CSA Group Medical Devices - Application of Risk Management to Medical Devices (Adopted ISO 14971:2007, second edition, 2007-03-01)

Preface This is the second edition of CAN/CSA-ISO 14971, Medical devices - Application of risk management to medical devices, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 14971 (second edition, 2007-03-01). This Standard supersedes the previous edition published in 2001 as CAN/CSA-ISO 14971 (adopted ISO 14971:2000) and CSA Amendment 1:2003 to CAN/CSA-ISO 14971:01 (adopted ISO Amendment 1:2003).  Scope 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.