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  • IEC 60300-3-9:1995

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Dependability management - Part 3: Application guide - Section 9: Risk analysis of technological systems

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

    Superseded date:  04-03-2011

    Language(s):  English - French, Spanish, Castilian

    Published date:  18-12-1995

    Publisher:  International Electrotechnical Committee

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

    FOREWORD
    INTRODUCTION
    1 Scope
    2 Normative references
    3 Definitions
    4 Risk analysis concepts
    5 Risk analysis concepts
    6 Audits
    7 Risk analysis methods
    Annex A - Methods for analysis

    Abstract - (Show below) - (Hide below)

    Provides guidelines for selecting and implementing risk analysis techniques. The objective of this standard is to ensure quality and consistency in the planning and execution of risk analyses and the presentation of results and conclusions.

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

    Development Note Also numbered as BS 8444-3(1996) (10/2005)
    Document Type Standard
    Publisher International Electrotechnical Committee
    Status Superseded
    Superseded By

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

    CSA ISO/IEC 15026 : 2001(R2009) INFORMATION TECHNOLOGY - SYSTEM AND SOFTWARE INTEGRITY LEVELS
    06/30123954 DC : DRAFT MAR 2006
    UNE-IEC/TS 62143:2011 Electrical installations for lighting and beaconing of aerodromes - Aeronautical ground lighting systems - Guidelines for the development of a safety lifecycle methodology
    BS EN 31010:2010 Risk management. Risk assessment techniques
    API 689 : 2007 COLLECTION AND EXCHANGE OF RELIABILITY AND MAINTENANCE DATA FOR EQUIPMENT
    BS EN 62502:2011 Analysis techniques for dependability. Event tree analysis (ETA)
    BS EN 60300-3-15:2009 Dependability management Application guide. Engineering of system dependability
    AAMI DF80 : 2003 : R2010 MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE SAFETY OF CARDIAC DEFIBRILLATORS [INCLUDING AUTOMATED EXTERNAL DEFIBRILLATORS]
    CSA ISO/TR 10017 : 2003 : R2013 GUIDANCE ON STATISTICAL TECHNIQUES FOR ISO 9001:2000
    CEI EN 60300-3-2 : 2006 DEPENDABILITY MANAGEMENT - PART 3-2: APPLICATION GUIDE - COLLECTION OF DEPENDABILITY DATA FROM THE FIELD
    CSA ISO 14971 : 2007 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
    CSA ISO/IEC 16085 : 2007 SYSTEMS AND SOFTWARE ENGINEERING - LIFE CYCLE PROCESSES - RISK MANAGEMENT
    SAE J 1211 : 2012 HANDBOOK FOR ROBUSTNESS VALIDATION OF AUTOMOTIVE ELECTRICAL/ELECTRONIC MODULES
    CEI EN 62308 : 2010 EQUIPMENT RELIABILITY - RELIABILITY ASSESSMENT METHODS
    BS EN 62402:2007 Obsolescence management. Application guide
    I.S. EN 60300-3-15:2009 DEPENDABILITY MANAGEMENT - PART 3-15: APPLICATION GUIDE - ENGINEERING OF SYSTEM DEPENDABILITY
    CLC/TR 50126-2:2007 Railway applications - The specification and demonstration of Reliability, Availability, Maintainability and Safety (RAMS) - Part 2: Guide to the application of EN 50126-1 for safety
    EN 62282-3-1 : 2007 FUEL CELL TECHNOLOGIES - PART 3-1: STATIONARY FUEL CELL POWER SYSTEMS - SAFETY
    EN 60300-3-2 : 2005 Dependability management - Part 3-2: Application guide - Collection of dependability data from the field
    EN 62402 : 2007 OBSOLESCENCE MANAGEMENT - APPLICATION GUIDE
