Medical electrical equipment – Radiation dose documentation – Part 1: Equipment for radiography and radioscopy
|Publication Date:||8 May 2008|
|ICS Code (Radiographic equipment):||11.040.50|
This Publicly Available Specification (PAS) applies to MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. The scope of this document encompasses all forms of projection radiographic equipment incorporating means for measuring or calculating dose related quantities and capable of producing DICOM compatible images and/or reports. This document provides specific units and quantities. It does not apply for: - dental radiography and radioscopy; - mammography; - computed tomography. NOTE - A system that uses a film-screen image receptor may conform to this PAS if it can produce reports confirming to a level of this document. The intent is to develop and publish similar documents for all X-ray imaging modalities capable of producing DICOM compatible images and/or reports. Parallel documents are currently under development for mammography and computed tomography. This document defines data storage formats. It does not put specific requirements on the accuracy of the data. The data formats are specified such that the numerical uncertainty attributable to the stored format is likely to be small compared to other data uncertainties. This document does not present any requirements on the form of display of such information to operators or other individuals.