DS/EN ISO 20697:2018

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


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 85.95

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.


Number of pages: 46

Published: 2018-07-11

Date of approval: 2018-07-09

International relationships : EN ISO 20697:2018 IDT ISO 20697:2018 IDT

ICS: 11.040.25 -

Syringes, needles and catheters

Item number: M313161


Committees

Committee

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

Danish committee

DS/S-093