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    I.S. CEN TS 15260:2006

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    HEALTH INFORMATICS - CLASSIFICATION OF SAFETY RISKS FROM HEALTH INFORMATICS PRODUCTS

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  08-12-2017

    Language(s):  English

    Published date:  10-05-2006

    Publisher:  National Standards Authority of Ireland

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Abbreviated terms
    5 Principles of hazard and risk analysis
    6 Assignment of a risk class to a health informatics product
    7 The analytical process
    8 Examples of assignment of risk classes to products
    9 Relationship of risk classes to design and control of
      production of products
    Annex A (informative) Health informatics products and
            medical devices: rationale
    Annex B (informative) Examples of assignment of Risk Classes
    Annex C (informative) Illustration of the nature of the
            relationship between risk classes and potential
            controls for risk management
    Bibliography

    Abstract - (Show below) - (Hide below)

    Pertains to hazards and risks which could cause harm to a patient. Other risks such as financial or organisational are out of scope unless they have the potential to harm a patient.

    General Product Information - (Show below) - (Hide below)

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Withdrawn

    Standards Referencing This Book - (Show below) - (Hide below)

    IEC 61508-5:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 5: Examples of methods for the determination of safety integrity levels (see Functional Safety and IEC 61508)
    IEC 61508-4:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 4: Definitions and abbreviations (see Functional Safety and IEC 61508)
    IEC 61508-3:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 3: Software requirements (see Functional Safety and IEC 61508)
    ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
    ISO/IEC Guide 73:2002 Risk management Vocabulary Guidelines for use in standards
    ISO/IEC 17799:2005 Information technology Security techniques Code of practice for information security management
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    IEC 61508-6:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 6: Guidelines on the application of IEC 61508-2 and IEC 61508-3 (see Functional Safety and IEC 61508)
    IEC 61508-1:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 1: General requirements (see Functional Safety and IEC 61508)
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    IEC 61508-7:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 7: Overview of techniques and measures (see Functional Safety and IEC 61508)
    IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
    IEC 61508-2:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 2: Requirements for electrical/electronic/programmable electronic safety-related systems (see Functional Safety and IEC 61508)
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