DIN EN IEC 61223-3-7:2023-11: Evaluation and routine testing in medical imaging departments - Pt. 3-7: Acceptance and constancy tests - Imaging performance of X-ray equipment for dental cone beam computed tomography (IEC 61223-3-7:2021); German version EN IEC 61223-3-7:2022

This document was prepared by Subcommittee SC 62B "Diagnostic imaging equipment" of the International Electrotechnical Commission (IEC). The responsible national standardization body is Working Committee NA 080-00-06 AA "Imaging systems" in the DIN Standards Committee Radiology (NAR). This part of IEC 61223 is applicable to dental X-ray equipment for dental digital volume tomography, hereinafter also referred to as dental DVT equipment, that conform to IEC 60601-2-63:2012+AMD1:2017+AMD2:2021. This document is applicable to acceptance tests and constancy tests on dental X-ray equipment for dental digital volume tomography. The aim of the acceptance tests is to check the conformity of the installation or essential maintenance measure with specifications that affect image quality, radiation yield and patient positioning. The requirements specified in this document are minimum requirements. The manufacturer may specify criteria for the tests described here that exceed the level contained in this document. Constancy tests are performed to ensure that the performance of medical electrical equipment meets the specified criteria and to detect changes in the characteristics of the medical electrical equipment at an early stage and to check conformity with specifications affecting image quality, radiation output and patient positioning. This document also contains requirements for the accompanying documents in connection with the acceptance and constancy testing of dental CBCT equipment. This document does not apply to: - aspects of thermal, EMD (electromagnetic interference), mechanical and electrical safety; - aspects of mechanical, electrical and software behavior, unless these are essential for conducting the acceptance tests and constancy tests and directly affect image quality, radiation output and patient positioning. Equipment within the scope of IEC 61223-3-5 is generally excluded from the scope of this document. Dental extraoral X-ray equipment may provide modalities included in the scope of IEC 61223-3-4. In this case, the relevant clauses of the IEC 61223-3-4 series of standards apply. The purpose of this document is to specify: - the essential parameters describing the performance of dental CBCT equipment in terms of image quality, radiation efficiency and patient positioning; - the procedures for checking whether the measured quantities in relation to these parameters comply with the specified requirements. These procedures are based on non-invasive measurements carried out once installation or a major maintenance operation has been completed.