BS EN IEC 61223-3-7:2021 - Page 2

Evaluation and routine testing in medical imaging departments. Acceptance and constancy tests. Imaging performance of X-ray equipment for dental cone beam computed tomography | Status: Current

1 Scope and object This part of IEC 61223 applies to dental cone-beam computed tomography x-ray equipment, hereafter also called dentalCBCTequipment, that conforms to IEC 60601‑2‑63:2012+AMD1:2017+AMD2:2021.

NOTE 1 DentalCBCTequipment is a subset of Dental extra-oral X-ray equipment.

NOTE 2 Dental extra-oral x-ray equipment can provide one or more of panoramic, cephalometric, tomosynthesis and DentalCBCT imaging modalities, all of which are in the scope of the IEC 60601‑2‑63 basic safety and performance standard.

This document applies to acceptance tests and constancy tests on dental cone-beam computed tomography x-ray equipment. The aim of acceptance tests is to verify compliance of the installation or major service action with specifications affecting the image quality, radiation output and patient positioning. The requirements specified in this document are minimal requirements. The manufacturer can establish criteria for the tests described here that exceed the levels contained in this document. Constancy tests are performed to ensure that the functional performance of ME equipment meets established criteria and to enable the early recognition of changes in the properties of components of the ME equipment, and to verify compliance with specifications affecting the image quality, radiation output and patient positioning. This document also contains requirements for the accompanying documents associated with acceptance and constancy testing of the dentalCBCTequipment. This document does not apply to:

• — aspects of thermal, EMD (electromagnetic disturbances), mechanical and electrical safety;
• — aspects of mechanical, electrical and software performance, unless they are essential for performing the acceptance tests and constancy tests, and directly affect image quality, radiation output and patient positioning.

NOTE 3 Such aspects are generally addressed by IEC 60601‑1 (all parts).

Equipment in the scope of IEC 61223‑3‑5 is excluded from the scope of this document. Dental extra-oral x-ray equipment can provide modalities which are in the scope of IEC 61223‑3‑4. In this case, the respective clauses of the IEC 61223‑3‑4 apply. The object of this document is to establish:

• — the essential parameters which describe the performance of dentalCBCTequipment with regard to the image quality, radiation output and patient positioning;
• — methods of testing and whether measured quantities related to those parameters comply with the specified requirements.

These methods rely on non-invasive measurements performed once the installation or a major service action is completed.