In the field of medical devices,there has been a long-term lack of a general technical requirements framework for reliability that can be applied in the development of high-risk active implantable medical devices.This study combines the requirements of YY/T 1837-2022 to comprehensively explain and explore the requirements for reliability work that can be performed at each stage of development of active implantable medical device products,and provides a reference for product reliability work in the industry.
关键词
有源植入式医疗器械/可靠性/标准应用
Key words
active implantable medical device/reliability/standard application
万方数据