Recognized standard
60601-2-2 Edition 6.1 2023-02 CONSOLIDATED VERSION
FDA recognition 6-521 · IEC · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-521 |
|---|---|
| Designation | 60601-2-2 Edition 6.1 2023-02 CONSOLIDATED VERSION |
| Title | Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories [Including: Amendment 1 (2023), Interpretation Sheet 1 (2025)] |
| Standards developer | International Electrotechnical Commission |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | May 25, 2026 |
| Device classes | Class 2 |
| Scope (excerpt) | This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HF SURGICAL EQUIPMENT and HF SURGICAL ACCESSORIES as defined in 201.3.224 and 201.3.223. HF SURGICAL EQUIPMENT having a RATED OUTPUT POWER not exceeding 50 W (for example for micro-COAGULATION, or for use in dentistry or… |
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: