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 054 Date of Entry 07/06/2020 
FR Recognition Number 12-331
Standard
NEMA  Standards Publication MS 14-2019
Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems
Scope/Abstract
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 worst-case normal use conditions when in a volume transmit coil. Non-volume transmit-receive array coils, non-volume transmit array coils, and detachable coils with their own RF screen/shield are out of scope for this edition and may be considered in a future revision. Additional thoughts regarding the applicability of the Standard to out of scope coils are found in appendix B. This Standard provides recommendations for coils configured for intended use, consideration for systems operating in a B1 shimmed configuration, multi-frequency coils, and the unplugged condition. The methods described may be applicable to other coil types, with appropriate modifications.

Gradient induced heating is out of scope. Certain large surface area RF coil designs may experience additional incremental heating due to intensive gradient activity. Users of this Standard will identify and adapt appropriate methods as necessary.

Consult with local regulations and IRBs when applying these methods to research, prototype, or investigational device coils.

All uses of "Note:" are to be interpreted as informative, not normative text in this Standard.
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
§892.1200 Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance Class 2 OUO
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 Contact
 Daniel Krainak
  FDA/OC/CDRH/OPEQ/OIDRH/DRH/MREPB/
  301-796-0478
  Daniel.Krainak@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.
-
-