Detailed information on acceptance and constancy testing In order to meet the high requirements of diagnostic reporting, a number of basic principles have been developed in Germany to ensure that the image display systems (AAS) used meet these high quality standards.
At the same time, control bodies have been appointed to ensure that the framework conditions created for quality assurance are also implemented.

ACCEPTANCE AND CONSTANCY TEST

To ensure proper installation and configuration of the AOPD, an acceptance test of the AOPD must be carried out by the manufacturer or supplier in accordance with X-ray Ordinance (RöV) §16.
Among other things, this involves checking whether the image display unit (AOPD) is controlled at the correct resolution and whether the required reference values are complied with in accordance with the declared room class and the diagnostic method.
Subsequently, visual or metrological tests, so-called constancy tests, must be carried out at regular, defined intervals.
This is carried out by expert personnel of the operator or by a service provider such as Rein Medical GmbH.
Optional: we will be happy to inform you about training opportunities at your / our premises.

STANDARDS, GUIDELINES, ETC.

There are different catalogs of requirements for ESPE.
The following regulations must be taken into account for quality assurance: DIN 6868-157:2014-11, which regulates the performance of the acceptance test of the ESPE, is a German standard from November 2014 which replaces DIN-V 6868-57:2001-02 for initial commissioning and new acceptance tests of diagnostic monitors, supplements it with requirements for the constancy test and adapts it to the state of the art.
An important part of quality assurance is the consideration of environmental conditions.
It is not only direct and indirect light sources that must be taken into account during the acceptance test.
In contrast to DIN-V 6868-57, which is no longer permitted for new acceptance tests as of 01.05.2015, there is no longer a distinction between categories (Cat. A / Cat. B. / mammography) but a division into room classes with corresponding requirements (see table) These room classes (RK 1-6) are divided into – AAS with diagnostic quality – AAS with viewing quality   An AAS is made up of several components (hardware and software), which are documented during the acceptance test.
If one of these components is replaced or the software version of the PACS or operating system is changed, a partial acceptance test / comparison measurement must be carried out to ensure that the change does not affect the image quality.
In addition, the scope of application in dentistry is now also regulated in DIN 6868-157.
For the acceptance test, it is necessary, among other things, that the test images specified in DIN 6868-157 can be displayed from the application software (in most cases your PACS software) in the native resolution of the BWG.
Since a negative influence on the display of the test images when using different software cannot generally be ruled out, the manufacturer or supplier must either carry out the tests in the application software during the acceptance test or ensure an identical display, e.g. by means of a comparative measurement between the application and QA software.
This serves the uniform approach of DIN 6868-157 to include all components that can have a quality-relevant influence on the quality of the findings in quality assurance.
The Quality Assurance Guideline (QA Guideline) is currently being revised due to the changes introduced by DIN 6868-157.
It regulates the practical implementation of the constancy test in accordance with DIN-V 6868-57, which applies to monitors accepted before May 1, 2015, as well as the constancy test in accordance with DIN 6868-157 in the revised version.

A LOOK AT OTHER COUNTRIES

Even though Germany plays a leading role in the implementation and design of quality assurance at national level in Europe, there are other countries that also call for the implementation of quality assurance of BWG.
The “American Association of Physicists in Medicine (AAPM)” and the report of “Task Group 18 (TG18)”, which is part of the AAPM, can be seen as one of the most important pioneers in quality assurance.
The “Quality assurance guideline for medical imaging display systems” of the “Japan Industries Association of Radiological Systems Standards (JESRA)” is also strongly based on this description of quality assurance.
Other countries that have also implemented quality assurance are usually based on the AAPM or the DIN V 6868-57 template, such as the Swiss “Directive R – 08 – 06” issued by the Federal Office of Public Health.

MINIMUM REQUIREMENTS FOR PICTURE DISPLAY DEVICES ACCORDING TO DIN 6868-157

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