IEC 62985:2019/COR1:2022
(Corrigendum)Corrigendum 1 - Methods for calculating size specific dose estimates (SSDE) for computed tomography
Corrigendum 1 - Methods for calculating size specific dose estimates (SSDE) for computed tomography
Corrigendum 1 - Méthodes de calcul de l’estimateur de dose morphologique (SSDE) en tomodensitométrie
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IEC 62985:2019/COR1:2022 – 1 –
IEC 2022
INTERNATIONAL ELECTROTECHNICAL COMMISSION
COMMISSION ÉLECTROTECHNIQUE INTERNATIONALE
____________
IEC 62985 IEC 62985
Edition 1.0 2019-09 Édition 1.0 2019-09
Methods for calculating size specific dose Méthodes de calcul de l’estimateur de dose
estimates (SSDE) for computed tomography morphologique (SSDE) en tomodensitométrie
CO RRI G E NDUM 1
3.3 WATER EQUIVALENT DIAMETER AT 3.3 DIAMETRE EQUIVALENT EAU DANS LA
LONGITUDINAL POSITION Z POSITION LONGITUDINALE Z
Replace the last sentence of the existing Remplacer la dernière phrase de la
Note 2 to entry with the following: Note 2 à l’article existante par ce qui suit:
However, validation of the D (z) Cependant, la validation du D (z)
W,IMP W,IMP
implemented by the RDIMS device can appliqué par le dispositif RDIMS peut
...
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IEC 62220-2-1:2023 describes the performance metrics associated with DUAL-ENERGY IMAGING capable DIGITAL X-RAY IMAGING DEVICES meant for medical applications and specifies the methods for their determination. These metrics can be used to analyse TISSUE-SUBTRACTED IMAGES and to evaluate dose performance, noise characteristics, and tissue-subtraction efficacy of DIGITAL X-RAY IMAGING DEVICES. The described methods indicate the procedures to obtain MULTI-SPECTRAL PRIMARY DATA and to compute their derived TISSUE-SUBTRACTED IMAGES.
The intended users of this document are MANUFACTURERS and well-equipped test laboratories. This document is restricted to DIGITAL X-RAY IMAGING DEVICES that are used for single or multiple exposure dual-energy radiographic imaging based on, for example, CR systems, direct and indirect flat panel-detector based systems.
This document excludes and is not applicable to:
– DIGITAL X-RAY IMAGING DEVICES intended to be used in mammography or in dental RADIOGRAPHY;
– slot scanning DIGITAL X-RAY IMAGING DEVICES;
– COMPUTED TOMOGRAPHY or CONE-BEAM COMPUTED TOMOGRAPHY;
– photon-energy discriminating devices such as photon counting X-RAY IMAGING DEVICES;
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IEC 60601-2-43:2022 is available as IEC 60601-2-43:2022 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-43:2022 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of both FIXED and MOBILE X RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, hereafter referred to as INTERVENTIONAL X-RAY EQUIPMENT. Its scope excludes, in particular:
- equipment for RADIOTHERAPY;
- equipment for COMPUTED TOMOGRAPHY;
- ACCESSORIES intended to be introduced into the PATIENT;
- mammographic X RAY EQUIPMENT;
- dental X RAY EQUIPMENT.
INTERVENTIONAL X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, which does not include a PATIENT SUPPORT as part of the system, is exempt from the PATIENT SUPPORT provisions of this document.
If a clause or subclause is specifically intended to be applicable to INTERVENTIONAL X-RAY EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to INTERVENTIONAL X-RAY EQUIPMENT and to ME SYSTEMS, as relevant.
IEC 60601-2-54 applies only with regards to the cited subclauses; non-cited subclauses of IEC 60601-2-54 do not apply.
IEC 60601-2-43:2022 cancels and replaces the second edition published in 2010, Amendment 1:2017 and Amendment 2:2019. This edition constitutes a technical revision.
This edition includes editorial and technical changes to reflect the IEC 60601-1:2005/AMD2:2020 and IEC 60601-2-54:2022. It also contains corrections and technical improvements. Significant technical changes with respect to the previous edition are as follows:
a) a new specific term DOSIMETER is introduced to replace the general term DOSEMETER as in IEC 60601-2-54:2022;
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c) the collateral standards IEC 60601-1-11:2015, IEC 60601-1-11:2015/AMD1:2020, IEC 60601-1-12:2014 and IEC 60601-1-12:2014/AMD1:2020 are applicable if MANUFACTURER so declares;
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IEC 60806:2022 cancels and replaces the first edition published in 1984. This edition constitutes a technical revision.
This edition includes the following significant technical change with respect to the previous edition:
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a) a new specific term DOSIMETER is introduced to replace the general term DOSEMETER;
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c) the collateral standards IEC 60601-1-11:2015, IEC 60601-1-11:2015/AMD1:2020, IEC 60601-1-12:2014 and IEC 60601-1-12:2014/AMD1:2020 are applicable if MANUFACTURER so declares;
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e) to adopt changes which are introduced with respect to indicator lights in 7.8.1 of the IEC 60601-1:2005/AMD2:2020 clarification of requirements is provided to avoid conflicts with requirements of indicator lights stipulated for X-RAY EQUIPMENT;
f) explanation of the term ESSENTIAL PERFORMANCE is provided in Annex AA to emphasize the performance of the clinical function under NORMAL and SINGLE FAULT CONDITIONS. CONDITIONS.
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This document does not apply to:
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