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AbstractAbstract
[en] This manual has been developed by the NCDRH (formerly the Bureau of Radiological Health), FDA, to establish procedures for routine testing of diagnostic x-ray systems for compliance with Federal Performance Standard 21 CFR 1020.30. It has been prepared to instruct FDA personnel and state officials who assist FDA in its functions in the use of the various devices that FDA may procure. The procedures and routine test equipment will be used for screening diagnostic x-ray systems for evidence of noncompliance with the Performance Standard. More rigorous followup testing will be performed as required. The manual has two major subject areas: (1) testing procedures and (2) test equipment. The first section presently contains procedures that provide efficient means of testing against many performance requirements and are applicable to many different types of x-ray systems. The second section describes each component of the routine compliance test system. It includes detailed drawings of the routine compliance test stand, operating manuals for the x-ray exposure monitor and the photometer, and descriptions of how to use the direct-print paper
Primary Subject
Source
Dec 1983; 270 p; Available from NTIS, PC A12/MF A01
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Report
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INIS VolumeINIS Volume
INIS IssueINIS Issue