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  • EN 60812 : 2006

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    ANALYSIS TECHNIQUES FOR SYSTEM RELIABILITY - PROCEDURE FOR FAILURE MODE AND EFFECTS ANALYSIS (FMEA)

    Available format(s): 

    Superseded date:  04-03-2020

    Language(s): 

    Published date:  17-05-2006

    Publisher:  European Committee for Standards - Electrical

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

    FOREWORD
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Overview
      4.1 Introduction
      4.2 Purpose and objectives of the analysis
    5 Failure modes and effects analysis
      5.1 General considerations
      5.2 Preliminary tasks
      5.3 Failure mode, effects, and criticality
          analysis (FMECA)
      5.4 Report of analysis
    6 Other considerations
      6.1 Common-cause failures
      6.2 Human factors
      6.3 Software errors
      6.4 FMEA regarding consequences of system failure
    7 Applications
      7.1 Use of FMEA/FMECA
      7.2 Benefits of FMEA
      7.3 Limitations and deficiencies of FMEA
      7.4 Relationships with other methods
    Annex A (informative) Summary of procedures for FMEA and FMECA
    Annex B (informative) Examples of analyses
    Annex ZA (normative) Normative references to international
                           publications with their corresponding
                           European publications
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines Failure Mode and Effects Analysis (FMEA) and Failure Mode, Effects and Criticality Analysis (FMECA).

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

    Committee SR 56
    Development Note Supersedes HD 485 (05/2006)
    Document Type Standard
    Publisher European Committee for Standards - Electrical
    Status Superseded
    Superseded By
    Supersedes

