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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 025 Date of Entry 10/04/2010 
FR Recognition Number 12-213
Standard
IEC  62220-1-2 Edition 1.0 2007-06
Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography
Scope/Abstract
This part of IEC 62220 specifies the method for the determination of the DETECTIVE QUANTUM EFFICIENCY (DQE) of DIGITAL X-RAY IMAGING DEVICES as a function of AIR KERMA and of SPATIAL FREQUENCY for the working conditions in the range of the medical application as specified by the MANUFACTURER. The intended users of this part of IEC 62220 are manufacturers and well equipped test laboratories.

This Part 1-2 is restricted to DIGITAL X-RAY IMAGING DEVICES that are used for mammographic imaging such as but not exclusively, CR systems, direct and indirect flat panel detector based systems, scanning systems (CCD based or photon-counting). This part of IEC 62220 is not applicable to

- DIGITAL X-RAY IMAGING DEVICES intended to be used in general radiography or in dental radiography;

- computed tomography;

and

- devices for dynamic imaging (where series of images are acquired, as in fluoroscopic or cardiac imaging).
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
§892.1715 Full Field Digital, System, X-Ray, Mammographic Class 2 MUE
Relevant FDA Guidance and/or Supportive Publications*
Draft Guidance of Industry and FDA Staff: Class II Special Controls Guidance Document: Full Field Digital Mammography System, May 30, 2008

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
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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