What specific information should be contained in the “declaration of conformity?
The elements that should be in a declaration are included in the guidance document, “Recognition and Use of Consensus Standards” under the heading, “Procedures for the Use of Consensus Standards.” If you submit a declaration of conformity, it should: • identify the applicable recognized consensus standards that were met • specify, for each consensus standard, that all requirements were met, except for inapplicable requirements or deviations as described below • identify, for each consensus standard, any way(s) in which the standard may have been adapted for application to the device under review, e.g., identify which of an alternative series of tests were performed • identify, for each consensus standard, any requirements that were not applicable to the device • specify any deviations from each applicable standard that was applied (e.g., deviations from international standards that are necessary to meet U.S. infrastructure conventions such as the National Electrical Code (ANSI/NFPA 70)
