IEC 61910-1 Edition 1.0 2014-09

Standard Organization:

IEC 61910-1 Edition 1.0 2014-09
Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy

Recognition Date2015-08-14
Recognition List040
Recognition Number12-290
Extent Complete standard
Standards Orgs IEC International Electrotechnical Commission http://www.iec.ch/
STG Radiology
FDA Tech  Scott Gonzalez   FDA/OMPT/CDRH/OIR/DRH/DXRS/   301-796-5889   scott.gonzalez@fda.hhs.gov

Rationale:

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Scope:

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.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§892.1720 System, X-Ray, Mobile Class 2 IZL
§892.1700 Generator, High-Voltage, X-Ray, Diagnostic Class 1 IZO
§892.1680 Solid State X-Ray Imager (Flat Panel/Digital Imager) Class 2 MQB
§892.1680 System, X-Ray, Stationary Class 2 KPR
§892.1650 Image-Intensified Fluoroscopic X-Ray System, Mobile Class 2 OXO
§892.1650 Interventional Fluoroscopic X-Ray System Class 2 OWB
§892.1650 System, X-Ray, Fluoroscopic, Image-Intensified Class 2 JAA

FDA Guidance:

There is no relevant guidance developed at this time.

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