EN IEC 62985:2019

Methods for calculating size specific dose estimates (SSDE) on computed tomography EN IEC 62985:2019

Publication date:   Feb 14, 2020

General information

60.60 Standard published   Nov 1, 2019

CENELEC

CLC/TC 62 Electrical equipment in medical practice

European Norm

11.040.50   Radiographic equipment

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Scope

IEC 62985:2019 applies to

– 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 (D<sub>W</sub>), and D<sub>W</sub>(z), where z represents a specific longitudinal position of the scanned object.

This document provides a method of determining a reference WATER EQUIVALENT DIAMETER, D<sub>W,REF</sub>(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, D<sub>W,IMP</sub>(z), is tested and validated against D<sub>W,REF</sub>(z) using the TEST OBJECTS and methods defined within this document. This document also describes the methods for calculating SSDE and D<sub>W</sub>, which represent the average values of SSDE(z) and D<sub>W</sub>(z) over the RECONSTRUCTION LENGTH.

Life cycle

NOW

PUBLISHED
EN IEC 62985:2019
60.60 Standard published
Nov 1, 2019

CORRIGENDA / AMENDMENTS

PUBLISHED
EN IEC 62985:2019/AC:2022-07