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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 043 Date of Entry 06/27/2016 
FR Recognition Number 12-295
IEC 60601-2-33 Ed. 3.2 b:2015 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized
Clause: 201.12.4.101.3.
Transition Period
FDA recognition of IEC 60601-2-33 Edition 3.0: 2010 [Rec# 12-207] and IEC 60601-2-33 Edition 3.1: 2013 [Rec# 12-271] will be superseded by recognition of IEC 60601-2-33 Edition 3.2 2015-06 [Rec# 12-295]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec # 12-207] and [Rec# 12-271] until December 31, 2018. After this transition period, declarations of conformity to [Rec # 12-207] and [Rec# 12-271] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§892.1000 Coil, Magnetic Resonance, Specialty Class 2 MOS
§892.1000 Mri Disposable Kit Class 2 OIM
§892.1000 System, Nuclear Magnetic Resonance Imaging Class 2 LNH
§892.1000 System, Nuclear Magnetic Resonance Spectroscopic Class 2 LNI
Relevant FDA Guidance and/or Supportive Publications*
AAMI CR500:2019 Basic Introduction to the IEC 60601 Series

Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices. Document issued on: November 14, 1998

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073817.htm

Guidance for Industry and FDA Staff Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices. Document issued on: July 14, 2003
FDA Technical Contacts
 Wolfgang Kainz
  FDA/OC/CDRH/OSEL/DBP/
  301-796-7595
  wolfgang.kainz@fda.hhs.gov
 Jana Delfino
  FDA/OC/CDRH/OPEQ/OIDRH/DRH/MREPB/
  301-796-6503
  jana.delfino@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
Radiology
*These are provided as examples and others may be applicable.
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