RadSyncMed Quality Framework

Our quality framework is developed based on internationally recognized guidelines, standards, and scientific references for mammography quality assurance.

IEC 60601-2-45:2022

Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices

IEC 60601-2-54:2022

Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

IEC 61223-3-6:2020

Evaluation and routine testing in medical imaging departments - Part 3-6: Acceptance and constancy tests - Imaging performance of mammographic X-ray equipment used in a mammographic tomosynthesis mode of operation

European Reference Organisation for Quality Assured Breast Screening and Diagnostic Services

EUREF, the European Reference Organisation for Quality Assured Breast Screening and Diagnostic Services, is a pan European organisation, widely drawn from different Member States and is operated on a non-profit making basis for over 30 years. EUREF’s aim is to promote en ensure consistent high-quality breast screening and diagnostic services in Europe.

Council Directive 2013/59/Euratom

Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom

The Authority for Nuclear Safety and Radiation Protection (ANVS)

The Authority for Nuclear Safety and Radiation Protection (ANVS) ensures that the highest standards of nuclear safety and radiation protection are met in the Netherlands. The ANVS performs that role by laying down rules, issuing licences, ensuring that licence-holders abide by the conditions and, if the need arises, taking enforcement action.