A-A-51514B
Bio compatibility. Plastic material shall be tested in accordance with the USP tests for Class IV plastics. Rubber material shall be tested in accordance with the Intramuscular and Intracutaneous sensitivity tests of the 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.
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.
Metric products. Products manufactured to metric dimensions will be considered on an equal basis with those manufactured using inch-pound units, providing they fall within the tolerance specified using conversion tables contained in the latest revision of Federal Standard 376, and all other requirements of this document are met.
If a product is manufactured to metric dimensions and those dimensions exceed the tolerances specified in the inch/pound units, a request should be made to the contracting officer to determine if the product is acceptable.
The contracting officer has the option of accepting or rejecting the product.
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