A-A-53504B
The urometer graduations shall be in steps no larger than 10 cc. Urometer graduations shall begin at 10 cc and end at not less than 200 c. The following urometer graduations shall be identified: 10, 20, 30, 40, 50, 60, 70, 80, 100, 120, 140, 160, 180, and 200 cc. Identification of additional graduations shall be at least ± 5% for volumes less than 100 cc, and at least ± 10% for volumes greater than 100 cc.
The graduation markings shall be clear and indelible. They shall not be attached or secured with adhesives. The numbers and letters shall be a minimum of 0 .32 cm in height.
The adjustable hanger cord shall be nylon, cotton, or wax impregnated cotton, tightly woven, 0.5 cm to 1.0 cm long and 0.24 cm minimum diameter. The cord shall be furnished with a suitable corrosion resistant hook, capable of supporting the weight of a bag filled with 2000 cc of water for Size 1 and 2500 cc of water for Size 2. Plastic strap hangers or hook and loop hangers may be used in lieu of cord.
The urine collection bag shall be free of stains, holes, tears, cracks, or other imperfections, and shall not leak.
Each urine collection bag shall be supplied with comprehensive instruction sheet for use. As alternates, the instructions for use shall be permanently and legibly marked on each bag, or on each individual sterile bag wrapper.
Sterility. The urine collection bags shall be sterile in accordance with United States Pharmacopeia (USP) or Association for the Advancement of Medical Instrumentation (AAMI) requirements. Sterility assurance levels shall 0.000001.
Workmanship. The urine collection bag shall be free from defects which detract from its appearance or impair its serviceability.
Unit. Package (PG)
For Size 1, each urine collection bags shall be individually packaged in a suitable sealed container capable of maintaining sterility of contents unless packaged is damaged or opened. One package containing 10 individually packaged bags, as specified, constitutes one unit.
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