CFR section
21 CFR 1040.10(e)(2): Laser products
PART 1040-PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS
Key facts
| Citation | 21 CFR 1040.10(e)(2) |
|---|---|
| Section | Laser products |
| Part | PART 1040-PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS |
| Subchapter | 21 CFR J Radiological |
| Product types cited | Devices |
| Regulation text (excerpt) | (2) Test conditions. Except as provided in § 1010.13, tests for compliance with each of the applicable requirements of this section and § 1040.11 shall be made during operation, maintenance, or service as appropriate: (i) Under those conditions and procedures which maximize the accessible emission levels, including start-up, stabilized emission, and shut-down of the laser product; and (ii) With all controls and adjustments listed in the operation, maintenance, and service instructions adjusted… |
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Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.