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| Research on standard system for medical devices of additive manufacturing for medical applications |
| MAO Xin HAN Qianqian▲#br# |
| National Institutes for Food and Drug Control, Beijing 102629, China |
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Abstract The medical device based on additive manufacturing is a complex system which integrates multi-disciplinary mechanism and various technologies, thus the quality should be strictly controlled. Development of special technical standard system is needed to guide the industry, so as to promote product quality. This paper describes the current situation of the standardization. Internationally, ISO/TC 261 and ASTM F42 are mainly engaged in related standardization and research, and SAC/TC 562 is responsible for domestic standards in China. In the medical field, standardization development organization for medical additive manufacturing is responsible for standardization. According to the quality control focus of additive manufacturing technology and medical devices, this paper proposes the design and research ideas of standard system from five aspects of basic standards, data/software, equipment, materials and process/method, providing reference for the scientific and orderly development of medical device standardization in medical additive manufacturing technology in China.
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