风险管理

本类别共 2 条标准。

标准编号	标题	适用范围	GSPR
ISO 14971:2019	Medical devices — Application of risk management to medical devices	Risk management throughout device lifecycle	1, 2, 3, 4
ISO/TR 24971:2020	Medical devices - Guidance on the application of ISO 14971	Medical devices -- Guidance on the application of ISO 14971 for risk management ...	2, 3, 3(e), 3(a)