Radiodiagnostic Equipment: Regulations and Materiovigilance

Laila El Younoussi; Brahim Benaji; Mohammed Azougagh; Souad Lebbar; Lekbir El hamidi; Abdelmajid Soulaymani; Abdelrhani Mokhtari

doi:10.1051/e3sconf/202131901090

All issues

Volume 319 (2021)

E3S Web Conf., 319 (2021) 01090

References

Open Access

Issue		E3S Web Conf. Volume 319, 2021 International Congress on Health Vigilance (VIGISAN 2021)


Article Number		01090
Number of page(s)		6
DOI		https://doi.org/10.1051/e3sconf/202131901090
Published online		09 November 2021

K. Leuraud, D. Richardson, E. Cardis and al, Risk of cancer associated with low-dose radiation exposure: comparison of results between the INWORKS nuclear workers study and the A-bomb survivors study, RE Biophys. 60, 1, 23-39, (2021). [Google Scholar]
Council Directive 2013/59/EURATOM of 5 December 2013 laying down basic safety standards for health protection against the dangers arising from exposure to ionizing radiation and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom. (Official Journal of the European Union, 2014). [Google Scholar]
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Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 concerning medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Official Journal of the European Union, (2017). [Google Scholar]
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H. Baysson, C. Etard, H. J. Brisse, and M.-O. Bernier, Diagnostic radiological exposures in childhood and cancer risk: review of knowledge and perspectives, A.P, 19, 1, 64-73, (2012). [Google Scholar]
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[1] K. Leuraud, D. Richardson, E. Cardis and al, Risk of cancer associated with low-dose radiation exposure: comparison of results between the INWORKS nuclear workers study and the A-bomb survivors study, RE Biophys. 60, 1, 23-39, (2021). [Google Scholar]

[2] Council Directive 2013/59/EURATOM of 5 December 2013 laying down basic safety standards for health protection against the dangers arising from exposure to ionizing radiation and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom. (Official Journal of the European Union, 2014). [Google Scholar]

[3] B. Langen, K. Helou, and E. Forssell-Aronsson, The IRI-DICE hypothesis: ionizing radiation-induced DSBs may have a functional role for non-deterministic responses at low doses, RE. Biophys 59, 3, 349-355 (2020). [Google Scholar]

[4] D. A. Cool, K. R. Kase, and J. D. Boice, NCRP Report no.180-management of exposure to ionizing radiation: NCRP radiation protection guidance for the United States, JRP,39, 3, 966-977 (2019). [Google Scholar]

[5] Autorité de Sûreté Nucléaire, Rapport sur l’état de la sûreté nucléaire et de la radioprotection: Les utilisations médicales des rayonnements ionisants, (2017). [Google Scholar]

[6] Official Bulletin of the kingdom of Morocco, Law 84-12 relating to Medical Devices. (2013). [Google Scholar]

[7] World Health Organization, the WHO model global regulatory framework for medical devices including in vitro diagnostic medical devices, (2018) [Google Scholar]

[8] Official Bulletin of the kingdom of Morocco, Decree No. 2853 , 2854 , 2855 , 2856 relating to medical devices, [Google Scholar]

[9] Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 concerning medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Official Journal of the European Union, (2017). [Google Scholar]

[10] Council Directive 93/42 EEC of 14 June 1993 concerning medical devices”. Official Journal of the European Union, (1993). [Google Scholar]

[11] Official Bultin of the Kingdom of Morocco, Law No. 142-12 on nuclear and radiological safety and security and the establishment of the Moroccan agency for nuclear and radiological safety and security. (2014). [Google Scholar]

[12] Official Bultin of the Kingdom of Morocco, decree n° 2-97-30 of october28, 1997 taken for the application of law n ° 005-71 relating to radiation protection against ionizing radiation. (1997). [Google Scholar]

[13] Official Bulletin of the kingdom of Morocco, decree no. 2-97-132 of october 28, 1997 on the use of ionizing radiation for medical or dental purposes, (1997). [Google Scholar]

[14] C. Mangeol, Stakes and requirements of the new European regulation of medical devices, “State diploma of doctor in pharmacy, france (2019). Accessed on: march 25, 2021. Available from: https://dumas.ccsd.cnrs.fr/dumas-02140163/document [Google Scholar]

[15] M. Telle-Lamberton, Epidemiological studies on workers exposed to low doses of ionizing radiation, AMPE, 66, 2, 150-164, (2005). [Google Scholar]

[16] M.-O. Bernier, M.M Doody, M.E. Van Dyke and al, Work history and radiation protection practices in relation to cancer incidence and mortality in U.S. radiologic technologists performing nuclear medicine procedures, OEM, 75, 8, 533-561, (2018). [Google Scholar]

[17] H. Baysson, C. Etard, H. J. Brisse, and M.-O. Bernier, Diagnostic radiological exposures in childhood and cancer risk: review of knowledge and perspectives, A.P, 19, 1, 64-73, (2012). [Google Scholar]

[18] A. Kouiten, A. Harkani, G. Noulaquape, and al, VISA’ for dual ISO 9001 and ISO 13485 certification, IRBM, 37, 4, 149-155, (2016). [Google Scholar]

[19] L. Beuzelin, A. Desgranges, Q. Émile, J.-M. Prot, and G. Farges, Accompaniment to ISO 13485: 2016 certification, IRBM, 39, 2, 57-61, (2018). [Google Scholar]

[20] R. Cheng, F. Gandar, L. Zaghdoudi, and G. Farges, Helping manufacturers transition to the new ISO 14971:2019 medical device risk management standard, IRBM 42, 2, 100312, (2021). [Google Scholar]

[21] K. Leuraud, D.B. Richardson, E. Cardis and al , Ionising radiation and risk of death from leukaemia and lymphoma in radiation-monitored workers (INWORKS): an international cohort study, LH 2, 7, e276-e281, (2015). [Google Scholar]

[22] E. Cardis, M. Vrijheid, M. Blettner and al ,Risk of cancer after low doses of ionising radiation: retrospective cohort study in 15 countries, BMJ, 331, 7508, 77, (2005). [Google Scholar]

[23] M. Courtade-Saïdi, Biological effects of very low doses of ionizing radiation in occupational exposure, Morphology, 91, 294, 166-172, [Google Scholar]