Recognized standard
60601-2-40 Third edition 2024-12
FDA recognition 17-20 · IEC · Neurology
Key facts
| Recognition number | 17-20 |
|---|---|
| Designation | 60601-2-40 Third edition 2024-12 |
| Title | Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Neurology |
| Date of entry | May 26, 2025 |
| Device classes | Class 2 |
| Scope (excerpt) | This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT, hereafter referred to as ME EQUIPMENT. NOTE 1 Myofeedback equipment, where the capturing of muscle contraction is based on electromyography, is within the scope of this… |
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: