Abstract Preview

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.


General information

  • Status :  Published
    Publication date : 2018-06
    Corrected version (en) : 2018-08
    Corrected version (fr) : 2018-08
  • Edition : 1
    Number of pages : 37
  • :
    ISO/TC 84
    Devices for administration of medicinal products and catheters
  • 11.040.25
    Syringes, needles and catheters

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