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About This Item
Full Description
Valuable checklist also available to assist with compliance to this standard.
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.
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.
Document History
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AAMI/ISO 14971:2019
currently
viewing
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
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