    EN 60300-3-15 : 2009 DEPENDABILITY MANAGEMENT - PART 3-15: APPLICATION GUIDE - ENGINEERING OF SYSTEM DEPENDABILITY
    EN 62308 : 2006 EQUIPMENT RELIABILITY - RELIABILITY ASSESSMENT METHODS
    UNE-EN 61508-1:2011 Functional safety of electrical/electronic/programmable electronic safety-related systems -- Part 1: General requirements
    BS EN 61508-1:2010 Functional safety of electrical/electronic/ programmable electronic safety-related systems General requirements
    CEI 56-53 : 2006 DEPENDABILITY MANAGEMENT - PART 3-10: APPLICATION GUIDE - MAINTAINABILITY
    UNE-EN 60300-3-15:2013 Dependability management -- Part 3-15: Application guide - Engineering of system dependability
    BS IEC 60300-3.10 : 2001 DEPENDABILITY MANAGEMENT - PART 3-10: APPLICATION GUIDE - MAINTAINABILITY
    DD IEC/TS 62143:2002 Electrical installations for lighting and beaconing of aerodromes. Aeronautical ground lighting systems. Guidelines for the development of a safety lifecycle methodology
    09/30197014 DC : 0 BS ISO 11231 - SPACE SYSTEMS - PROBABILISTIC RISK ASSESSMENT (PRA)
    BS ISO/IEC/IEEE 29119-2:2013 Software and systems engineering. Software testing Test processes
    06/30160373 DC : 0 BS EN 60601-2-4 ED.3 - MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS
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    12/30236660 DC : 0 BS ISO/IEC 29119-3 - SOFTWARE AND SYSTEMS ENGINEERING - SOFTWARE TESTING - PART 3: TEST DOCUMENTATION
    05/30143452 DC : DRAFT DEC 2005 IEC 61508-1 - FUNCTIONAL SAFETY OF ELECTRICAL/ELECTRONIC/PROGRAMMABLE ELECTRONIC SAFETY - PART 1: GENERAL REQUIREMENTS
    AAMI IEC TIR 80001-2-2 : 2012 APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-2: GUIDANCE FOR THE DISCLOSURE AND COMMUNICATION OF MEDICAL DEVICE SECURITY NEEDS, RISKS AND CONTROLS
    PREN 14973 : DRAFT 2013 CONVEYOR BELTS FOR USE IN UNDERGROUND INSTALLATIONS - ELECTRICAL AND FLAMMABILITY SAFETY REQUIREMENTS
    PD IEC TR 60825-14:2004 Safety of laser products A user\'s guide
    09/30184127 DC : 0 BS EN 61709 - ELECTRONIC COMPONENTS - RELIABILITY - REFERENCE CONDITIONS FOR FAILURE RATES AND STRESS MODELS FOR CONVERSION
    IEEE 15026-3-2013 IEEE Standard Adoption of ISO/IEC 15026-3 -- Systems and Software Engineering -- Systems and Software Assurance -- Part 3: System Integrity Levels
    CSA ISO/IEC 16085 : 2007 : R2012 SYSTEMS AND SOFTWARE ENGINEERING - LIFE CYCLE PROCESSES - RISK MANAGEMENT
    CEI EN 61508-1 : 2011 FUNCTIONAL SAFETY OF ELECTRICAL/ELECTRONIC/PROGRAMMABLE ELECTRONIC SAFETY-RELATED SYSTEMS - PART 1: GENERAL REQUIREMENTS
    BS EN 62308:2006 Equipment reliability. Reliability assessment methods
    CSA ISO 10006 : 2003 QUALITY MANAGEMENT SYSTEMS - GUIDELINES FOR QUALITY MANAGEMENT IN PROJECTS
    CEI EN 62402 : 2008 OBSOLESCENCE MANAGEMENT - APPLICATION GUIDE
    I.S. EN 62282-3-1:2007 FUEL CELL TECHNOLOGIES - PART 3-1: STATIONARY FUEL CELL POWER SYSTEMS - SAFETY
    I.S. EN 60300-3-2:2005 DEPENDABILITY MANAGEMENT - PART 3-2: APPLICATION GUIDE - COLLECTION OF DEPENDABILITY DATA FROM THE FIELD
    AAMI ISO 14971 : 2007 : INC : ERR 1 : 2007 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
    I.S. EN ISO 14971:2012 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007, CORRECTED VERSION 2007-10-01)
    DIN EN ISO 14971:2013-04 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
    BS EN 1441:1998 Medical devices. Risk analysis
