CFR section

21 CFR 1020.30(d): Diagnostic x-ray systems and their major components

PART 1020-PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS

Key facts

Citation 21 CFR 1020.30(d)
Section Diagnostic x-ray systems and their major components
Part PART 1020-PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS
Subchapter 21 CFR J Radiological
Product types cited Devices
Regulation text (excerpt) (d) Assemblers' responsibility. An assembler who installs one or more components certified as required by paragraph (c) of this section shall install certified components that are of the type required by § 1020.31, § 1020.32, or § 1020.33 and shall assemble, install, adjust, and test the certified components according to the instructions of their respective manufacturers. Assemblers shall not be liable for noncompliance of a certified component if the assembly of that component was according to…

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