Historical
ONORM EN ISO 14971:2009
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) (Austrian Standard)
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.
CONTENT PROVIDER
Austrian Standards Institute [on]
Austrian Standards Institute [on]