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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 12-302
Standard(Included in ASCA pilot)
IEC 60601-2-44 Edition 3.2: 2016
Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Sub-clause 203.108 Dosimetry PHANTOM
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§892.1750 System, X-Ray, Tomography, Computed Class 2 JAK
§892.1750 X-Ray, Tomography, Computed, Dental Class 2 OAS
Relevant FDA Guidance and/or Supportive Publications*
AAMI CR500:2019 Basic Introduction to the IEC 60601 Series

Guidance for Industry, FDA Staff and Third Parties - Provision for Alternate Measure of the Computed Tomography Dose Index (CTDI) to Assure Compliance with the Dose Information Requirements of the Federal Performance Standard for Computed Tomography. Document issued on October 20, 2006
FDA Technical Contacts
 Laurel Burk
  FDA/OC/CDRH/OPEQ/OIDRH/DRH/DXRS/
  301-796-5933
  laurel.burk@fda.hhs.gov
 Rongping Zeng
  FDA/OC/CDRH/OSEL/DIDSR/
  301-796-2546
  Rongping.Zeng@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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