SR EN ISO 14971:2012

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

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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General information

Status : Withdrawn
Approval date : 12/21/2012
Withdrawal date : 3/31/2020
Number of pages : 104
ICS : 11.040.01 Medical equipmet in general
Technical Committee : 377 - Medical devices

Relations with other standards:

Replaces SR EN ISO 14971:2009
Replaced by SR EN ISO 14971:2020