterile drainage catheters and accessory devices for single use (ISO/FDIS 20697:2018)
This standard specifies requirements for sterile,single use drainage catheters, wound drainage systems and components thereof designed for drainage of fluids tothe exterior by means of gravity or...
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