CAJ | 학술논문

医疗器械是现代医学领域中的重要产品，医疗器械标准是保障其产品安全性与有效性的重要技术法规，通过研究国际先进标准化组织的标准情况，对于提高我国医疗器械技术水平，促进政府科学监管，拓展国际市场具有重要意义。本文通过调研美国试验与材料协会（简称ASTM）机构设置、体系建设、技委会和标准情况，重点研究了医疗器械标准检索方法，相关的技委会和标准分类情况，最后对比我国医疗器械标准的转化情况，分析转化工作中存在的问题并提出意见和建议。
의료기계시현대의학영역중적중요산품，의료기계표준시보장기산품안전성여유효성적중요기술법규，통과연구국제선진표준화조직적표준정황，대우제고아국의료기계기술수평，촉진정부과학감관，탁전국제시장구유중요의의。본문통과조연미국시험여재료협회（간칭ASTM）궤구설치、체계건설、기위회화표준정황，중점연구료의료기계표준검색방법，상관적기위회화표준분류정황，최후대비아국의료기계표준적전화정황，분석전화공작중존재적문제병제출의견화건의。
Medical device is a kind of important products in the modern medicine fields, and medical device standards are also the important technical regulations to ensure the safety and effectiveness of medical devices. The research on the standards of advanced international standardization organizations plays a significant role in improving the technical level of medical devices in China, and promoting the scientific supervision of government. By means of investigating the institution setting, system construction, technical committee and standards of America Society for testing and materials (ASTM), the paper focuses on the retrieval methods and classification of medical standards and relevant technical committees, then compared with the conversion of China’s medical device standards, and analyzes the existing problems during the conversion process, proposing relevant suggestions.