Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 049 Date of Entry 06/07/2018 
FR Recognition Number 12-315
Standard
NEMA  MS 8-2016
Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems
Scope/Abstract
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 (low-frequency time-varying magnetic fields) safety where nerve and cardiac excitation are the primary safety issues. Neither is it intended to apply to spatial peak or local average SAR nor does it address other factors involved with patient heating. The tests specified are only for volume RF transmit coils that produce relatively homogeneous RF fields.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§892.1000 System, Nuclear Magnetic Resonance Imaging Class 2 LNH
§892.1000 System, Nuclear Magnetic Resonance Spectroscopic Class 2 LNI
§892.1000 Coil, Magnetic Resonance, Specialty Class 2 MOS
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and Food and Drug Administration Staff : Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, Issued November 2016.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Wolfgang Kainz
  FDA/OC/CDRH/OSEL/DBP/
  301-796-7595
  wolfgang.kainz@fda.hhs.gov
 Ting Song
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIA/
  301-796-7677
  ting.song@fda.hhs.gov
 Jana Delfino
  FDA/OC/CDRH/OPEQ/OIDRH/DRH/MREPB/
  301-796-6503
  jana.delfino@fda.hhs.gov
Standards Development Organization
NEMA National Electrical Manufacturers Association https://www.nema.org/
FDA Specialty Task Group (STG)
Radiology
*These are provided as examples and others may be applicable.
-
-