A-A-51690A
Alternate safety (skin contact) test. The manufacturer may submit an alternate test protocol for the Safety Test to the Directorate of Medical Materiel, ATTN: DPSC-RST, DPSC, 2800 S. 20th Street, Philadelphia, PA 19101. If the alternate test is deemed acceptable, the manufacturer shall be issued in lieu of the Safety Test above on that and future contracts. The protocol shall include a description of the method, apparatus, positive and negative controls, and acceptance, the manufacturer shall be issued a letter-of-equivalency, and the alternate test may be used in lieu of the Safety Test above on that and future contracts. The protocol shall include a description of the method, apparatus, positive and negative controls, and acceptance/rejection criteria.
Certificates of safety. 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 method of processing since actual testing was performed. The certificate shall include the date of actual testing, the test method and results, the name and title of the person evaluating results, the current contract number and NSN, a statement to the effect that material processing and formulation have not changed since actual testing 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.
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.
For Parts Inquires call Parts Hangar, Inc (727) 493-0744
© Copyright 2015 Integrated Publishing, Inc.
A Service Disabled Veteran Owned Small Business