DANSK DSF/PREN IEC 61223-3-7 PDF

This part of IEC 61223-3 applies to DENTAL CONE-BEAM COMPUTED TOMOGRAPHY X-RAY EQUIPMENT, hereafter also called DENTAL CBCT EQUIPMENT that conforms to IEC 60601-2-63 Ed. 1.1 NOTE 1: DENTAL CBCT EQUIPMENT is a subset of DENTAL EXTRA-ORAL X-RAY EQUIPMENT. NOTE 2: DENTAL EXTRA-ORAL X- RAY EQUIPMENT may provide one or more of PANORAMIC, CEPHALOMETRIC, tomosynthesis and DENTAL CBCT imaging modalities, all of which are in the scope of the IEC 60601-2-63 safety standard. This standard 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 standard are minimal requirements. The manufacturer may establish criteria for the tests described here that exceed the levels contained in this standard. 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 standard also contains requirements for the ACCOMPANYING DOCUMENTS associated with ACCEPTANCE AND CONSTANCY TESTING of the DENTAL CBCT EQUIPMENT.