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CSA - CAN/CSA-ISO-14971-1-99

Medical Devices - Risk Management - Part 1: Application of Risk Analysis

inactive
Organization: CSA
Publication Date: 1 March 1999
Status: inactive
Page Count: 28
scope:

This part of ISO 14971 specifies a procedure for investigating, using available information, the safety of a medical device, including in vitro diagnostic devices (IVD) or accessories, by identifying hazards and estimating the risks associated with the device. It may be of particular assistance in areas where relevant standards are not available or not used.

This part of ISO 14971 does not stipulate levels of acceptability because these are determined by a multiplicrty of factors that cannot be set down in such a standard.

This part of ISO 14971 is not intended to give guidance on all aspects of management of risks. Furthermore, it is not intended to cover decision-making processes regarding assessment of the indications and contra-indications for the use of a particular device.

Document History

ISO 14971:21
January 1, 2021
Medical devices - Application of risk management to medical devices
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process...
CAN/CSA-ISO 14971-07
May 1, 2007
Medical Devices - Application of Risk Management to Medical Devices
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...
CAN/CSA-ISO 14971-07
May 1, 2007
Medical Devices - Application of Risk Management to Medical Devices
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...
CSA ISO 14971
January 1, 2007
Medical devices - Application of risk management to medical devices
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...
CAN/CSA-ISO 14971-01
September 1, 2001
Medical Devices - Application of Risk Management to Medical Devices
This International Standard specifies a procedure by which a manufacturer can identify the hazards associated with medical devices and their accessories, including in vitro diagnostic medical...
CAN/CSA-ISO 14971-01
September 1, 2001
Medical Devices - Application of Risk Management to Medical Devices
This International Standard specifies a procedure by which a manufacturer can identify the hazards associated with medical devices and their accessories, including in vitro diagnostic medical...
CAN/CSA-ISO 14971-01
September 1, 2001
Medical Devices - Application of Risk Management to Medical Devices
This International Standard specifies a procedure by which a manufacturer can identify the hazards associated with medical devices and their accessories, including in vitro diagnostic medical...
CAN/CSA-ISO 14971-01
September 1, 2001
Medical Devices - Application of Risk Management to Medical Devices
This International Standard specifies a procedure by which a manufacturer can identify the hazards associated with medical devices and their accessories, including in vitro diagnostic medical...
CAN/CSA-ISO-14971-1-99
March 1, 1999
Medical Devices - Risk Management - Part 1: Application of Risk Analysis
This part of ISO 14971 specifies a procedure for investigating, using available information, the safety of a medical device, including in vitro diagnostic devices (IVD) or accessories, by identifying...
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References

This document references:
IEC 60812 - Failure modes and effects analysis (FMEA and FMECA)
Published by IEC on August 1, 2018
This document explains how failure modes and effects analysis (FMEA), including the failure modes, effects and criticality analysis (FMECA) variant, is planned, performed, documented and maintained....
This document references:
IEC 61025 - Fault Tree Analysis (FTA)
Published by IEC on December 1, 2006
This International Standard describes fault tree analysis and provides guidance on its application as follows: – definition of basic principles; - describing and explaining the associated...
This document references:
IEC/TR 60513 - Fundamental Aspects of Safety Standards for Medical Electrical Equipment
Published by IEC on January 1, 1994
This report identifies fundamental considerations to be taken into account in developing standards to ensure the safety of medical electrical equipment. NOTE - This report follows closely...
This document references:
ISO 10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Published by ISO on August 1, 2018
This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on the...
This document references:
ISO 10993-2 - Biological evaluation of medical devices Part 2: Animal welfare requirements
Published by ISO on July 15, 2006
This part of ISO 10993 is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical...
This document references:
ISO 10993-3 - Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
Published by ISO on October 1, 2014
This part of ISO 10993 specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially...
This document references:
ISO/IEC GUIDE 51 - Safety aspects - Guidelines for their inclusion in standards
Published by ISO on April 1, 2014
This Guide provides requirements and recommendations for the drafters of standards for the inclusion of safety aspects in standards. It is applicable to any safety aspect related to people, property...
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