    BS EN 340:2003 Protective clothing. General requirements
    VDI 4003:2007-03 Reliability management
    08/30193508 DC : DRAFT NOV 2008 BS EN 61508-1 - FUNCTIONAL SAFETY OF ELECTRICAL/ELECTRONIC/PROGRAMMABLE ELECTRONIC SAFETY-RELATED SYSTEMS - PART 1: GENERAL REQUIREMENTS
    ANSI/AAMI/IEC 60601-2-4:2010/A1:2018 MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS
    04/30066208 DC : DRAFT DEC 2004 ISO 14224 - PETROLEUM AND NATURAL GAS INDUSTRIES - COLLECTION AND EXCHANGE OF RELIABILITY AND MAINTENANCE DATA FOR EQUIPMENT
    CEI EN 62502 : 2012 ANALYSIS TECHNIQUES FOR DEPENDABILITY - EVENT TREE ANALYSIS (ETA)
    CSA CEI/IEC 300.2 : 0 DEPENDABILITY MANAGEMENT - PART 2: DEPENDABILITY PROGRAMME ELEMENTS AND TASKS
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    14/30298039 DC : 0 BS EN 61069-7 ED 2.0 - INDUSTRIAL-PROCESS MEASUREMENT AND CONTROL - EVALUATION OF SYSTEM PROPERTIES FOR THE PURPOSE OF SYSTEM ASSESSMENT - PART 7: ASSESSMENT OF SYSTEM SAFETY HAZARD
    03/118777 DC : DRAFT DEC 2003 IEC 60812 - ANALYSIS TECHNIQUES FOR SYSTEM RELIABILITY - PROCEDURE FOR FAILURE MODE AND EFFECTS ANALYSIS (FMEA)
    04/30114965 DC : DRAFT JUN 2004 EN 14973 - CONVEYOR BELTS FOR USE IN UNDERGROUND INSTALLATIONS - ELECTRICAL AND FLAMMABILITY SAFETY REQUIREMENTS
    02/400715 DC : DRAFT SEP 2002 BS IEC 60300-2 - DEPENDABILITY MANAGEMENT - PART 2: GUIDELINES FOR DEPENDABILITY MANAGEMENT
    ISO 20815:2008 Petroleum, petrochemical and natural gas industries Production assurance and reliability management
    PD CLC/TR 50126-2:2007 Railway applications. The specification and demonstration of reliability, availability, maintainability and safety (RAMS) Guide to the application of EN 50126-1 for safety
    09/30179091 DC : 0 BS ISO 26262-2 - ROAD VEHICLES - FUNCTIONAL SAFETY - PART 2: MANAGEMENT OF FUNCTIONAL SAFETY
    AAMI DF80:2003 MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE SAFETY OF CARDIAC DEFIBRILLATORS [INCLUDING AUTOMATED EXTERNAL DEFIBRILLATORS]
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    CSA ISO/IEC 16085 : 2007 : R2017 SYSTEMS AND SOFTWARE ENGINEERING - LIFE CYCLE PROCESSES - RISK MANAGEMENT
    IEC TR 80001-2-2:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
    I.S. EN ISO 20815:2010 PETROLEUM, PETROCHEMICAL AND NATURAL GAS INDUSTRIES - PRODUCTION ASSURANCE AND RELIABILITY MANAGEMENT
    ISO 11231:2010 Space systems Probabilistic risk assessment (PRA)
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
    ISO/IEC 16085:2006 Systems and software engineering Life cycle processes Risk management
    S.R. CLC/TR 50126-2:2007 RAILWAY APPLICATIONS - THE SPECIFICATION AND DEMONSTRATION OF RELIABILITY, AVAILABILITY, MAINTAINABILITY AND SAFETY (RAMS) - PART 2: GUIDE TO THE APPLICATION OF EN 50126-1 FOR SAFETY
    IEC TS 62143:2002 Electrical installations for lighting and beaconing of aerodromes - Aeronautical ground lighting systems - Guidelines for the development of a safety lifecycle methodology
    EN 60812:2006 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
    IEC 60300-3-15:2009 Dependability management - Part 3-15: Application guide - Engineering of system dependability
    EN 60601-2-4:2011 Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
    EN 31010:2010 Risk management - Risk assessment techniques
    UNE-EN 62282-3-1:2011 Fuel cell technologies - Part 3-1: Stationary fuel cell power systems - Safety
