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U.S. Department of Health and Human Services

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Recognition List Number: 033 FR Publication Date: 01/14/2014 

Part B: Supplementary Information

Recognition Number 12-271: IEC 60601-2-33 Edition 3.1 2013-04, medical electrical equipment - part 2-33: particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis. (Radiology)

Date of Standard: 2013. 
Address of Standards Development Organization:
 International Electrotechnical Commission (IEC)
  3, Rue de Varembe'
  PO Box 131
  CH-1211 Geneva 20, 0
  SWITZERLAND
CDRH Office and Division associated with recognized standards:
OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)
Devices Affected:
Magnetic Resonance Imaging Systems, Magnetic Resonance Spectroscopic Systems, Magnetic Resonance Specialty Coils
Processes Affected:
510(k), PMA, PDP, IDE, HDE
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard and any annexes

Transition:
FDA recognition of IEC 60601-2-33 Edition 3.0 2010-03 [Rec# 12-207] will be superseded by recognition of IEC 60601-2-33 Edition 3.1 2013-04 [Rec# 12-271]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec # 12-207] until August 1, 2016. After this transition period, declarations of conformity to [Rec # 12-207] will not be accepted.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§892.1000 Coil, Magnetic Resonance, Specialty Class 2 MOS
§892.1000 Magnetic Resonance Imaging 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 Guidance:
Guidance for Industry
Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices. Document issued on: November 14, 1998

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/CDRH/OSEL
  10903 New Hampshire Avenue Building 62, Room 1132
  Silver Spring MD 20993
  301/796-2484
  email: wolfgang.kainz@fda.hhs.gov
 Jana Delfino
  FDA/CDRH/OIR
  10903 New Hampshire Avenue Building 66, Room 4236
  Silver Spring MD 20993
  301/796-6503
  email: jana.delfino@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
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