Medical electrical equipment – Radiation dose documentation – Part 1: Radiation dose structured reports for radiography and radioscopy
|Publication Date:||1 September 2014|
|ICS Code (Radiographic equipment):||11.040.50|
This International Standard applies to RADIATION DOSE STRUCTURED REPORTS (RDSR) produced by X-RAY EQUIPMENT that falls within the scope of IEC 60601-2-43:2010 or IEC 60601-2- 54:2009.
NOTE 1 The intent is to develop and publish similar documents for other X-ray imaging modalities capable of producing RDSRs.
NOTE 2 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.
NOTE 3 The data formats are specified such that the numerical uncertainty attributable to the format is likely to be small compared to other data uncertainties.
NOTE 4 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.
NOTE 5 The data fields and report structure are intended to facilitate the collection of dosimetric data useful for: management of procedures delivering significant dose, facility quality programs, establishment of reference levels, education.
NOTE 6 A public structure facilitates data analysis by any appropriate individual or organization.