Recognized standard
60601-2-22 Edition 4.0 2019-11
FDA recognition 12-356 · IEC · Radiology
Key facts
| Recognition number | 12-356 |
|---|---|
| Designation | 60601-2-22 Edition 4.0 2019-11 |
| Title | Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Radiology |
| Date of entry | May 29, 2024 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of laser equipment for surgical, therapeutic, medical diagnostic, cosmetic or veterinary applications, intended for use on humans or animals, classified as LASER PRODUCT of CLASS 1C where the ENCLOSED LASER is of CLASS 3B… |
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: