Comments on amendments and additions to the mandatory requirements for radiation safety in radionuclide diagnostics and therapy
L. A. Chipiga,
G. A. Gorsky,
A. V. Vodovatov,
A. V. Likhacheva,
I. G. Shatsky,
P. S. Druzhinina,
N. M. Vishnyakova https://doi.org/10.21514/1998-426X-2025-18-3-95-104
Abstract
The regulatory legal acts of Rospotrebnadzor that established requirements for ensuring radiation safety during radionuclide diagnostics and therapy procedures before September 1, 2025 are significantly outdated and do not reflect the technologies and radionuclides currently in use. The development of nuclear medicine technologies and the introduction of an increasingly wide range of therapeutic radiopharmaceutical drugs necessitate the updating of requirements for the conduct of procedures, patient discharge, and waste management during radionuclide therapy, as well as the consideration of modern practices in organizing radionuclide therapy units based on radionuclide diagnostics departments. This work presents an analysis of the changes and additions introduced in SanPiN 2.6.4115-25, aimed at establishing unified requirements for ensuring radiation safety for personnel, the public, and patients during nuclear medicine procedures. The requirements implemented in SanPiN 2.6.4115-25 for ensuring radiation safety during nuclear medicine procedures have addressed two important scientific and practical problems: accounting for the specifics of modern nuclear medicine methods and resolving a number of contradictions among the existing regulatory legal acts of Rospotrebnadzor. Conclusion: SanPiN 2.6.4115-25 is fully harmonized with international regulatory documents and comprehensively includes requirements for ensuring radiation safety in radionuclide therapy, with an emphasis on protecting the public from radiation exposure.
Keywords
radiation safety,
radiation hygiene,
sanitary norms and rules,
nuclear medicine,
radionuclide diagnostics,
radionuclide therapy
Supporting agencies: The work was performed as a part of the program of Federal Service for Surveillance on Consumer Rights Protection and Human Well-Being “Development and scientific justification of a set of measures to ensure radiation protection in nuclear medicine”.
About the Authors
L. A. Chipiga
Saint Petersburg Research Institute of Radiation Hygiene after Professor P.V. Ramzaev, Federal Service for Surveillance of Consumer Rights Protection and Human Wellbeing; A. Granov Russian Scientific Center of Radiology and Surgical Technologies of the Ministry of Health of the Russian Federation; Almazov National Medical Research Centre of the Ministry of Health of the Russian Federation, Saint Petersburg
Russian Federation
Russian Federation
Larisa A. Chipiga – Candidate of Engineering Sciences, Research Fellow, Laboratory of Radiation Hygiene of Medical Facilities; Research Fellow; Docent
8, Mira Str., Saint Petersburg, 197101
G. A. Gorsky
Saint Petersburg Research Institute of Radiation Hygiene after Professor P.V. Ramzaev, Federal Service for Surveillance of Consumer Rights Protection and Human Wellbeing; North-Western State Medical University named after I.I. Mechnikov
Russian Federation
Russian Federation
Grigory A. Gorsky – Candidate of Medical Sciences, Deputy Director of Innovation Work; Associate Professor, Department of Hygiene of Conditions of Education, Training, Work and Radiation Hygiene
Saint Petersburg
A. V. Vodovatov
Saint Petersburg Research Institute of Radiation Hygiene after Professor P.V. Ramzaev, Federal Service for Surveillance of Consumer Rights Protection and Human Wellbeing; Saint Petersburg State Pediatric Medical University
Russian Federation
Russian Federation
Aleksandr V. Vodovatov – Candidate of Biological Sciences, Head of Laboratory of Radiation Hygiene of Medical Facilities; Docent
Saint Petersburg
A. V. Likhacheva
Saint Petersburg Research Institute of Radiation Hygiene after Professor P.V. Ramzaev, Federal Service for Surveillance of Consumer Rights Protection and Human Wellbeing; The City Hospital No 40 of the Kurortny District
Russian Federation
Russian Federation
Anastasia V. Likhacheva – Junior Research Fellow, Laboratory of Radiation Hygiene of Medical Facilities; Radiation Safety Engineer
Saint Petersburg
I. G. Shatsky
Saint Petersburg Research Institute of Radiation Hygiene after Professor P.V. Ramzaev, Federal Service for Surveillance of Consumer Rights Protection and Human Wellbeing
Russian Federation
Russian Federation
Ilya G. Shatsky – Research Fellow, Laboratory of Radiation Hygiene of Medical Facilities
Saint Petersburg
P. S. Druzhinina
Saint Petersburg Research Institute of Radiation Hygiene after Professor P.V. Ramzaev, Federal Service for Surveillance of Consumer Rights Protection and Human Wellbeing
Russian Federation
Russian Federation
Polina S. Druzhinina – Junior Research Fellow, Laboratory of Radiation Hygiene of Medical Facilities
Saint Petersburg
N. M. Vishnyakova
Saint Petersburg Research Institute of Radiation Hygiene after Professor P.V. Ramzaev, Federal Service for Surveillance of Consumer Rights Protection and Human Wellbeing; North-Western State Medical University named after I.I. Mechnikov
Russian Federation
Russian Federation
Nadezhda M. Vishnyakova – Doctor of Medical Sciences, Deputy Director
Saint Petersburg
References
1. Vodovatov AV, Gorsky GA, Chipiga LA, Shatsky IG, Druzhinina PS, et al. Comments on amendments and additions to the mandatory requirements for radiation safety in X-ray diagnostics and therapy. Radiatsionnaya Gygiena = Radiation Hygiene. 2025;18(3):85-94. (In Russian). DOI: 10.21514/1998-426X-2025-18-3-85-94.
