COMMERCIAL ITEM DESCRIPTION A-A-51636A
Certificates 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 method of processing since actual testing was performed. The certificate shall include the date of actual testing, the test method and results, the name and title of the person evaluating results, the current contract number and NSN, a statement to the effect that material processing and formulation have not changed since actual testing was performed, and the signature and title of the person making the certification.
Tubing hardness. Plastic tubing hardness shall be determined in accordance with ASTM D2240 Standard Test Method for Rubber Property-Durometer Hardness. The test shall be conducted at a room temperature of 27° plus or minus 5° (80° plus or minus 9°F) on samples which had been conditioned at this temperature for not less than three hours prior to testing. The test sample shall be laminated to a thickness of not less than 1/4 inch. The gage reading shall be made 15 seconds after application of the instrument.
Accelerated aging test. Preheat an air oven to 140° ± 1.8° prior to placing the syringe into the oven. The syringe shall stay in the oven for nine days. The appearance of the syringe before and after the aging test shall be noted. Any cracking or other deterioration shall constitute failure of the test. Attach the syringe to an intravenous container filled with water and operate the syringe. If the syringe leaks or does not deliver fluid properly, it shall be rejected.
Bacterial retention. Detach the spike assembly from the sterile tubing by sealing and cutting the plastic tube within 3 inches of the spike assembly making sure that the tubing interior remains sterile. A regular parenteral 1000 ml bottle having a standard closure shall be filled with 50 ml of fluid thioglycollate medium, USP, evacuated to at least 25 inches of mercury, sealed and sterilized. Introduce a sufficient concentration of Aspergillus aerogenes into a number 44 DeVilbiss nebulizer or similar apparatus. Connect the nebulizer to the air filter on the spike by means of gum rubber tubing with the necessary reducers and connectors. Adjust the concentration of organisms in the nebulizer to obtain a minimum of 300 organisms in the air volume replacing the vacuum in the liter
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