This International 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.The requirements of this International Standard are applicable to all stages of the life cycle of a medical device.This International Standard does not apply to clinical judgements relating to the use of a medical device.It does not specify acceptable risk levels.This International Standard does not require that the manufacturer has a formal quality system in place. However@ risk management can be an integral part of a quality system (see@ for example@ Table G.1).
EN ISO 14971:2007 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)