A-A-51258A
Capillary test. (for Type I and II). Held in a horizontal position, the sample capillary tubes shall be tested in accordance with currently accepted technique for hematocrit determination. The level to which the blood is drawn up within a 30 second period shall be noted.
Fluidity test. (for Type I only) The test shall be conducted by initially preparing recalcified sheep plasma by the following two step or equivalent process.
(a) Sheep plasma preparation. Sheep plasma shall be prepared in accordance with USP Assay for Sodium Heparin.
(b) Recalcify sheep plasma. To 10 millimeters (ml) of the prepared sheep plasma shall be added 2.0 ml of the 1.0% calcium chloride solution used in the heparin assay. The sheep plasma and calcium chloride solution shall be mixed well.
Heparin Content. (for Type I only) The Heparin content shall be determined by the method of assaying Sodium Heparin in the latest edition of USP. The result obtained shall represent the Heparin content on the inner surfaces of the tubes. No Heparin from the outside surface shall enter the test sample. Tubes shall contain a minimum of 3.0 USP units.
Contractor certification. The contractor shall certify and maintain substantiating evidence that the product offered meets the salient characteristics of this Commercial Item Description, and that the product conforms to the producers’ own drawings, specifications, standards, and quality assurance practices. The government reserves the right to require proof of such conformance prior to first delivery and thereafter as may be otherwise provided for under the provisions of the contract.
Regulatory requirements.
Federal Food, Drug and Cosmetic Act. If the product covered by this document has been determined by the U.S. Food and Drug Administration to be under its jurisdiction, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of Federal Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereunder. In addition, the offeror/contractor shall comply, and be responsible for compliance by its subcontractors/suppliers, with the requirements of all other applicable Federal, State, and local statutes, ordinances, and regulations.
Recovered materials. The offeror/contractor is encouraged to use recovered material in accordance with Public Law 94-580, as amended, and as implemented by Federal Acquisition Regulation Subpart 23.4 to the maximum extent practical.
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