2. Chipiga LA, Kozlova KN, Zvonova IA, Vodovatov AV, Biblin AM, Stanzhevsky AA. The geography and structure of nuclear medicine centres in the Russian Federation in 2025. Radiatsionnaya Gygiena = Radiation Hygiene. 2025;18(2): 124–135. (In Russian). DOI: 10.21514/1998-426X-2025-18-2-124-135.
3. Guidelines “Quality assessment and quality control of the examinations in radionuclide diagnostics”. Moscow; St. Petersburg: RKHGA publishing house; 2023. 110 p. (In Russian).
4. The design of diagnostic medical facilities where ionizing radiation is used. A code of practice issued by the Radiological Protection Institute of Ireland. Ireland, Dublin; 2009. 108 p.
5. Chinese Medicine Hospital - Schedule of Accommodation. Онлайн-ресурс. Available from: https://www.healthbureau.gov.hk/en/press_and_publications/otherinfo/200900_cmhp/index.html [Accessed 14.07.2025].
6. Health Building Note 6: Volume 1, Facilities for Diagnostic Imaging and Interventional Radiology. Онлайн-ресурс. Available from: https://www.england.nhs.uk/publication/designing-facilities-for-diagnostic-imaging-hbn-6/ [Accessed 14.07.2025].
7. Australasian Health Facility Guidelines. Part B: Health Facility Briefing and Planning. Revision: 6.0 Онлайн-ресурс. Available from: https://healthfacilityguidelines.com.au/part/part-b-health-facility-briefing-and-planning-0 [Accessed 14.07.2025].
8. International Health Facility Guidelines. Health Facility Briefing and Design. Medical Imaging Unit – General. Available from: https://www.healthfacilityguidelines.com/GuidelineIndex/Index/Health-Facility-Briefing-and-Design [Accessed: 14.07.2025].
9. Chipiga LA, Vodovatov AV, Petryakova AV, Zvonova I.A., Stanzhevsky AA, Maistrenko DN, et al. Justification of differential approach to management of patient biological waste in nuclear medicine departments. Radiatsionnaya Gygiena = Radiation Hygiene. 2022;15(4): 34-44. (In Russian). DOI: 10.21514/1998-426X-2022-15-4-34-44.
10. Chipiga LA, Vodovatov AV, Zvonova IA, Stanzhevsky AA, Petryakova AV, Anokina EE, et al. Management of biological waste of patients after radionuclide therapy. Radiatsionnaya Gygiena = Radiation Hygiene. 2022;15(2): 19-30. (In Russian). DOI: 10.21514/1998-426X-2022-15-2-19-30.
11. Chipiga LA, Ryzhov SA, Vodovatov AV, Zvonova IA, Petryakova AV, Stanzhevsky AA, et al. Problems of management of patient biological waste in radionuclide diagnostics. Radiatsionnaya Gygiena = Radiation Hygiene. 2024;17(3): 29-38. (In Russian). DOI: 10.21514/1998-426X-2024-17-3-29-38.
12. Petryakova AV, Chipiga LA, Zvonova IA, Vodovatov AV, Gorsky GA, Stanzhevsky AA. Radiation safety problems during the patient traveling by public transport after radiopharmaceutical therapy with 131I. Radiatsionnaya Gygiena = Radiation Hygiene. 2024;17(2): 97-108. (In Russian). DOI: 10.21514/1998-426X-2023-17-2-97-108.
13. Chipiga LA, Petryakova AV, Vodovatov AV, Saprykin KS, Vazhenina DA, Stanzhevsky AA, et al. Estimation of 223Ra in a sewage system of hospital during radiopharmaceutical therapy with 223Ra dichloride (Xofigo®). Cancer Urology. 2024;20(3): 94-103. (In Russian). DOI: 10.17650/1726-9776-2024-20-3-94-103.
14. ICRP. Release of Patients after Therapy with Unsealed Radionuclides. ICRP Publication 94. Annals of the ICRP. 2004;34(2).
15. Radiation Protection and Safety in Medical Uses of Ionizing Radiation, IAEA Safety Standards Series No. SSG-46, IAEA, Vienna; 2018.
