CFR section
21 CFR 1020.30(d)(1): 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)(1) |
|---|---|
| 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) | (1) Reports of assembly. All assemblers who install certified components shall file a report of assembly, except as specified in paragraph (d)(2) of this section. The report will be construed as the assembler's certification and identification under §§ 1010.2 and 1010.3 of this chapter. The assembler shall affirm in the report that the manufacturer's instructions were followed in the assembly or that the certified components as assembled into the system meet all applicable requirements of §§… |
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