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.