COMMERCIAL ITEM DESCRIPTION A-A-51884
Sterility test. The cholangiography catheter shall be tested for sterility in accordance with the method specified in the USP for parenteral devices using inoculated product. Or paper spore stripe (carrier). Product containing a biological indicator shall be marked or labeled so that it clearly differentiates from product intended for distribution. The minimum number of test units, regardless of lot size, shall be 10.
Alternate method. Supplier conducting sterility test shall submit proof that the alternate method provides equal assurances concerning the sterility of the product. However, all sterility tests shall be conducted using biological indicators. Requests for approval of any alternate method of testing for sterility shall be made to the contracting officer, and approval obtained before employment of the alternate method on a government contract.
Radiopacity test. The catheter shall be in accordance with ASTM F640-79.
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.
Recovered materials. The offeror/contractor is encouraged to use recovered materials in accordance with Public Law 94-580 to the maximum extent practical.
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