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This standard specifies requirements and test methods for sterile urethral catheters for single use, with or without a balloon.
This standard does not include drainage catheters covered by ISO 20697 Sterile Drainage catheters for single use — e.g. ureteral catheters, nephrostomy catheters, and suprapubic catheters. This standard also excludes ureteral stents.
NOTE Ureteral stents are covered in ASTM F1828-97 Standard Specification for ureteral stents.
This document specifies requirements for sterile, single use drainage catheters, wound and fluid accumulation drainage systems, surgical drainage catheters and their components. 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 suction source for faster tissue granulation.
This document does not apply to:
a) suction catheters;
b) tracheal catheters;.
c) uretheral 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;
g) enteral Catheters used for removal of solutions or substances from the gastrointestinal tract;