A-A-51508B
Vacuum test. Manually evacuate the air from the syringe by compressing the top of the bulb until it touches the opposite wall. Attach the syringe to a mercury fill “U” tube with one foot of 3/16 to 1/4 inch inside diameter flexible tubing. The syringe shall create vacuum, of 76 mm Hg (minimum).
Sterility. The syringe shall be sterile in accordance with the USP, or Association for the Advancement of Medical Instrumentation (AAMI) requirements. sterility assurance level shall be 0.0001.
Safety and Freedom from pyrogens. The syringe shall be tested for safety and freedom from pyrogens in accordance with USP.
Certificate of biocompatibility. A certificate of compliance, stipulating that offered items meet the biocompatibility test, shall be acceptable, provided that the contractor has supplied acceptable items to the Government within the past three years and that there have been no changes to material formulation and the method of processing since actual testing was performed. The processing since actual testing was performed. The certificate shall include the date the testing was performed, the test method and results, the name and title of the person evaluating the results, the current contract number and National Stock Number (NSN), a statement certifying that material processing and formulation have not changed since the time that biocompatibility was performed and the signature and title of the person making the certification.
Workmanship. The aspirating syringe shall be free from defects which detract from its appearance or impair its serviceability.
Unit. Package (PG). One package containing fifty syringes of one size only, as specified, constitutes one unit. Each syringe shall be individually packaged sterile in a sealed peel-open container capable of maintaining sterility of contents unless package is damaged or opened.
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