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About This Item
Full Description
This American National Standard specifies a procedure by which a manufacturer can identify the
hazards associated with medical devices and their accessories (including in vitro diagnostic
medical devices), estimate and evaluate the risks, control these risks, and monitor the
effectiveness of the control.
Includes Amendment 1, Rationale for Requirements, June 2003.
Includes Amendment 1, Rationale for Requirements, June 2003.
Document History
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AAMI/ISO 14971:2019
Medical devices - Application of risk management to medical devices- Most Recent
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AAMI/ISO 14971:2007/(R)2016
Medical Devices - Application of Risk Management to Medical Devices- Historical Version
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AAMI/ISO 14971:2000/A1:2003
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Medical Devices - Application of Risk Management to Medical Devices- Historical Version
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AAMI 14971
Risk management- Part 1: Application of risk management- Historical Version