    10/30230297 DC : 0 BS ISO/IEC 15026-3 - SYSTEMS AND SOFTWARE ENGINEERING - SYSTEMS AND SOFTWARE ASSURANCE - PART 3: SYSTEM INTEGRITY LEVELS
    09/30179100 DC : 0 BS ISO 26262-5 - ROAD VEHICLES - FUNCTIONAL SAFETY - PART 5: PRODUCT DEVELOPMENT: HARDWARE LEVEL
    PD IEC/TR 80001-2-2:2012 Application of risk management for IT-networks incorporating medical devices Guidance for the disclosure and communication of medical device security needs, risks and controls
    CEI UNI EN ISO 14971 : 2013 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
    BS ISO/IEC/IEEE 29119-1:2013 Software and systems engineering. Software testing Concepts and definitions
    I.S. EN 62402:2007 OBSOLESCENCE MANAGEMENT - APPLICATION GUIDE
    07/30144128 DC : 0 BS EN 60300-3-15 - DEPENDABILITY MANAGEMENT - PART 3-15: GUIDANCE TO ENGINEERING OF SYSTEM DEPENDABILITY
    CEI EN 60300-3-15 : 2011 DEPENDABILITY MANAGEMENT - PART 3-15: APPLICATION GUIDE - ENGINEERING OF SYSTEM DEPENDABILITY
    CEI EN 60601-2-4 : 2012 MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS
    BS ISO/IEC 16085:2006 Systems and software engineering. Life cycle processes. Risk management
    I.S. EN 31010:2010 RISK MANAGEMENT - RISK ASSESSMENT TECHNIQUES (IEC/ISO 31010:2009 (EQV))
    BS EN 60300-3-2:2005 Dependability management Application guide. Collection of dependability data from the field
    UNI CEI EN ISO 14971 : 2012 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
    CSA ISO 10006 : 2003 : R2013 QUALITY MANAGEMENT SYSTEMS - GUIDELINES FOR QUALITY MANAGEMENT IN PROJECTS
    02/400378 DC : DRAFT APR 2002 ISO/DIS 10006 - QUALITY MANAGEMENT SYSTEMS - GUIDELINES FOR QUALITY MANAGEMENT IN PROJECTS
    09/30169892 DC : 0 BS EN 62502 - ANALYSIS TECHNIQUES FOR DEPENDABILITY - EVENT TREE ANALYSIS
    PD ISO/TR 10017:2003 Guidance on statistical techniques for ISO 9001:2000
    BS EN 60601-2-4:2011 Medical electrical equipment Particular requirements for the basic safety and essential performance of cardiac defibrillators
    I.S. EN 60601-2-4:2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS
    CSA ISO 14971 : 2007 : R2012 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
    AAMI ISO 14971 : 2007 : R2010 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
    BS EN 60812:2006 Analysis techniques for system reliability. Procedure for failure mode and effects analysis (FMEA)
    I.S. EN 61508-1:2010 FUNCTIONAL SAFETY OF ELECTRICAL/ELECTRONIC/PROGRAMMABLE ELECTRONIC SAFETY-RELATED SYSTEMS - PART 1: GENERAL REQUIREMENTS
    IEEE/ISO/IEC 16085-2006 ISO/IEC/IEEE International Standard - Systems and Software Engineering - Life Cycle Processes - Risk Management
    UNI EN ISO 20815 : 2010 PETROLEUM, PETROCHEMICAL AND NATURAL GAS INDUSTRIES - PRODUCTION ASSURANCE AND RELIABILITY MANAGEMENT
    ISO/TR 10017:2003 Guidance on statistical techniques for ISO 9001:2000
    I.S. EN 62502:2010 ANALYSIS TECHNIQUES FOR DEPENDABILITY - EVENT TREE ANALYSIS (ETA)
    I.S. EN 60300-2:2004 DEPENDABILITY MANAGEMENT - PART 2: GUIDELINES FOR DEPENDABILITY MANAGEMENT
    S.R. ISO/TR 10017:2003 GUIDANCE ON STATISTICAL TECHNIQUES FOR ISO 9001:2000
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    EN ISO 20815:2010 Petroleum, petrochemical and natural gas industries - Production assurance and reliability management (ISO 20815:2008, Corrected version 2009-06-15)
    I.S. EN 62308:2006 EQUIPMENT RELIABILITY - RELIABILITY ASSESSMENT METHODS
