Recognized standard
60601-2-57 Edition 2.0 2023-07
FDA recognition 12-355 · IEC · Radiology
Key facts
| Recognition number | 12-355 |
|---|---|
| Designation | 60601-2-57 Edition 2.0 2023-07 |
| Title | Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | May 29, 2024 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | This International Standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of equipment incorporating one or more sources of OPTICAL RADIATION in the wavelength range 200 nm to 3 000 nm, with the exception of laser radiation, and intended to create non-visual photobiological effects in humans or… |
At a glance
- 1–9 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: