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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 026 Date of Entry 03/14/2011 
FR Recognition Number 12-221
IEC  61223-3-4 First edition 2000-03
Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray
This part of IEC 61223 applies to those components of dental X-RAY EQUIPMENT using radiographic imaging systems which influence the image quality and PATIENT dose.

This standard applies to the performance of the ACCEPTANCE TEST on dental X-RAY EQUIPMENT with intra-oral X-RAY IMAGE RECEPTOR and dental X-RAY EQUIPMENT with extra-oral X-RAY IMAGE RECEPTOR (for example, dental panoramic X-RAY EQUIPMENT or cephalometric X-RAY).

This standard applies to dental film and digital image acquisition and processing.
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
§872.1800 Unit, X-Ray, Extraoral With Timer Class 2 EHD
§872.1800 System, X-Ray, Extraoral Source, Digital Class 2 MUH
§872.1810 Unit, X-Ray, Intraoral Class 2 EAP
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 Contacts
 William Jung
 Michael Mendelson
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.