Comments on amendments and additions to the mandatory requirements for radiation safety in radionuclide diagnostics and therapy

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radiation safety during radionuclide diagnostics and therapy procedures before September 1, 2025 are significantly outdated and do not reflect the technologies and radionuclides currently in use.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.