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

    I.S. EN 50126-1:2017 RAILWAY APPLICATIONS - THE SPECIFICATION AND DEMONSTRATION OF RELIABILITY, AVAILABILITY, MAINTAINABILITY AND SAFETY (RAMS) - PART 1: GENERIC RAMS PROCESS
    16/30339594 DC : DRAFT DEC 2016 BS EN 50129 - RAILWAY APPLICATIONS - COMMUNICATION, SIGNALLING AND PROCESSING SYSTEMS - SAFETY RELATED ELECTRONIC SYSTEMS FOR SIGNALLING
    I.S. EN 60987:2015 NUCLEAR POWER PLANTS - INSTRUMENTATION AND CONTROL IMPORTANT TO SAFETY - HARDWARE DESIGN REQUIREMENTS FOR COMPUTER-BASED SYSTEMS
    BS EN 61869-6 : 2016 INSTRUMENT TRANSFORMERS - PART 6: ADDITIONAL GENERAL REQUIREMENTS FOR LOW-POWER INSTRUMENT TRANSFORMERS
    BS EN 61427-2:2015 Secondary cells and batteries for renewable energy storage. General requirements and methods of test On-grid applications
    17/30348244 DC : 0 BS EN 14594 - RESPIRATORY PROTECTIVE DEVICES - CONTINUOUS FLOW COMPRESSED AIR LINE BREATHING DEVICES - REQUIREMENTS, TESTING AND MARKING
    BS EN 60987:2015 Nuclear power plants. Instrumentation and control important to safety. Hardware design requirements for computer-based systems
    12/30268377 DC : 0 BS EN 50156-2 - ELECTRICAL EQUIPMENT FOR FURNACES AND ANCILLARY EQUIPMENT - PART 2: REQUIREMENTS FOR DESIGN, DEVELOPMENT AND TYPE APPROVAL OF SAFETY DEVICES AND SUBSYSTEMS
    BS EN 62282-5-1:2012 (published 2013-01) Fuel cell technologies Portable fuel cell power systems. Safety
    BS EN 61226:2010 Nuclear power plants. Instrumentation and control important to safety. Classification of instrumentation and control functions
    VDI/VDE 3516-1 : 1978 VALIDATION IN GXP AREA - OPEN-SOURCE SOFTWARE
    BS EN 50156-2:2015 Electrical equipment for furnaces and ancillary equipment Requirements for design, development and type approval of safety devices and subsystems
    UNE-EN 62282-3-1:2011 Fuel cell technologies - Part 3-1: Stationary fuel cell power systems - Safety
    BS EN 61508-7 : 2010 FUNCTIONAL SAFETY OF ELECTRICAL/ELECTRONIC/PROGRAMMABLE ELECTRONIC SAFETY RELATED SYSTEMS - PART 7: OVERVIEW OF TECHNIQUES AND MEASURES
    PREN 50126-1 : DRAFT 2015 RAILWAY APPLICATIONS - THE SPECIFICATION AND DEMONSTRATION OF RELIABILITY, AVAILABILITY, MAINTAINABILITY AND SAFETY (RAMS) - PART 1: GENERIC RAMS PROCESS
    BS EN 62551:2012 (published 2012-11) Analysis techniques for dependability. Petri net techniques
    17/30359208 DC : 0 BS EN 14387 - RESPIRATORY PROTECTIVE DEVICES - GAS FILTER(S) AND COMBINED FILTER(S) - REQUIREMENTS, TESTING, MARKING
    I.S. EN 14593-1:2005 RESPIRATORY PROTECTIVE DEVICES - COMPRESSED AIR LINE BREATHING DEVICES WITH DEMAND VALVE - PART 1: DEVICES WITH A FULL FACE MASK - REQUIREMENTS, TESTING AND MARKING
    BS EN 61165 : 2006 APPLICATION OF MARKOV TECHNIQUES
    VDI/VDE 3528-1 : 2017 REQUIREMENTS OF COMMERCIAL GRADE PRODUCTS AND CRITERIA FOR THEIR USE IN THE INSTRUMENTATION AND CONTROL SYSTEMS IMPORTANT TO SAFETY IN NUCLEAR POWER PLANTS - GENERAL PART
    PREN 50156-2 : DRAFT 2012 ELECTRICAL EQUIPMENT FOR FURNACES AND ANCILLARY EQUIPMENT - PART 2: REQUIREMENTS FOR DESIGN, DEVELOPMENT AND TYPE APPROVAL OF SAFETY DEVICES AND SUBSYSTEMS
    BS EN 60706-2 : 2006 MAINTAINABILITY OF EQUIPMENT - PART 2: MAINTAINABILITY REQUIREMENTS AND STUDIES DURING THE DESIGN AND DEVELOPMENT PHASE
    CEI EN 61869-6 : 1ED 2017 INSTRUMENT TRANSFORMERS - PART 6: ADDITIONAL GENERAL REQUIREMENTS FOR LOW-POWER INSTRUMENT TRANSFORMERS
