Historical
SS-EN ISO 14971:2009
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) (Swedish Standard)
Standarden specificerar en process för tillverkare att identifiera de risker som är förknippade med medicintekniska produkter och hjälper dig att utveckla ett ledningssystem för riskhantering.Standarden kräver att tillverkaren ska uppskatta, beräkna och bedöma riskerna hos sina produkter, kontrollera dessa risker, samt att övervaka riskhanteringens effektivitet. Kraven i standarden är tillämpliga på alla stadier i livscykeln för en medicinteknisk produkt.
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.
Content Provider
Swedish Standards Institute [sis]
