Oct 03, 2017 Risikomanagement DIN EN ISO 1. Aktuelle Informationen im Download zur Risikoanalyse nach ISO 14971 Risikomanagement. EN ISO provides a process for managing risks associated with medical devices. Because this standard describes an ongoing, lifecycle process. ISO 14971 defines risk analysis as “a systematic use of available information to identify hazards and to estimate the risk” (2007, p. As per the definition, the standard provides a.
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); German version EN ISO 14971:2012 (Foreign Standard)
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. This International Standard does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management system.
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