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  • ISO/TR 24971:2013

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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    Medical devices Guidance on the application of ISO 14971

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Withdrawn date:  18-06-2020

    Language(s):  English, Russian

    Published date:  19-06-2013

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO/TR 24971:2013 provides guidance in addressing specific areas of ISO 14971 when implementing risk management. This guidance is intended to assist manufacturers and other users of the standard to understand the role of international product safety and process standards in risk management, develop the policy for determining the criteria for risk acceptability, incorporate production and post-production feedback loop into risk management, differentiate between "information for safety" and "disclosure of residual risk", and evaluate overall residual risk.

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    Document Type Technical Report
    Publisher International Organization for Standardization
    Status Withdrawn
    Superseded By

    Standards Referenced By This Book - (Show below) - (Hide below)

    15/30328959 DC : 0 BS ISO 16142-2 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
    PD IEC/TR 62366-2:2016 Medical devices Guidance on the application of usability engineering to medical devices
    PD ISO/TS 17518:2015 Medical laboratories. Reagents for staining biological material. Guidance for users
    16/30346073 DC : 0 BS ISO 16142-2 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
    ISO/TS 17518:2015 Medical laboratories — Reagents for staining biological material — Guidance for users
    ISO 16142-2:2017 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
    PD IEC/TR 60601-4-1:2017 Medical electrical equipment Guidance and interpretation. Medical electrical equipment and medical electrical systems employing a degree of autonomy
    ANSI/AAMI/ISO 16142-2:2017 MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
    ISO 16142-1:2016 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    BS ISO 16142-1:2016 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    14/30290166 DC : 0 BS ISO 16142-1 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 1: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL NON-IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
    IEC TR 60601-4-1:2017 Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy
    BS ISO 16142-2:2017 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
    IEEE/ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence
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