风险管理原则在医疗器械标准制修订过程中的应用

Application of Risk Management Principle During Standard Establishment of Medical Devices

本文介绍了风险管理原则在医疗器械产品标准制定过程中的应用,将风险管理原则融入标准涉及安全内容的制修订过程之中。

To integrate risk management principle into security requirements of standard establishment process, we focus on introducing application of risk management principle during product standard establishment of medical devices.