16. International Atomic Energy Agency. Safety report series No. 63. Release of Patients after radionuclide therapy with contribution from the ICRP. Vienna; 2009.
17. RadiCatch Toilet Filtration System for Nuclear Medicine. Available from: https://www.southernscientific.co.uk/products-by-manufacturer/zereau/radicatch?utm_source=chatgpt.com [Accessed: 14.07.2025].
18. Wall-hung separation toilets. Toilet for separation and disposal of radioactive waste. Available from: https://www.lemerpax.com/en/products/suspended-separation-toilets/ [Accessed 14.07.2025].
19. Chipiga LA, Zvonova IA, Vodovatov AV, Petryakova AV, Stanzhevsky AA, Vazhenina DA, et al. Improvement of the approach to definition of patient release criteria after radionuclide therapy. Radiatsionnaya Gygiena = Radiation Hygiene. 2023;16(2): 19-31. (In Russian). DOI: 10.21514/1998-426X-2023-16-2-19-31.
20. Schuchardt C, Zhang J, Kulkarni HR, Chen X, Müller D, Baum RP. Prostate-Specific Membrane Antigen Radioligand Therapy Using 177Lu-PSMA I&T and 177Lu-PSMA-617 in Patients with Metastatic Castration-Resistant Prostate Cancer: Comparison of Safety, Biodistribution, and Dosimetry. Journal of Nuclear Medicine. 2022;63: 1199–1207. DOI: 10.2967/jnumed.121.262713.
21. Turner JH. Outpatient therapeutic nuclear oncology. Annals of Nuclear Medicine. 2012;26: 289–297.
22. Chipiga L, Likhacheva A, Vodovatov A, Zvonova I, Stanzhevskiy A, Vazhenina D, et al. Harmonization of practice of release of patients after radiopharmaceutical therapy. Journal of Radiological Protection. 2025;45(1). DOI: 10.1088/1361-6498/adba70.
23. Chipiga LA, Likhacheva AV, Zvonova IA, Vodovatov AV, Toskin OYu, Sapelnikov AA, et al. Precautions for certain categories of individuals in contact with a patient after radionuclide therapy. Radiatsionnaya Gygiena = Radiation Hygiene. 2025;18(1): 59-69. (In Russian). DOI: 10.21514/1998-426X-2025-18-1-59-69.
24. Golikov VYu, Chipiga LA, Vodovatov AV, Smolyarchuk MYa. Some aspects of radiation protection in radionuclide therapy departments. Radiatsionnaya Gygiena = Radiation Hygiene. 2021;14(1): 75-85. (In Russian). DOI: 10.21514/1998-426X-2021-14-1-75-85.
25. Shleenkova EN, Bazhin SYu, Bogatyreva VYu. Results of individual dosimetric monitoring of the hands skin for personnel engaged in working with radiopharmaceuticals. Radiatsionnaya Gygiena = Radiation Hygiene. 2024;17(4): 35-42. (In Russian). DOI: 10.21514/1998-426X-2024-17-4-35-42.
26. ORAMED: Optimization of Radiation Protection of Medical Staff: EURADOS Report 2012-02, Braunschweig; April 2012. DOI: 10.12768/yc01-0d55.
27. Petryakova AV, Chipiga LA, Vodovatov AV, Smolyarchuk MYa. Equipment quality control during patient radiation protection optimisation in radionuclide diagnostics. Radiatsionnaya Gygiena = Radiation Hygiene. 2023;16(3): 81-90. (In Russian). DOI: 10.21514/1998-426X-2023-16-3-81-90.
28. Chipiga LA, Ladanova ER, Vodovatov AV, Zvonova IA, Mosunov AA, Naurzbaeva LT, et al. Trends in the development of nuclear medicine in the Russian Federation for 2015–2020. Radiatsionnaya Gygiena = Radiation Hygiene. 2022;15(4): 122-133. (In Russian). DOI: 10.21514/1998-426X-2022-15-4-122-133.
29. Druzhinina PS, Chipiga LA, Ryzhov SA, Vodovatov AV, Berkovich GV. Smirnov AV, et al. Proposals for the Russian quality assurance program in computed tomography. Radiatsionnaya Gygiena = Radiation Hygiene. 2021;14(1): 17-33. (In Russian). DOI: 10.21514/1998-426X-2021-14-1-17-33.
Review
For citations:
Chipiga L.A., Gorsky G.A., Vodovatov A.V., Likhacheva A.V., Shatsky I.G., Druzhinina P.S., Vishnyakova N.M. Comments on amendments and additions to the mandatory requirements for radiation safety in radionuclide diagnostics and therapy. Radiatsionnaya Gygiena = Radiation Hygiene. 2025;18(3):95-104. (In Russ.) https://doi.org/10.21514/1998-426X-2025-18-3-95-104
Views:
14
Email this article 