    I.S. ISO 10006:2005 QUALITY MANAGEMENT - GUIDELINES TO QUALITY MANAGEMENT IN PROJECTS
    IEC 60300-3-10:2001 Dependability management - Part 3-10: Application guide - Maintainability
    IEC 60300-3-2:2004 Dependability management - Part 3-2: Application guide - Collection of dependability data from the field
    IEC 62402:2007 Obsolescence management - Application guide
    IEC 61508-1:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 1: General requirements (see Functional Safety and IEC 61508)
    IEC 62502:2010 Analysis techniques for dependability - Event tree analysis (ETA)
    IEC 60812:2006 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
    IEC 60300-2:2004 Dependability management - Part 2: Guidelines for dependability management
    EN 62502 : 2010 ANALYSIS TECHNIQUES FOR DEPENDABILITY - EVENT TREE ANALYSIS (ETA)
    EN 1441 : 1997 MEDICAL DEVICES - RISK ANALYSIS
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    BS IEC 60300-3.6 : 1997 DEPENDABILITY MANAGEMENT - APPLICATION GUIDE - SOFTWARE ASPECTS OF DEPENDABILITY
    BS EN 62282-3-1:2007 Fuel cell technologies Stationary fuel cell power systems. Safety
    I.S. EN 340:2004 PROTECTIVE CLOTHING - GENERAL REQUIREMENTS
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    BS ISO/IEC/IEEE 29119-3:2013 Software and systems engineering. Software testing Test documentation
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    CSA C22.2 No. 60601.2.4 : 2012 MEDICAL ELECTRICAL EQUIPMENT - PART 2-4: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CARDIAC DEFIBRILLATORS
    CEI 76-11 : 2011 SAFETY OF LASER PRODUCTS - PART 14: A USER'S GUIDE
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    03/108624 DC : DRAFT JULY 2003 IEC 60300-3-2 - DEPENDABILITY MANAGEMENT - PART 3-2: APPLICATION GUIDE - COLLECTION OF DEPENDABILITY DATA FROM THE FIELD
    13/30265319 DC : 0 BS EN 14973 - CONVEYOR BELTS FOR USE IN UNDERGROUND INSTALLATIONS - ELECTRICAL AND FLAMMABILITY SAFETY REQUIREMENTS
    04/30115151 DC : DRAFT JUNE 2004 ISO/IEC 16085 - SOFTWARE ENGINEERING - SOFTWARE LIFE CYCLE PROCESSES - RISK MANAGEMENT
    CSA ISO/TR 10017:2003 GUIDANCE ON STATISTICAL TECHNIQUES FOR ISO 9001:2000
    UNE-EN 62402:2011 Obsolescence management - Application guide
    CSA ISO 14971 : 2007 : R2017 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
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    ISO/IEC/IEEE 29119-2:2013 Software and systems engineering Software testing Part 2: Test processes
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    ISO/IEC/IEEE 29119-3:2013 Software and systems engineering Software testing Part 3: Test documentation
    IEC TR 60825-14:2004 Safety of laser products - Part 14: A user's guide
    ISO/IEC 15026:1998 Information technology System and software integrity levels
    BS ISO 22734-1:2008 Hydrogen generators using water electrolysis process Industrial and commercial applications
    IEC 60601-2-4:2010+AMD1:2018 CSV Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
    ISO 22734-1:2008 Hydrogen generators using water electrolysis process Part 1: Industrial and commercial applications
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    UNE-ISO 22734-1:2012 Hydrogen generators using water electrolysis process. Part 1: Industrial and commercial applications
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