This International 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. 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 decision making. This International Standard does not specify acceptable risk levels.

CEI UNI EN ISO 14971 (2013), Application of risk management to medical devices. Rasmussen, J. Information processing and humanmachine interaction. Hindi Typing Book Free Download Pdf. An approach to cognitive engineering. Understanding adverse events: human factors. Family Fortunes Powerpoint Template Download. Quality in health care, 4(2), 80-89. ISO/IEC 17024: Conformity assessment - General requirements for bodies operating certification of persons is an International Standard which specifies criteria for.