ISO 14971:2007 Preview
Medical devices -- Application of risk management to medical devices
This standard was last reviewed and confirmed in 2010. Therefore this version remains current.
ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.