ISO 14971

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ISO 14971:2007

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ISO 14971:2007

Medical devices — Application of risk management to medical devices

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USD 239.00

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.

Standard Number ISO 14971:2007
Title ISO 14971:2007 Medical devices — Application of risk management to medical devices
Status Published
Publication Date 28 Feb 2007
Committee ISO/TC 210 Quality management and corresponding general aspects for medical devices
Publisher PECB Store
Format PDF
Pages 82
Price USD 239.00
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