This draft of Egyptian standard 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 draft standard 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;
e) Drainage catheters placed in digestive tracts percutaneously with gastrostomy technique;
f) Neuraxial catheters used for removal of cerebrospinal fluid;
g) Enteral catheters used for removal of solutions or substances from the gastrointestinal tract;
h) Coatings.
Worth mentioning is that this draft standard adopts the technical content of ISO 20697:2018 .
Syringes, needles and catheters (ICS code(s): 11.040.25)
