DS/EN ISO 20697:2018

Sterile drænagekatetre og tilbehør til engangsbrug

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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.

Antal sider: 46

Udgivet: 2018-07-11

Godkendelsesdato: 2018-07-09

Internationale relationer : EN ISO 20697:2018 IDT ISO 20697:2018 IDT

ICS: 11.040.25 - Sprøjter, kanyler og katetre

Varenummer: M313161

Udvalg og komiteer


  • CEN/TC 205
  • CEN/TC 205/WG 16
  • ISO/TC 84
  • ISO/TC 84
  • ISO/TC 84/WG 9
  • ISO/TC 84/WG 9

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