ISO 14971:2007 

Medical devices - Application of risk management to medical devices

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Abstract

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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Additional information

Publication typeInternational Standard
Publication date2007-03-31
Edition2.0
Available language(s)English, French, Russian
TC/SCTC 62/SC 62A - Common aspects of electrical equipment used in medical practicerss
ICS11.040.01 - Medical equipment in general
Stability date  2019
Pages98
File size1660 KB

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