Sterile drainage catheters and accessory devices for single use
NORM herausgegeben am 1.1.2019
Bezeichnung normen: ČSN EN ISO 20697
Zeichen: 855828
Katalog-Nummer: 505988
Ausgabedatum normen: 1.1.2019
Zahl der Seiten: 52
Gewicht ca.: 156 g (0.34 Pfund)
Land: Tschechische technische Norm
Kategorie: Technische Normen ČSN
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