CFR section
21 CFR 1040.11(a)(1): Specific purpose laser products
PART 1040-PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS
Key facts
| Citation | 21 CFR 1040.11(a)(1) |
|---|---|
| Section | Specific purpose laser products |
| Part | PART 1040-PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS |
| Subchapter | 21 CFR J Radiological |
| Product types cited | Devices |
| Regulation text (excerpt) | (1) Incorporate in each Class III or IV medical laser product a means for the measurement of the level of that laser radiation intended for irradiation of the human body. Such means may have an error in measurement of no more than 20 percent when calibrated in accordance with paragraph (a)(2) of this section. Indication of the measurement shall be in International System Units. The requirements of this paragraph do not apply to any laser radiation that is all of the following: (i) Of a level… |
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