ASN Report 2022

4. Manufacturers and distributors of radioactive sources and their oversight by ASN 4.1 The issues and challenges The aim of ASN oversight of the suppliers of radioactive sources or devices containing them is to ensure the radiation protection of the future users. It is based on the technical examination of the devices and sources with respect to operating safety and radiation protection conditions during future utilisation and maintenance. It also allows the tracking of source transfers and the recovery and disposal of disused or end-of-life sources. Source suppliers also play a teaching role with respect to users. At present, only the suppliers of sealed radioactive sources (or devices containing them) and of unsealed radioactive sources are regulated in France (see point 2.3.1). ASN lists around 115 suppliers with safety-significant business, including 36 low and medium-energy cyclotrons which are currently licensed under the Public Health Code in France. Cyclotrons are used to produce positron-emitting radionuclides in unsealed sources (primarily fluorine-18). These radionuclides are used either for medical applications, especially in vivo diagnosis, or in clinical trial protocols (human subject research), or for research activities. 4.2 Cyclotrons Operation As at 31 December 2022, 4 cyclotrons were “on standby” and 32 cyclotrons were in service. Among the 32 cyclotrons in routine operation, 25 are used to produce radiopharmaceuticals intended at least for in vivo diagnosis, sometimes with medical or nonmedical research as an additional end-purpose, five produce radionuclides for medical or non-medical research purposes, and two produce radionuclides exclusively for non-medical research. GRAPH Trends in the number of events reported to ASN in the research sector from 2013 to 2022 12 0 5 10 15 20 25 30 35 2022 2021 2020 2019 2018 2017 2016 2015 2014 2013 Number rated level 0 Number rated level 1 Number rated level 2 GRAPH Distribution over the French territory, according to the competent ASN entity, of licensed or registered facilities using sources of ionising radiation in the research sector in 2022 11 Number of licenses and registrations 0 20 40 60 80 100 120 140 160 180 200 220 Dijon Caen DTS Orléans Strasbourg/ Châlons Lille Nantes Lyon Bordeaux Marseille Paris Licenses Registrations 10 14 17 19 25 25 41 67 81 93 173 10 25 15 8 1 3 1 3 4 260 ASN Report on the state of nuclear safety and radiation protection in France in 2022 • 08 • Sources of ionising radiation and their industrial, veterinary and research applications 08

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