Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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040
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Date of Entry 08/14/2015
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FR Recognition Number
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12-290
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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 |
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Scope/AbstractIEC 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. |
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Extent of Recognition
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§892.1650 |
System, X-Ray, Fluoroscopic, Image-Intensified
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Class 2
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JAA
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§892.1650 |
Interventional Fluoroscopic X-Ray System
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Class 2
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OWB
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§892.1650 |
Image-Intensified Fluoroscopic X-Ray System, Mobile
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Class 2
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OXO
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§892.1680 |
System, X-Ray, Stationary
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Class 2
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KPR
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§892.1680 |
Solid State X-Ray Imager (Flat Panel/Digital Imager)
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Class 2
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MQB
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§892.1700 |
Generator, High-Voltage, X-Ray, Diagnostic
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Class 1
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IZO
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§892.1720 |
System, X-Ray, Mobile
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Class 2
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IZL
|
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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. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |