Recognized standard
TR 60601-4-2 Edition 1.0 2016-05
FDA recognition 19-19 · IEC · General II (ES/EMC)
Key facts
| Recognition number | 19-19 |
|---|---|
| Designation | TR 60601-4-2 Edition 1.0 2016-05 |
| Title | Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems |
| Standards developer | International Electrotechnical Commission |
| Specialty area | General II (ES/EMC) |
| Date of entry | Sep 17, 2018 |
| Scope (excerpt) | This part of IEC 60601 applies to the performance of MEDICAL ELECTRICAL EQUIPMENT or a MEDICAL ELECTRICAL SYSTEM in the presence of ELECTROMAGNETIC DISTURBANCES. Hereafter, MEDICAL ELECTRICAL EQUIPMENT or a MEDICAL ELECTRICAL SYSTEM are referred to as ME EQUIPMENT or an ME SYSTEM. |
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: