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

ISO-14971 - 2ND EDITION REPRINT - 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 14971:2007

Revision Level

2ND EDITION REPRINT

Status

Current

Publication Date

Oct. 1, 2007

Committee Number

ISO/TC 210