Recognized standard
60601-2-10 Edition 2.1 2016-04
FDA recognition 17-16 · IEC · Neurology
Key facts
| Recognition number | 17-16 |
|---|---|
| Designation | 60601-2-10 Edition 2.1 2016-04 |
| Title | Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators |
| Standards developer | International Electrotechnical Commission |
| Specialty area | Neurology |
| Date of entry | Jun 7, 2018 |
| Device classes | Class 2 |
| Scope (excerpt) | This international standard specifies the requirements for the safety of nerve and muscle stimulators defined in sub clause 2 01.3.204, for use in the practice of physical medicine, hereinafter referred to as ME equipment. This includes transcutaneous electrical nerve stimulators (TENS) and… |
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: