A-A-51945
Records. Records of examinations and tests performed by or for the contractor shall be maintained by the contractor and made available to the Government upon the Government’s request, at any time, or from time to time, during the performance of the contract and for a period of three years after delivery of the supplies to which such records relate.
Inspection. Inspection, as used herein, is defined as both examination (such as visual or auditory investigation without the use of special laboratory appliances or procedures) and testing (determination by technical means of physical and chemical properties) of the item.
First article inspection. First article inspection shall be performed on the electrocardiograph (ECG) when a first article sample is required. This inspection shall include examination and tests.
Sampling for tests. Sampling for tests shall be conducted in accordance with commercial practice. The unit of product for test purposes shall be one electrocardiograph.
Tests. Tests shall be conducted to determine compliance with specification requirements.
Performance Test. The electrocardiograph shall be tested for compliance with requirements as follows:
a. Using an electronic patient simulator, a series of known normal and abnormal ECG’s shall be used to determine the unit’s ability to recognize, display, and store the data correctly. Storage of interpretation/analysis, waveform data and patient information will be examined. Correct morphological interpretation of the abnormalities listed under Salient Characteristics, paragraph 8, shall be verified.
b. The unit’s ability to correctly annotate all leads shall be verified. Lead switching, the availability and implementation of multiple formats and undistorted memory retrieval shall be examined to verify that the unit complies with contractor’s claims and government specification.
Metric products. Products manufactured to metric dimensions will be considered on an equal basis with those manufactured using inch-pound units, providing they fall within the tolerance specified using conversion tables contained in the latest revision of Federal Standard No. 376, and all other requirements of this document are met.
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