ISO/TR 24971-2013
医疗器械.ISO 14971标准的应用导则
Medical devices - Guidance on the application of ISO 14971
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- 适用范围
- This Technical Report provides guidance in addressing specific areas of ISO 14971 when implementing risk management. The guidance is intended to assist manufacturers and other users of the standard to: —understand the role of international product safety and process standards in risk management; —develop the policy for determining the criteria for risk acceptability; —incorporate production and post-production feedback loop into risk management; — differentiate between "information for safety" and "disclosure of residual risk"; and —evaluate overall residual risk.