ISO-14971 Medical devices - Application of risk management to medical devices

ISO-14971 - 3RD EDITION - CURRENT
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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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11.040.01 (Medical equipment in general)

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Document Number

ISO 14971:2019

Revision Level

3RD EDITION

Status

Current

Publication Date

Dec. 1, 2019

Committee Number

ISO/TC 210