A-A-54575 Draining Kit, Closed Suction Jackson-Pratt

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A-A-54575

The reservoir shall have an overall length of 4.75 ± 0.25 inches when measured from the suction reservoir tip to the bottom of the reservoir. The reservoir shall have an outside diameter of 2.20 ± 0.2 inches at the point of maximum diameter. The reservoir shall have a minimum internal volume of 125 milliliters (ml).

Graduations. The reservoir shall be graduated in 25 ml increments from 25 to 100 ml. Each graduation line shall extend around the circumference of the bulb and shall be numbered. The reservoir shall bear the letters “cc” or “ml” beside or near the 100 ml graduations. Graduations shall be accurate to within ± 10 percent of the labeled volume. Accuracy shall be tested with water and a graduated cylinder.

Performance. Finished reservoirs shall be tested in accordance with the vacuum and flow rate test.

Vacuum test. Attach a manometer or pressure gauge to the suction port. Manually or mechanically evacuate the air from the reservoir and install the reservoir drain plug. Release the reservoir. The reservoir shall create a minimum vacuum of 85 mm of mercury, and shall hold the vacuum for a minimum of 2 minutes.

Flow rate test. Mount the reservoir by the strap above a supply basin of water at room temperature such that a hydrostatic head of 7 ± 1/8 inches exists from the water level in the basin to the entrance of the reservoir. The reservoir may be held by a mechanism other than the strap as long as the reservoir shape recovery and the vacuum induced are not influenced by the mechanism and the 7 inch head is maintained. Manually or mechanically evacuate the air from the reservoir, install the reservoir drain plug, and release the reservoir. The reservoir shall collect 33-45 ml of water in 2 minutes.

Radiopacity. The flat portion shall be radiopaque throughout its length in accordance with ASTM Designation F640.

Sterility and Pyrogenocity. The drainage kit shall be sterile and free from pyrogens and shall be tested for sterility and pyrogenocity in accordance with the United States Pharmacopeia (USP). Sterility assurance level shall be 0.000001.