    CEI EN 60300-3-12 : 2012 DEPENDABILITY MANAGEMENT - PART 3-12: APPLICATION GUIDE - INTEGRATED LOGISTIC SUPPORT
    VDI 4002-2 : 2011 RELIABILITY ENGINEER - REQUIREMENTS FOR QUALIFICATION
    VDI 4003:2007-03 RELIABILITY MANAGEMENT
    BS EN 61025 : 2007 FAULT TREE ANALYSIS (FTA)
    PREN 14387 : DRAFT 2017 RESPIRATORY PROTECTIVE DEVICES - GAS FILTER(S) AND COMBINED FILTER(S) - REQUIREMENTS, TESTING, MARKING
    PREN 14593-1 : DRAFT 2016 RESPIRATORY PROTECTIVE DEVICES - COMPRESSED AIR LINE BREATHING APPARATUS WITH DEMAND VALVE - PART 1: DEVICES WITH A FULL FACE MASK- REQUIREMENTS, TESTING AND MARKING
    17/30348247 DC : 0 BS EN 14593-1 - RESPIRATORY PROTECTIVE DEVICES - COMPRESSED AIR LINE BREATHING APPARATUS WITH DEMAND VALVE - PART 1: DEVICES WITH A FULL FACE MASK - REQUIREMENTS, TESTING AND MARKING
    VDI 4007:2012-06 RELIABILITY GOALS - DETERMINATION, CHECK, REVIEW, CERTIFICATE
    UNE-EN 61882:2017 Hazard and operability studies (HAZOP studies) - Application guide
    BS EN 61882:2016 Hazard and operability studies (HAZOP studies). Application guide
    VDI 4068 Blatt 1:2016-03 Competent persons - Qualification criteria and commissioning
    NF EN 50495 : 2010 SAFETY DEVICES REQUIRED FOR THE SAFE FUNCTIONING OF EQUIPMENT WITH RESPECT TO EXPLOSION RISKS
    VDI 2263 Blatt 7.1:2013-03 DUST FIRES AND DUST EXPLOSIONS - HAZARDS - ASSESSMENT - PROTECTIVE MEASURES - FIRE AND EXPLOSION PROTECTION IN SPRAYING AND DRYING INTEGRATED EQUIPMENT - EXAMPLES
    BS EN 60300-3-11 : 2009 DEPENDABILITY MANAGEMENT - PART 3-11: APPLICATION GUIDE - RELIABILITY CENTRED MAINTENANCE
    BS EN 62619:2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes. Safety requirements for secondary lithium cells and batteries, for use in industrial applications
    BS EN 61162-460 : 2015 MARITIME NAVIGATION AND RADIOCOMMUNICATION EQUIPMENT AND SYSTEMS - DIGITAL INTERFACES - PART 460: MULTIPLE TALKERS AND MULTIPLE LISTENERS - ETHERNET INTERCONNECTION - SAFETY AND SECURITY
    BS EN 60300-3-12 : 2011 DEPENDABILITY MANAGEMENT - PART 3-12: APPLICATION GUIDE - INTEGRATED LOGISTIC SUPPORT
    BS EN 50495 : 2010 SAFETY DEVICES REQUIRED FOR THE SAFE FUNCTIONING OF EQUIPMENT WITH RESPECT TO EXPLOSION RISKS
    BS EN 61907 : 2010 COMMUNICATION NETWORK DEPENDABILITY ENGINEERING
    BS EN 61078:2016 RELIABILITY BLOCK DIAGRAMS
    I.S. EN 50156-2:2015 ELECTRICAL EQUIPMENT FOR FURNACES AND ANCILLARY EQUIPMENT - PART 2: REQUIREMENTS FOR DESIGN, DEVELOPMENT AND TYPE APPROVAL OF SAFETY DEVICES AND SUBSYSTEMS
    EN 62619:2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for secondary lithium cells and batteries, for use in industrial applications
    BS EN 60300-3-15 : 2009 DEPENDABILITY MANAGEMENT - PART 3-15: APPLICATION GUIDE - ENGINEERING OF SYSTEM DEPENDABILITY
    BS EN 62282-3-1 : 2007 FUEL CELL TECHNOLOGIES - PART 3-1: STATIONARY FUEL CELL POWER SYSTEMS - SAFETY
    15/30330403 DC : 0 BS EN 50126-1 - RAILWAY APPLICATIONS - THE SPECIFICATION AND DEMONSTRATION OF RELIABILITY, AVAILABILITY, MAINTAINABILITY AND SAFETY (RAMS) - PART 1: GENERIC RAMS PROCESS
    BS EN 62940:2017 Maritime navigation and radiocommunication equipment and systems. Integrated communication system (ICS). Operational and performance requirements, methods of testing and required test results
