Iso 14971 Medical devices – Application of risk management to medical devices
General information Iso 14971 pdf
Number of Pages: 82
Edition: 2 (Monolingual)
Stage: 90.93 (2010-11-02)
TC/SC: TC 210
ISO 14971 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.
Revises: ISO 14971:2000
Revises: ISO 14971:2000/Amd 1:2003