放射性同位素制品技术标准建设的现状与思考

随着国家对民用核技术应用领域的大力支持,我国放射性同位素制品行业迎来了前所未有的机遇与发展.然而,行业快速扩张也带来了市场规模与行业技术标准体系发展不匹配的问题.目前有关国内放射性同位素制品行业技术标准体系建设的研究甚少,本文从行业市场规模及标准体系现状出发,分别探讨放射性药物和放射源行业在标准体系建设方面的现状及存在...

Present Situation and Consideration of the Construction of Technical Standards for Radioisotope Products

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 In the field of radioactive sources, there are problems with outdated standards, low participation in the formulation of international standards and small coverage of standards exist.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.