A-A-51492B
One tissue forceps with serrated jaws, 5 inches (13 cm) with dimensions within 1/2 inch and one straight Kelly hemostat 5-1/2 inches (14 cm) with dimensions within 3/4 inch. These instruments shall be fabricated of nickel-plated steel, and as an alternate, the tissue forceps may have securely attached serrated jaws of a suitable alloy. The hemostat pin or rivet shall be either stainless steel or nickel plated steel. Flashings of nickel shall be 0.0002 inch minimum. The instruments shall be without rough edges, burrs and any sign of corrosion. Instruments shall comply with their respective performance tests.
Forceps performance test. The instrument shall have no looseness or free play of either shank which would result in any misalignment of the tips in closing. Upon closing, tips which do not meet shall be rejected. Upon completion of test, the instrument shall undergo repetition a second time with the same criteria.
Hemostat performance test. In addition to compliance with the forceps test, the hemostat pin or rivet shall be permanently secured, insuring no free play of the shanks. Upon closing the hemostat, tips that do not successively tighten from the extreme distal tip shall be rejected. In the fully closed position, the hemostat shall have no visible gap on the mating surface.
Sterility and Pyrogenicity. Components shall be sterile and free from pyrogens. The kits shall have a minimum sterility assurance level of 0.000001 and shall be in accordance with the USP.
Workmanship. The incision and drainage set shall be free from defects which detract from its appearance or impair its serviceability.
Expiration dating. Expiration dating period of the set shall not be less than 24 months. Not less than 5/6 of the expiration dating period shall remain at the time of delivery to the Government.
Unit. Package (PG). One package containing twenty sets, each set packaged sterile in a sealed peel–open tray with items positioned within the tray in sequence of use, as specified, constitutes one unit.
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