This International Standard specifies a process for a manufacturer to identify the hazards associated withmedical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associatedrisks, to control these risks, and to monitor the effectiveness of the controls.
EN ISO 14971:2012 history
2021EN ISO 14971:2019/A11:2021 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
1970EN ISO 14971:2019 Medical devices - Application of risk management to medical devices
2012EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
2009EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
2007EN ISO 14971:2007 Medical devices - Application of risk management to medical devices
2000EN ISO 14971:2000 Medical Devices - Application of Risk Management to Medical Devices (Incorporates Amendment A1: 2003)