A-A-53467
The parts of the anatomy shall be number coded. There shall be no less than 604 coded structures.
The model shall be fabricated of suitable plastic with density varying appropriately with simulate human tissue of the organs and structures represented. The basic resins from which all parts of the model are fabricated shall be pigmented with colors to simulate human tissues. The coloring of anatomical detail and shaded tones may be done with vinyl base paints or permanent vinyl links, where necessary, to indicate specific structures.
The model shall be provided with a suitable protective cover and an instruction manual. The instruction manual shall completely describe the anatomical model and all coded parts.
Workmanship. The model shall be free from defects which detract from its appearance or impair its serviceability.
Unit. Each (EA). One model, as specified, constitutes one unit.
Contractor certification. The contractor shall certify that the product offered meets the salient characteristics of this description and 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.
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