Recognized standard
MS 8-2016
FDA recognition 12-315 · NEMA · Radiology
Key facts
| Recognition number | 12-315 |
|---|---|
| Designation | MS 8-2016 |
| Title | Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems |
| Standards developer | National Electrical Manufacturers Association |
| Specialty area | Radiology |
| Date of entry | Jun 7, 2018 |
| Device classes | Class 2 |
| Scope (excerpt) | This NEMA Standards Publication describes two measurement procedures for whole-body SAR measurements, the calorimetric method and the pulse-energy method. Extrapolation of these data to patient temperature rise is beyond the scope of this document. This document does not apply to gradient… |
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: