A-A-51915A
Tests.
1. Safety. If unit is line powered, electrical leakage current shall comply with those limits specified in ANSI/AAMI SCL 12/78. Tests shall be in accordance with above standard. Equipment shall be a leakage current tester/safety analyzer with capability to perform tests described in above standard.
2. Performance. The manufacturer shall demonstrate to the Government via mutually acceptable test methods, compliance with the following specifications and performance criteria:
Waveforms – trapezoidal or LOWN, 2 to 40 mS duration.
Energy measurement range – to 800 joules, ± 4 percent.
Test load – 50 ohms, ± 1 percent.
Waveform amplitude – 5kV.
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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