SIS-EN-ISO-14971 › Historical Revision Information
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
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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.
To find similar documents by classification:
11.040.01 (Medical equipment in general)
Medical devices
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Designation Name
SS-EN ISO 14971:2007
Revision Level
2007 EDITION
Status
Superseded
Publication Date
April 2, 2007
Language(s)
English
Page Count
88
International Equivalent
EN ISO 14971:2007(IDT); ISO 14971:2007(IDT)