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ISO 14971 (2007-03)

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ISO 14971 (2007-03)

ISO 14971:2007 Medical devices - Application of risk management to medical devices

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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.

Author ISO
Editor ISO
Document type Standard
Format File
Edition 2.0
ICS 11.040.01 : Medical equipment in general
Number of pages 82
Year 2007
Country Switzerland
Keyword IEC14971;ISO 14971:2007