A-A-53486
Defects.
Cover not fabricated of a medical grade copolymer material.
Cover not capable of heat sealing closure.
Cover has no tear lines for easy opening.
Cover not free of tears, holes, perforations, or thin spots.
Cover not clearly printed with “Instructions for use”.
Information block does not accept labeling by all point pens and most felt tip pens without smudging the writing.
Cover not free of oil, grease, dirt, or other foreign material.
Sampling for tests. Sampling for tests (dimensional) shall be conducted in accordance with MIL-STD-105, with an AQL of 2.5 (percent defective) and an inspection level of S-1. The unit of product for test purposes shall be one surgical dust cover.
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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