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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 12-214
Standard
IEC  62220-1-3 Edition 1.0 2008-06
Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging
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 1-3 is restricted to DIGITAL X-RAY IMAGING DEVICES that are used for dynamic imaging such as, but not exclusively, direct and indirect flat panel-detector based systems.

It is not recommended to use this part of IEC 62220 for digital X-RAY IMAGE INTENSIFIER-based systems.

NOTE 1 This negative recommendation is based on the low frequency drop, vignetting and geometrical distortion present in these devices which may put severe limitations on the applicability of the measurement methods described in this standard.

This part of IEC 62220 is not applicable to:

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

- COMPUTED TOMOGRAPHY; and

- systems in which the X-ray field is scanned across the patient.

NOTE 2 The devices noted above are excluded because they contain many parameters (for instance, beam qualities, geometry, time dependence, etc.) which differ from those important for dynamic imaging. Some of these techniques are treated in separate standards (IEC 62220-1 and IEC 62220-1-2).
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
§892.1680 Solid State X-Ray Imager (Flat Panel/Digital Imager) Class 2 MQB
Relevant FDA Guidance and/or Supportive Publications*
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
 James Graves
  CDRH/OPEQ/OIDRH/DRH/DXRS/
  301-796-4443
  James.Graves@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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