This is because, for electrical devices used for non‑medical purposes, there is no equivalent of the “CE” marking that is mandatory for medical devices, certifying conformity with several European standards that cover various aspects, including radiation protection. Furthermore, experience feedback shows that a large number of devices do not have a certificate of conformity to the standards applicable in France. These standards have been mandatory for many years now, but some of their requirements have become partly obsolete or inapplicable due to the lack of recent revisions. On the basis of the work done in collaboration with the Electrical Certification and Testing Entity (LCIE), the Alternative Energies and Atomic Energy Commission (CEA) and IRSN, draft texts have been produced with the aim of defining minimum radiation protection requirements for the design of these devices and an informal technical consultation of the stakeholders (suppliers, French and foreign manufacturers and the principal users) was conducted in 2015. The various contributions are currently being analysed with the assistance of IRSN and the reference players (CEA and LCIE). The conclusions of this work will be taken into account to adapt the regulatory framework and subject the supply of electrical devices emitting ionising radiation to licensing, in the same way as for radioactive sources. Since 2021, ASN has thus been conducting work to characterise the advantages, drawbacks and the feasibility of various regulatory provisions for regulating, on the basis of appropriate technical baselines (work conducted with IRSN in particular), the design of industrial radiography devices. The discussions with the General Directorate for Labour (DGT) on the various options are continuing and highlight the need to strengthen their link with the existing European framework. 2.3.2 The protection of ionising radiation sources against malicious acts Although the safety and radiation protection measures provided for by the regulations guarantee a certain degree of protection of ionising radiation sources against the risk of malicious acts, they cannot be considered sufficient. Reinforcing the oversight of protection against malicious acts targeting sealed radioactive sources has therefore been encouraged by the IAEA, which published a Code of Conduct on the Safety and Security of Radioactive Sources, approved in 2003, supplemented in 2012 by two implementation guides in the Nuclear Security Series relative to the security of radioactive sources and the security of radioactive material transport. As of 2004, France confirmed to the IAEA that it was working on the application of the guidelines set out in this Code. The organisation adopted for the oversight of protection against malicious acts Measures implemented to ensure radiation protection, safety, and protection against malicious acts have many interfaces. Generally speaking, ASN’s counterparts in other countries are responsible for oversight in these three areas (see Table 2 in chapter 2). In France, the protection against malicious acts concerning nuclear materials, particularly those used in certain facilities termed “of vital importance” because they contribute to productions or services that are essential for the functioning of the country, is coordinated by a service under the authority of the Defence and Security High Official (HFDS) of the Ministry responsible for energy. GRAPH Breakdown of high‑activity sealed sources according to their category and their oversight authority for protection against malicious acts 5 0 10% 20% 30% 40% 50% 60% 70% Ministry of Defence Defence and Security High Official (HFDS) ASN ASN and HFDS Category A Category C Category B The sources in category A of the Public Health Code correspond to the IAEA category 1 sources. The Public Health Code category B sources correspond to: – the IAEA category 2 sources, – the IAEA category 3 sources contained in a mobile or portable device. The Public Health Code category C sources correspond to the IAEA category 3 sources not contained in a mobile or portable device. Radioactive sources have been classified by the International Atomic Energy Agency (IAEA) since 2011 on the basis of predetermined exposure scenarios, in five categories from 1 to 5, according to their ability to create early harmful effects on human health if they are not managed safely and securely. Category‑1 sources are considered extremely dangerous while those in category 5 are considered very unlikely to be dangerous. Sources in categories 1 to 3 are considered dangerous for humans to varying degrees. This categorisation is based solely on the capacity of the sources to produce deterministic effects in certain exposure scenarios and must not under any circumstances be considered as proof that there is no danger in exposure to a category 4 or 5 source, as such exposure could cause stochastic effects in the longer term. The principles of justification and optimisation must therefore be respected in all cases. This IAEA work has been taken up in an Appendix to the Public Health Code amended by Decree 2018‑434 establishing various provisions in the nuclear field. Nevertheless, the IAEA categories 4 and 5 have been grouped together in category D of this Code. CATEGORISATION OF RADIOACTIVE SOURCES 250 ASN Report on the state of nuclear safety and radiation protection in France in 2023 • 08 • Sources of ionising radiation and their industrial, veterinary and research applications
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