Recognized standard
RP-27.3-17
FDA recognition 12-321 · ANSI · Radiology
Key facts
| Recognition number | 12-321 |
|---|---|
| Designation | RP-27.3-17 |
| Title | Recommended Practice for Photobiological Safety for Lamps - Risk Group Classification and Labeling |
| Standards developer | American National Standards Institute |
| Specialty area | Radiology |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 2 |
| Scope (excerpt) | This standard covers the classification, labeling and informational requirements for lamps that emit optical radiation in the wavelength range from 200 nm to 3,000 nm, with exception for LED diodes used in optical fiber communication systems and for lasers. Lamps included are incandescent filament… |
At a glance
- 10–99 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: