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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 040 Date of Entry 08/14/2015 
FR Recognition Number 12-290
Standard
IEC  61910-1 Edition 1.0 2014-09
Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy
Scope/Abstract
IEC 61910-1:2014 applies to radiation dose structured reports produced by X ray equipment that falls within the scope of IEC 60601-2-43:2010 or IEC 60601-2-54:2009. This document does not impose specific requirements on the accuracy of the reported or displayed data. Existing standards or regulations can have applicable requirements for accuracy and precision. This standard provides specific units and quantities and prescribes data storage formats. This document does not present any requirements on the form of display of dose information to operators or other individuals. The objective of this International Standard is to specify the minimum dataset to be used for reporting dosimetric and related information associated with the production of projection radiological images. This first edition cancels and replaces IEC/PAS 61910-1, published in 2007. It constitutes a technical revision which includes the following significant technical changes with respect to IEC/PAS 61910-1:2007:
- the previously defined three conformance levels have been restructured to two;
- the mapping between DICOM and IEC terms is explicitly described in an annex and is decoupled from the conformance level content requirements;
- and a general update to the revised contents of the DICOM RDSR definition has occurred.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§892.1650 System, X-Ray, Fluoroscopic, Image-Intensified Class 2 JAA
§892.1650 Interventional Fluoroscopic X-Ray System Class 2 OWB
§892.1650 Image-Intensified Fluoroscopic X-Ray System, Mobile Class 2 OXO
§892.1680 System, X-Ray, Stationary Class 2 KPR
§892.1680 Solid State X-Ray Imager (Flat Panel/Digital Imager) Class 2 MQB
§892.1700 Generator, High-Voltage, X-Ray, Diagnostic Class 1 IZO
§892.1720 System, X-Ray, Mobile Class 2 IZL
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
 Scott Gonzalez
  FDA/OC/OPLIA/OGPS/OGO/
  301-796-5889
  scott.gonzalez@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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