1 Scope
1.1 This performance specification establishes performance requirements for the short-term
utilization of a single-use, non-balloon-urinary catheter, French sizes 12 through
30 inclusive, used by the medical professions for providing a method of bladder drainage
through the urethra. The product is manufactured in various sizes and materials such
as latex, silicone, rubber, and various polymers (as well as combinations of these)
and is provided non-sterile and sterile for single use only. The non-sterile catheters
should be sterilized.