ISO 14971:2007
International Standard
Historical
·
Approved on
28 February 2007
Medical devices — Application of risk management to medical devices
ISO 14971:2007 Files
English
82 Pages
Historical
103.06 OMR
ISO 14971:2007 Scope
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.
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