Journal of Isotopes (Apr 2022)
Present Situation and Consideration of the Construction of Technical Standards for Radioisotope Products
Abstract
In recent years, with the current strong support for the application of civil nuclear technology, Chinese radioisotope products industry has ushered in unprecedented opportunities and development. However, the rapid expansion of the industry also brings the problem of market size and the development of the industry technical standard system mismatch. In view of the lack of research on technical standard system construction of radioactive isotope products industry in China, this paper discusses the current situation and existing problems in standard system construction of radioactive drugs and radioactive sources industry respectively from the market scale and standard system status. At present, the existing standard system framework can basically meet the quality control of listed products, but in the field of radiopharmaceutical, there is a lack of analytical testing technology, nuclide and quality control key equipment verification standards. In the field of radioactive sources, there are problems with outdated standards, low participation in the formulation of international standards and small coverage of standards exist. Aiming at these problems, upgrading and improving the radioactive isotope products standard system systematically, complementing the existing standard system of blank area and weak area, completing the standard cohesion at various levels shall strengthen the standard stable cross, promoting widespread promotion and application of standards in the industry and enhancing the level of standard internationalization and so on were put forward, which hope to provide a reference for the construction of the technical standard system for radioisotope products.
