Recognized standard
RP-27.1-2015
FDA recognition 12-297 · ANSI · Radiology
Key facts
| Recognition number | 12-297 |
|---|---|
| Designation | RP-27.1-2015 |
| Title | Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - General Requirements |
| Standards developer | American National Standards Institute |
| Specialty area | Radiology |
| Date of entry | Jun 27, 2016 |
| Device classes | Class 2 |
| Scope (excerpt) | The purpose of these standards is to inform the public and original equipment manufacturers (OEMs) about potential radiation hazards that may be associated with various lamps and lamp systems. It is also the purpose of these standards to provide guidance, advice, and standard methods for evaluating… |
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: