ASN Report 2023

IONISOS IRRADIATOR The company Ionisos operates two industrial ionisation installations on the sites of Pouzauges (Vendée département) and Sablé‑sur‑Sarthe (Sarthe département) respectively, which use high-activity cobalt-60 sealed radioactive sources. These installations constitute Basic Nuclear Installations (BNIs) 146 and 154 respectively. The gamma radiation emitted is used for sterilisation purposes or to reinforce (by cross-linking) the technical properties of certain polymers, by exposing the products to be ionised (single-use medical equipment, packaging, raw materials and finished products for the pharmaceutical and cosmetic industries, packing films) for a pre-determined length of time. Each installation comprises a pool for underwater storage of the radioactive sources, surmounted by a bunker in which the ionisation operations are performed, premises for storing the products before and after treatment, and offices and technical rooms. ASN considers that the safety of operation of the Pouzauges and Sablé‑sur‑Sarthe irradiators has regressed slightly compared with the preceding years. ASN thus expects Ionisos to reinforce its safety management and skills management, and to show greater rigour in the inspections and verifications of activities and safety-important equipment. ASN noted the simultaneous departure of the safety manager and the group safety engineer, and the departure of the Pouzauges site manager, which constitutes a situation requiring vigilance in terms of organisation. Two modifications concerning the reference “waste” zoning were authorized in May 2023 on each of the Pouzauges and Sablé‑sur‑Sarthe facilities. An exercise on implementation of the “Organisation of the Civil Security Response relative to the Transport of Radioactive Materials” (Orsec-TMR) of the Vendée département was held on the Ionisos Pouzauges site on 12 October 2023. The installations and activities to regulate comprise: • Basic Nuclear Installations: •the Ionisos irradiator in Pouzauges, • the Ionisos irradiator in Sablé-sur-Sarthe; • small-scale nuclear activities in the medical sector: • 7 external-beam radiotherapy departments, •2 brachytherapy units, •11 nuclear medicine departments, • 39 centres performing fluoroscopy-guided interventional procedures, • 56 computed tomography scanners, • some 2,500 medical and dental radiology devices; • small-scale nuclear activities in the industrial, veterinary and research sectors: •1 cyclotron, • 29 industrial radiography companies, including 7 performing gamma radiography, • 19 research units, • about 400 users of industrial equipment; • activities associated with the transport of radioactive substances; • ASN-approved laboratories and organisations: • 8 organisations approved for measuring radon, •1 head-office of a laboratory approved for environmental radioactivity measurements. Chapter 7 p. 204 Chapter 8 p. 240 Chapter 9 p. 270 Pays de la Loire REGION The Nantes division regulates nuclear safety, radiation protection and the transport of radioactive substances in the 5 départements of the Pays de la Loire region. In 2023, ASN carried out 45 inspections, comprising three in the facilities of the company Ionisos (in the municipalities of Pouzauges and Sablé‑sur‑Sarthe), one concerning approved organisations, two in the area of radioactive substance transport and 39 in small-scale nuclear activities (14 in the medical sector, 22 in the industrial, research or veterinary sectors, and three in the area of natural radioactivity – radon). Two significant events in 2023 were rated level 1 on the International Nuclear and Radiological Events Scale (INES scale), one in the industrial sector and one at the Ionisos facility in Pouzauges, and one event in radiotherapy was rated level 1+ on the ASN-SFRO scale. ASN Report on the state of nuclear safety and radiation protection in France in 2023 87

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