1. INTRODUCTION
Background
1.1. Radionuclides are used worldwide in a range of medical, industrial, research and academic applications that bring many benefits to humankind. Most of these radionuclides are produced in reactors and particle accelerators. Facilities that produce radionuclides and facilities in which radionuclides are processed are referred to collectively as โradioisotope production facilitiesโ1. The operation of reactors and particle accelerators and the subsequent processing of radioactive material can present significant radiation hazards to workers, the public and the environment unless these facilities are properly controlled.
1.2. In 2017, there were 238 research reactors in operation, of which approximately 83 were deemed useful for regular radioisotope production [1]. In 2015, it was estimated that there were approximately 1200 cyclotrons worldwide used to some extent for radioisotope production [2]. The number of institutions that operate cyclotrons and manufacture and distribute radiopharmaceuticals that are used in positron emission tomography and single photon emission computed tomography is significant and growing.
1.3. IAEA Safety Standards Series No. GSR Part 3, Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards [3] establishes the basic requirements for protection of people and the environment against exposure to ionizing radiation and for the safety of radiation sources2. The application of these requirements at radioisotope production facilities is intended to prevent accidents and, generally, to provide for the best possible protection and safety measures under the prevailing circumstances. The magnitudes and likelihood of exposures and the number of individuals exposed are required to be kept as low as reasonably achievable, economic and societal factors being taken into account.
1.4. Unless otherwise stated, terms are used with the meanings ascribed to them in the IAEA Safety Glossary [4] and the definitions provided in GSR Part 3 [3].
Objective
1.5. The objective of this Safety Guide is to provide recommendations on how to meet the requirements of GSR Part 3 [3] with regard to radioisotope production facilities. This Safety Guide provides specific, practical recommendations on the safe design and operation of radioisotope production facilities for use by operating organizations, the designers of these facilities, and regulatory bodies.
Scope
1.6. This Safety Guide addresses the radiation safety and protection aspects of the process in which radioisotopes are produced in accelerators (principally cyclotrons), and of the process in which radioisotopes that have been produced in accelerators, or have been purified from other sources, are processed into radioactive products for subsequent use in, for example, nuclear medicine. It also addresses elements of the design and operation of accelerators (principally cyclotrons) that pertain directly to the production of radioisotopes.
1.7. The following types of facility that produce radioisotopes are within the scope of this Safety Guide:
(a) Facilities that process targets that have been irradiated by the charged particle beam of an accelerator to produce radioisotopes.
(b) Accelerator facilities with energies of less than 70 MeV/nucleon that are operated principally to produce radioisotopes. This Safety Guide addresses the following four types of accelerator:
(i) Low energy (<20 MeV/nucleon) cyclotrons used for medical radioisotope production;
(ii) 20โ40 MeV/nucleon cyclotrons used for radioisotope production;
(iii) >40 MeV/nucleon cyclotrons used for both research and radioisotope production;
(iv) Linear accelerators used for radioisotope production.
1.8. The use of radioactive material after its manufacture, and the standards and quality assurance procedures that pertain to its production, are outside the scope of this Safety Guide. The production of fissile material is outside the scope of this Safety Guide.
1.9. The design and operation of reactors is outside the scope of this Safety Guide; safety requirements for research reactors are established in IAEA Safety Standards Series No. SSR-3, Safety of Research Reactors [5].
1.10. Centralized radiopharmacies that manufacture radiopharmaceuticals from bulk quantities of radioisotopes are outside the scope of this Safety Guide.
1.1...