Recognized standard
60601-2-22 Edition 3.1 2012-10
FDA recognition 12-268 · IEC · Radiology
Key facts
| Recognition number | 12-268 |
|---|---|
| Designation | 60601-2-22 Edition 3.1 2012-10 |
| 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 | Jan 14, 2014 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of laser equipment for either surgical, therapeutic, medical diagnostic, cosmetic, or veterinary applications, intended for its use on humans or animals, classified as a CLASS 3B or CLASS 4 LASER PRODUCT as defined by… |
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: