Radiodiagnostic Equipment: Regulations and Materiovigilance
The use of medical devices (MDs) in the field of medical imaging has always been governed by rigorous regulations, in particular the authorizations and compliance of radiological installations and premises in view of the risks generated by the ionizing radiation produced by these MDs. The regulatory...
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EDP Sciences
2021
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oai:doaj.org-article:51fa23650bc84897ac595b18c51b3f7d2021-11-12T11:44:08ZRadiodiagnostic Equipment: Regulations and Materiovigilance2267-124210.1051/e3sconf/202131901090https://doaj.org/article/51fa23650bc84897ac595b18c51b3f7d2021-01-01T00:00:00Zhttps://www.e3s-conferences.org/articles/e3sconf/pdf/2021/95/e3sconf_vigisan_01090.pdfhttps://doaj.org/toc/2267-1242The use of medical devices (MDs) in the field of medical imaging has always been governed by rigorous regulations, in particular the authorizations and compliance of radiological installations and premises in view of the risks generated by the ionizing radiation produced by these MDs. The regulatory bases that deal with equipment emitting ionizing radiation are diversified between those specific to the protection of the public and users of ionizing radiation and those relating to medical devices. In addition, radio-diagnostic equipment must provide all the guarantees in terms of the balance between benefits and risks. Although radiation protection is essential, materiovigilance is one of the key elements of technological monitoring and surveillance of the risks that may result from the use of these medical devices after they have been placed on the market. The Moroccan legislation has a legal arsenal in accordance with the model of the World Health Organization’s global regulatory framework for medical devices. It outlines regulations and adheres to international guidelines in the field of vigilance against ionizing radiation. However, it is necessary to move on to the specification of procedures in order to remove any ambiguity.El Younoussi LailaBenaji BrahimAzougagh MohammedLebbar SouadEl hamidi LekbirSoulaymani AbdelmajidMokhtari AbdelrhaniEDP Sciencesarticlemedical deviceionizing radiationradio-diagnostic equipmentmateriovigilanceregulationsEnvironmental sciencesGE1-350ENFRE3S Web of Conferences, Vol 319, p 01090 (2021) |
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DOAJ |
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DOAJ |
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EN FR |
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medical device ionizing radiation radio-diagnostic equipment materiovigilance regulations Environmental sciences GE1-350 |
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medical device ionizing radiation radio-diagnostic equipment materiovigilance regulations Environmental sciences GE1-350 El Younoussi Laila Benaji Brahim Azougagh Mohammed Lebbar Souad El hamidi Lekbir Soulaymani Abdelmajid Mokhtari Abdelrhani Radiodiagnostic Equipment: Regulations and Materiovigilance |
| description |
The use of medical devices (MDs) in the field of medical imaging has always been governed by rigorous regulations, in particular the authorizations and compliance of radiological installations and premises in view of the risks generated by the ionizing radiation produced by these MDs. The regulatory bases that deal with equipment emitting ionizing radiation are diversified between those specific to the protection of the public and users of ionizing radiation and those relating to medical devices. In addition, radio-diagnostic equipment must provide all the guarantees in terms of the balance between benefits and risks. Although radiation protection is essential, materiovigilance is one of the key elements of technological monitoring and surveillance of the risks that may result from the use of these medical devices after they have been placed on the market. The Moroccan legislation has a legal arsenal in accordance with the model of the World Health Organization’s global regulatory framework for medical devices. It outlines regulations and adheres to international guidelines in the field of vigilance against ionizing radiation. However, it is necessary to move on to the specification of procedures in order to remove any ambiguity. |
| format |
article |
| author |
El Younoussi Laila Benaji Brahim Azougagh Mohammed Lebbar Souad El hamidi Lekbir Soulaymani Abdelmajid Mokhtari Abdelrhani |
| author_facet |
El Younoussi Laila Benaji Brahim Azougagh Mohammed Lebbar Souad El hamidi Lekbir Soulaymani Abdelmajid Mokhtari Abdelrhani |
| author_sort |
El Younoussi Laila |
| title |
Radiodiagnostic Equipment: Regulations and Materiovigilance |
| title_short |
Radiodiagnostic Equipment: Regulations and Materiovigilance |
| title_full |
Radiodiagnostic Equipment: Regulations and Materiovigilance |
| title_fullStr |
Radiodiagnostic Equipment: Regulations and Materiovigilance |
| title_full_unstemmed |
Radiodiagnostic Equipment: Regulations and Materiovigilance |
| title_sort |
radiodiagnostic equipment: regulations and materiovigilance |
| publisher |
EDP Sciences |
| publishDate |
2021 |
| url |
https://doaj.org/article/51fa23650bc84897ac595b18c51b3f7d |
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AT elyounoussilaila radiodiagnosticequipmentregulationsandmateriovigilance AT benajibrahim radiodiagnosticequipmentregulationsandmateriovigilance AT azougaghmohammed radiodiagnosticequipmentregulationsandmateriovigilance AT lebbarsouad radiodiagnosticequipmentregulationsandmateriovigilance AT elhamidilekbir radiodiagnosticequipmentregulationsandmateriovigilance AT soulaymaniabdelmajid radiodiagnosticequipmentregulationsandmateriovigilance AT mokhtariabdelrhani radiodiagnosticequipmentregulationsandmateriovigilance |
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