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Proceedings Paper

Questions and Answers
Author(s): A.Van Art; Robert G. Britain
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Paper Abstract

Question by Mr. A. Van Art, Litton Medical Systems: Can the customer modify his certified equipment as he wishes without taking on the burden of himself becoming a "manufacturer" as defined by the standard? Answer by Robert G. Britain, Director, Div. of Compliance, BRH: Unless the question is further qualified as to what type of modification would be made, such action would not be recommended on the basis of the policy expressed in the preamble to the Federal standard for diagnostic x-ray equipment when it was published in the FEDERAL REGISTER as a final rule on August 15, 1972 (37 FR 16462): "The purchaser who redesigns or modifies certified components in, or removes certified components from, an x-ray system would also be considered an assembler, hence a manufacturer, and thus must be authorized by a variance for changes which cause certified components in the systems not to meet the stan-dard. If he orders special, nonconforming equipment from a component manufacturer, the component manufacturer must also petition for a variance. There would be no need to obtain a variance to modify systems which are not to be used for diagnosis or visualization of humans, nor to perform routine repair or maintenance."

Paper Details

Date Published: 25 March 1976
PDF: 3 pages
Proc. SPIE 0070, Application of Optical Instrumentation in Medicine IV, (25 March 1976); doi: 10.1117/12.954608
Show Author Affiliations
A.Van Art, Litton Medical Systems: (United States)
Robert G. Britain, Div. of Compliance, BRH (United States)

Published in SPIE Proceedings Vol. 0070:
Application of Optical Instrumentation in Medicine IV
Joel E. Gray; William R. Hendee, Editor(s)

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