ISO 14971, Medical devices — Application of risk management to medical devices, provides guidance for the application of risk management processes for the manufacturers of medical devices. The standard helps manufacturers identify the hazards associated with the devices, estimate and evaluate the associated risks, control these risks, and monitor the effectiveness of the controls.
ISO 14971 originates from norms EN 1441 published in 1997 and ISO 14971-1 published in 1998. The first edition of ISO 14971 was published in 2000. The second edition, which is currently referenced by most of the standards, was published in 2007. The newest edition of ISO 14971 was published in 2019.
Implementation of risk management processes according to ISO 14971 is required by multiple standards, for example IEC 60601-1 (for medical electrical equipment), IEC 61010-2-040 (for sterilizers) and IEC 61010-2-101 (for in vitro diagnostic medical equipment).
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