A-A-53326
Ethylene Oxide Indicator Test. The ETO indicator of the envelope shall change to the degree required by the envelope instructions when exposed to a standard ETO cycle. Not test failure shall be permitted.
Seal strength test. A test sample 1.0 inch wide by 2-1/2 inches long shall be cut from the envelope. The manufacturer’s seal shall lie along one of the 1 inch edges. One of the flaps shall be lightly folded back against the seal to form a test specimen 1.0 inch wide by approximately 4-1/2 inches long. A tensile force of 350 grams shall be applied to the 1 inch ends of the specimen. The seal shall not fully part. If the seal fully parts, it 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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