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106 pages. BS EN ISO 14971 is a key standard specifying 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 standard are applicable to all stages of the life-cycle of a medical device.
It does not apply to clinical decision making, does not specify acceptable risk levels and 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.
Descriptors: Risk analysis, Management, Hazards, Risk assessment, Safety measures, Diagnosis (medical), Medical instruments, Clinical investigation instruments, Medical equipment
Replaces: BS EN ISO 14971:2009
British Standards Institute
Publication Date:1 January 2012
ISBN: 978058079952 5
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