Recognized standard
TS 60601-4-6 Edition 1.0 2024-04
FDA recognition 19-53 · IEC · General II (ES/EMC)
Key facts
| Recognition number | 19-53 |
|---|---|
| Designation | TS 60601-4-6 Edition 1.0 2024-04 |
| Title | Medical electrical equipment - Part 4-6: Guidance and interpretation - Voluntary guidance to help achieve basic safety and essential performance with regard to the possible effects of electromagnetic disturbances |
| Standards developer | International Electrotechnical Commission |
| Specialty area | General II (ES/EMC) |
| Date of entry | Dec 23, 2024 |
| Scope (excerpt) | This document provides practical methods to help achieve BASIC SAFETY and ESSENTIAL PERFORMANCE with regard to the possible effects of EM DISTURBANCES throughout the EXPECTED SERVICE LIFE of ME EQUIPMENT or an ME SYSTEM. These practical methods attempt to address all of the different types of… |
At a glance
- None 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: