A-A-53450
Sampling for tests. Sampling for tests including dimensional test, shall be conducted in accordance with MIL-STD-105, with an AQL of 2.5 (percent defective) and inspection level of S-1. The unit of product for test purposes shall be one sterilization wrapper.
Tests.
Sterilization test.
Typical surgical supplies shall be placed inside the sterilization wrapper, sealed with sterilizer indicator tape, and autoclaved with steam at 250°F and 15 pounds pressure for 30 minutes. The wrapper shall then be inspected for hardness, brittleness, and resistance to puncturing or tearing. Any excessive hardness brittleness, or tendency to puncture or tear, shall constitute a defect.
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, as amended, and as implemented by Federal Acquisition Regulation Subpart 23.4 to the maximum extent practical.
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