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Norm

ÖNORM EN ISO 14971

Issue date: 2007 06 01

Medical devices - Application of risk management to medical devices (ISO 14971:2007)

This International Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical d...
Withdrawn: 2010 01 01
Publisher:
Austrian Standards International
Format:
Digital | 98 Pages
Language:
German | English
Optionally co-design standards:
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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ÖNORM EN 1441
1998 03 01
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Norm
ÖNORM EN ISO 14971
Issue date : 2009 12 15
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
Norm
ISO 14971:2007
Issue date : 2007 02 28
Medical devices — Application of risk management to medical devices (Corrected version 2007-09)