CFR section
21 CFR 1040.10(f)(6)(i): Laser products
PART 1040-PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS
Key facts
| Citation | 21 CFR 1040.10(f)(6)(i) |
|---|---|
| Section | Laser products |
| Part | PART 1040-PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS |
| Subchapter | 21 CFR J Radiological |
| Product types cited | Devices |
| Regulation text (excerpt) | (i) Each laser system classified as a Class II, III, or IV laser product shall be provided with one or more permanently attached means, other than laser energy source switch(es), electrical supply main connectors, or the key-actuated master control, capable of preventing access by any part of the human body to all laser and collateral radiation in excess of the accessible emission limits of Class I and table VI. |
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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.