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HomeGuidance on the implementation of Council Directive 2013/59/Euratom Requirements for Medical Equipment with Respect to Monitoring and Control of Patient Radiation Exposures
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The Directive 2013/59/Euratom addresses medical ionising radiations applications through various aspects. The articles 60.3 and 58(b) specifically define requirements for fluoroscopy, CT, and radiodiagnostic equipment (article 60.3(a)), radiotherapy equipment (article 60.3.(b)) and interventional radiology equipment (article 60.3(c)). Article 60.3(d/e/f) stipulates transversal requirements concerning equipment used in medical ionising radiation applications to control, record, and report patient radiation exposure. This guidance provides best-practice recommendations and technical guidance for the implementation of the articles 60.3 and 58(b). It covers diagnostic and interventional radiology, nuclear medicine and radiotherapy and takes into account the results of the ad hoc survey that has been performed in the frame of the study, as well as the most recent international recommendations in this area. The survey highlighted the discrepancies across Europe as regards to the compliance with these articles, varying from a near-full (articles 60.3(a)), to limited compliance (article 58(b)) depending on the challenges faced by local stakeholders. The present guidance includes recommendations related to articles 60.3(a) to (f) and 58(b).
- Published:
- Corporate author(s): Directorate-General for Energy (European Commission) , NucAdvisor/EFOMP
- Personal author(s): Mario, N ; Andersson, J ; Lopez Medina, A ; Visvikis, D ; Kolmayer, A ; Frija, G
- Themes: Nuclear energy and safety
- Subject: ionising radiation , medical device , medical diagnosis , medical research , patient safety , radiation protection , therapeutics
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| ISSN 2315-2826 | ISBN 978-92-68-25394-6 | DOI 10.2833/5894651 | Catalogue number MJ-01-25-054-EN-N |
- Released on EU publications website:
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