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 medicaldevices. It is used as reading materials for personnel of testing institutions and evaluation institutions in medical devices.