SSH EN ISO 14971:2009

Pajisje mjekësore - Zbatimi i drejtimit të rrezikut në pajisjet mjekësore (ISO 14971:2007, Versioni i korrigjuar 2007-10-01)

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

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.

Related directives

Directives related to this standards.