Comments on amendments and additions to the mandatory requirements for radiation safety in X-ray diagnostics and therapy
https://doi.org/10.21514/1998-426X-2025-18-3-85-94
Abstract
Starting from September 1, 2025, SanPiN 2.6.4115-25 came into force. This is a comprehensive document that establishes requirements for ensuring radiation safety when working with a specific list of ionizing radiation sources, including those used in X-ray diagnostics and therapy. As a result, several regulatory legal acts in the field of radiation safety will be repealed, including SanPiN 2.6.1.1192-03 and SanPiN 2.6.1.2891-11. SanPiN 2.6.4115-25 introduces a number of new as well as revised and updated requirements for ensuring radiation safety in the operation of ionizing radiation-generating equipment used in medical practice. This paper presents analysis of the changes and additions introduced in SanPiN 2.6.4115-25 in comparison with the documents that should be repealed starting from September 1, 2025, which previously regulated radiation safety requirements for X-ray diagnostics and therapy. Conclusion: The work presents the background for revising the sanitary rules and standards and provides recommendations for improving the regulation of radiation protection in medical exposure.
About the Authors
A. V. VodovatovRussian Federation
Aleksandr V. Vodovatov – Candidate of Biological Sciences, Head of Laboratory of Radiation Hygiene of Medical Facilities; Docent
8, Mira Str., Saint Petersburg,, 197101
G. A. Gorsky
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
L. A. Chipiga
Russian Federation
Larisa A. Chipiga – Candidate of Engineering Sciences, Research Fellow, Laboratory of Radiation Hygiene of Medical Facilities; Research Fellow; Docent
Saint Petersburg
A. V. Likhacheva
Russian Federation
Anastasia V. Likhacheva – Junior Research Fellow, Laboratory of Radiation Hygiene of Medical Facilities; Radiation Safety Engineer
Saint Petersburg
I. G. Shatsky
Russian Federation
Ilya G. Shatsky – Research Fellow, Laboratory of Radiation Hygiene of Medical Facilities
Saint Petersburg
P. S. Druzhinina
Russian Federation
Polina S. Druzhinina – Junior Research Fellow, Laboratory of Radiation Hygiene of Medical Facilities
Saint Petersburg
N. M. Vishnyakova
Russian Federation
Nadezhda M. Vishnyakova – Doctor of Medical Sciences, Deputy Director
Saint Petersburg
References
1. IAEA Safety Standards Series. No. GSR Part 3. Radiation Protection and Safety of Radiation Sources. STI/PUB/1578. IAEA: Vienna; 2014. 518 p.
2. Golikov VYu, Vodovatov AV. Еstimation of an X-ray machine’s workload during routine radiological examinations. Radiatsionnaya Gygiena = Radiation Hygiene. 2015;8(2): 6-10. (In Russian).
3. Golikov VYu. About the necessary thickness of stationary shield in X-ray dental rooms. Radiatsionnaya Gygiena = Radiation Hygiene. 2024;17(2): 46-52. (In Russian). DOI: 10.21514/1998-426X-2024-17-2-46-52
4. Golikov VYu, Vodovatov AV. Critical analysis and suggestions to improve the existing system of radiation control in X-ray rooms. Radiatsionnaya Gygiena = Radiation Hygiene. 2021;14(2): 39-47. (In Russian). DOI: 10.21514/1998-426X-2021-14-2-39-47
5. 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
6. Druzhinina PS, Chipiga LA, Golikov VYu, Vodovatov AV, Bazhin SYu, Shleenkova EN, et al. Improving the approach to calculating shielding in computed tomography rooms. Radiatsionnaya Gygiena = Radiation Hygiene. 2024;17(2): 64-75. (In Russian). DOI: 10.21514/1998-426X-2024-17-2-64-75
7. Vodovatov AV. Practical implementation of the diagnostic reference levels concept for the common radiographic examinations. Radiatsionnaya Gygiena = Radiation Hygiene. 2017;10(1): 47-55. (In Russian). DOI: 10.21514/1998-426X-2017-10-1-47-55
8. Romanovich IK, Vodovatov AV, Biblin AM, Kormanovskaya TA. On the issue of the development of legislative and regulatory provision of the radiation safety of the public. Radiatsionnaya Gygiena = Radiation Hygiene. 2022;15(1): 88-95. (In Russian). DOI: 10.21514/1998-426X-2022-15-1-88-95
9. Vodovatov AV, Chipiga LA, Ryzhov SA, Petryakova AV, Biblin AM, Gorsky GA. Radiation accidents in X-ray and radionuclide diagnostics and therapy: comparison of Russian and international approaches to the terminology and classification. Radiatsionnaya Gygiena = Radiation Hygiene. 2024;17(1): 97-110. (In Russian). DOI: 10.21514/1998-426X-2024-17-1-97-110
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, Vodovatov AV, Petryakova AV, Zvonova IA, 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
12. 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
13. 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
14. Vodovatov AV, Chipiga LA, Ryzhov SA, Likhacheva AV, Biblin AM, Gorsky GA, et al. Suggestions for amendments to responding approaches to events in medical exposure of patients within the updating sanitary and epidemiological legislation. Radiatsionnaya Gygiena = Radiation Hygiene. 2024;17(4): 96-107. (In Russian). DOI: 10.21514/1998-426X-2024-17-4-96-107
15. Vodovatov AV, Romanovich IK, Alekhnovich AV, Biblin AM. Radiation Safety of Patients in Diagnostic Radiology in the Russian Federation: Current Status, Problems and Solutions. Meditsinskaya Fizika = Medical Physics. 2024;4: 33-49. (In Russian). DOI 10.52775/1810-200X-2024-104-4-33-49
16. Vodovatov AV, Golchenko OA, Mashchenko IA, Alekseeva DV. Evaluation of fetal absorbed doses from computed tomography examinations of pregnant patients: A systematic review. Digital Diagnostics. 2023:2(4): 170-184. (In Russian). DOI 10.17816/DD472150
17. Baltrukova TB, Voronkova SV, Vodovatov AV. Topical issues of the provision of the radiation safety for dental X-ray examinations. Radiatsionnaya Gygiena = Radiation Hygiene. 2022;15(1): 111-119. (In Russian). DOI: 10.21514/1998-426X-2022-15-1-111-119
18. 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.
19. Chinese Medicine Hospital - Schedule of Accommodation. Available from: https://www.healthbureau.gov.hk/en/press_and_publications/otherinfo/200900_cmhp/index.html [Accessed 14.07.2025].
20. Health Building Note 6: Volume 1, Facilities for Diagnostic Imaging and Interventional Radiology. Available from: https://www.england.nhs.uk/publication/designing-facilities-for-diagnostic-imaging-hbn-6/ [Accessed 14.07.2025].
21. Australasian Health Facility Guidelines. Part B: Health Facility Briefing and Planning. Revision: 6.0 Available from: https://healthfacilityguidelines.com.au/part/part-b-health-facility-briefing-and-planning-0 [Accessed 14.07.2025].
22. 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].
Review
For citations:
Vodovatov A.V., Gorsky G.A., Chipiga L.A., 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 X-ray diagnostics and therapy. Radiatsionnaya Gygiena = Radiation Hygiene. 2025;18(3):85-94. (In Russ.) https://doi.org/10.21514/1998-426X-2025-18-3-85-94