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  • IEC
    IEC 61223-3-7 Ed. 1.0 b:2021 Evaluation and routine testing in medical imaging departments - Part 3-7: Acceptance and constancy tests - Imaging performance of X-ray equipment for dental cone beam computed tomography
    Edition: 2021
    $818.42
    / user per year

Content Description

IEC 61223-3-7:2021 applies to DENTAL CONE-BEAM COMPUTED TOMOGRAPHY X-RAY EQUIPMENT, hereafter also called DENTAL CBCT EQUIPMENT, that conforms to IEC 60601-2-63:2012 and IEC 60601-2-63:2012/AMD1:2017.
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 DENTAL CBCT EQUIPMENT.
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.
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 DENTAL CBCT EQUIPMENT 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.

About IEC

The IEC is a global, not-for-profit membership organization, whose work underpins quality infrastructure and international trade in electrical and electronic goods. The IEC facilitates technical innovation, affordable infrastructure development, efficient and sustainable energy access, smart urbanization and transportation systems, climate change mitigation, and increases the safety of people and the environment.

 

The IEC brings together ~170 countries and provides a global, neutral and independent standardization and conformity assessment platform for 30 000 experts globally. It administers 4 Conformity assessment systems whose members certify that devices, systems, installations, services and people work as required.

 

The IEC publishes around 10 000 IEC International Standards which together with conformity assessment provide the technical framework that allows governments to build national quality infrastructure and companies of all sizes to buy and sell consistently safe and reliable products in most countries of the world. IEC International Standards serve as the basis for risk and quality management and are used in testing and certification to verify that manufacturer promises are kept.
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