Recognized standard
Standards Publication MS 14-2019
FDA recognition 12-331 · NEMA · Radiology
Key facts
| Recognition number | 12-331 |
|---|---|
| Designation | Standards Publication MS 14-2019 |
| Title | Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems |
| Standards developer | National Electrical Manufacturers Association |
| Specialty area | Radiology |
| Date of entry | Jul 6, 2020 |
| Device classes | Class 2 |
| Scope (excerpt) | This NEMA Standards publication describes measurement procedures for determining the maximum surface temperature of RF coils (integrated transmit, integrated receive, detachable receive, detachable transmit/receive, specialty coils), as specified in IEC 60601-1, due to absorbed RF power under… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
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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: