可靠性标准YY/T1837—2022在有源植入式医疗器械研制中的应用探讨

Exploration of Application of Reliability Standard YY/T 1837-2022 in Development of Active Implantable Medical Devices

在医疗器械领域,长期缺乏高风险有源植入式医疗器械研制中可应用的可靠性通用技术要求框架,该研究结合YY/T 1837—2022的要求,全面阐释探讨了有源植入式医疗器械产品在研制各阶段可进行的可靠性工作的要求,为行业内产品可靠性工作提供参考。

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.