– CT SCANNERS that are able to display and report CTDIVOL in accordance with
IEC 60601-2-44, and
– RADIATION dose index monitoring software (RDIMS)
for the purpose of calculating, displaying and recording the SIZE SPECIFIC DOSE ESTIMATE (SSDE) and its associated components.
Specifically, this document provides standardized methods and requirements for calculating, displaying, or recording of SSDE, SSDE(z), WATER EQUIVALENT DIAMETER (DW), and DW(z), where z represents a specific longitudinal position of the scanned object.
This document provides a method of determining a reference WATER EQUIVALENT DIAMETER, DW,REF(z), using CT scans of two cylindrical water PHANTOMS and one or more anthropomorphic PHANTOM(S), which conform to the specifications defined in this document. The method of calculating the WATER EQUIVALENT DIAMETER that is implemented by the MANUFACTURER, DW,IMP(z), is tested and validated against DW,REF(z) using the TEST OBJECTS and methods defined within this document. This document also describes the methods for calculating SSDE and DW, which represent the average values of SSDE(z) and DW(z) over the RECONSTRUCTION LENGTH.
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EN 60601-1-3:2008 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
EN 60601-1:2006 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN 60601-1:2006/A1:2013 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN 60601-1-3:2008 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
EN 60601-1:2006 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN 60601-1:2006/A1:2013 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN 60601-2-44:2009 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
IEC/TR 60788:2004 Medical electrical equipment - Glossary of defined terms