This book focuses on the reliability engineering of medical devices, especially digital diagnosis and treatment equipment in China. It details the professional technologies and application methods of reliability design analysis, fault model analysis and reliability test of digital diagnosis and treatment equipment, to meet the needs of project undertakers of digital diagnosis and treatment equipment.

From the three aspects: safety analysis and EMC design protection, material selection and control, and software engineering and quality, this book provides professional and technical ideas and methods of reliability for the quality problems prone to occur in the field of medical devices, as well as method guidance for readers. Meanwhile, it runs through the whole process of design, engineering, testing, production and management of all digital diagnosis and treatment equipment research and development enterprises and even product R & D enterprises in the field of medical devices. It is used as reading materials for personnel of testing institutions and evaluation institutions in medical devices.

Auteur

Xiuqing Li engages in biomedical engineering and the accelerator industry. He graduated from Tsinghua University and is now the assistant director and researcher of the Department of Engineering Physics of Tsinghua University. He has completed a number of "ten thousand people plan" of China's medical device scientific research and industrialization projects and has participated in planning China's medical device field many times. He is the main author of the guide for the research and development of digital diagnosis and treatment equipment, a pilot project of China's 13th five year plan.

Jun Gao graduated from the school of mechanical and electrical engineering of Harbin University of technology in 2003 and obtained the title of senior engineer in China in 2010. He is the editor in chief of the first and second key projects of China's rapid medical equipment research and development and reliability evaluation

Wen Li graduated from the Department of electrical engineering of Harbin University of technology in 1987. He is a senior engineer. He has worked in Beijing medical device inspection institute for more than 20 years and has been engaged in professional and technical work such as medical device product testing, standard formulation and laboratory management system for a long time. He is presided over and completed the testing of the national key R & D project "proton and heavy ion therapy equipment" innovation project of the Ministry of Science and Technology of China.