    BS EN 60300-3-4:2008 Dependability management Application guide. Guide to the specification of dependability requirements
    CEI EN 60706-2 : 2006 MAINTAINABILITY OF EQUIPMENT - PART 2: MAINTAINABILITY REQUIREMENTS AND STUDIES DURING THE DESIGN AND DEVELOPMENT PHASE
    CEI EN 60300-3-11 : 2011 DEPENDABILITY MANAGEMENT - PART 3-11: APPLICATION GUIDE - RELIABILITY CENTRED MAINTENANCE
    BS EN 62308 : 2006 EQUIPMENT RELIABILITY - RELIABILITY ASSESSMENT METHODS
    CEI EN 50495 : 2011 SAFETY DEVICES REQUIRED FOR THE SAFE FUNCTIONING OF EQUIPMENT WITH RESPECT TO EXPLOSION RISKS
    EN 61078 : 1991 RELIABILITY BLOCK DIAGRAMS (IEC 61078:2016)
    EN 61226 : 2010 NUCLEAR POWER PLANTS - INSTRUMENTATION AND CONTROL IMPORTANT TO SAFETY - CLASSIFICATION OF INSTRUMENTATION AND CONTROL FUNCTIONS
    CEI EN 62308 : 2010 EQUIPMENT RELIABILITY - RELIABILITY ASSESSMENT METHODS
    I.S. EN 62282-5-1:2012 FUEL CELL TECHNOLOGIES - PART 5-1: PORTABLE FUEL CELL POWER SYSTEMS - SAFETY (IEC 62282-5-1:2012 (EQV))
    I.S. EN 50495:2010 SAFETY DEVICES REQUIRED FOR THE SAFE FUNCTIONING OF EQUIPMENT WITH RESPECT TO EXPLOSION RISKS
    I.S. EN 60300-3-11:2009 DEPENDABILITY MANAGEMENT - PART 3-11: APPLICATION GUIDE - RELIABILITY CENTRED MAINTENANCE
    I.S. EN 62282-3-1:2007 FUEL CELL TECHNOLOGIES - PART 3-1: STATIONARY FUEL CELL POWER SYSTEMS - SAFETY
    BS EN 61496-1 : 2013 SAFETY OF MACHINERY - ELECTRO-SENSITIVE PROTECTIVE EQUIPMENT - PART 1: GENERAL REQUIREMENTS AND TESTS
    EN 50126-1:2017 Railway Applications - The Specification and Demonstration of Reliability, Availability, Maintainability and Safety (RAMS) - Part 1: Generic RAMS Process
    I.S. EN 61869-6:2016 INSTRUMENT TRANSFORMERS - PART 6: ADDITIONAL GENERAL REQUIREMENTS FOR LOW-POWER INSTRUMENT TRANSFORMERS
    I.S. EN 61226:2010 NUCLEAR POWER PLANTS - INSTRUMENTATION AND CONTROL IMPORTANT TO SAFETY - CLASSIFICATION OF INSTRUMENTATION AND CONTROL FUNCTIONS
    UNE-EN 60300-3-11:2013 Dependability management -- Part 3-11: Application guide - Reliability centred maintenance
    EN 14593-1:2018 RESPIRATORY PROTECTIVE DEVICES - COMPRESSED AIR LINE BREATHING DEVICES WITH DEMAND VALVE - PART 1: DEVICES WITH A FULL FACE MASK - REQUIREMENTS, TESTING AND MARKING
    EN 14594:2018 RESPIRATORY PROTECTIVE DEVICES - CONTINUOUS FLOW COMPRESSED AIR LINE BREATHING DEVICES - REQUIREMENTS, TESTING AND MARKING
    I.S. EN 14594:2005 RESPIRATORY PROTECTIVE DEVICES - CONTINUOUS FLOW COMPRESSED AIR LINE BREATHING DEVICES - REQUIREMENTS, TESTING AND MARKING
    I.S. EN 60706-2:2006 MAINTAINABILITY OF EQUIPMENT - PART 2: MAINTAINABILITY REQUIREMENTS AND STUDIES DURING THE DESIGN AND DEVELOPMENT PHASE
    PREN 14594 : DRAFT 2016 RESPIRATORY PROTECTIVE DEVICES - CONTINUOUS FLOW COMPRESSED AIR LINE BREATHING DEVICES - REQUIREMENTS, TESTING AND MARKING
    EN 60987 : 2015 NUCLEAR POWER PLANTS - INSTRUMENTATION AND CONTROL IMPORTANT TO SAFETY - HARDWARE DESIGN REQUIREMENTS FOR COMPUTER-BASED SYSTEMS (IEC 60987:2007 + A1:2013)
    I.S. EN 62308:2006 EQUIPMENT RELIABILITY - RELIABILITY ASSESSMENT METHODS
    S.R. CWA 15929:2009 BEST PRACTICES FOR THE DESIGN AND DEVELOPMENT OF CRITICAL INFORMATION SYSTEMS
    I.S. EN 60300-3-12:2011 DEPENDABILITY MANAGEMENT - PART 3-12: APPLICATION GUIDE - INTEGRATED LOGISTIC SUPPORT
    DIN EN 14143:2013-10 RESPIRATORY EQUIPMENT - SELF-CONTAINED RE-BREATHING DIVING APPARATUS
    DIN EN 15233:2007-11 Methodology for functional safety assessment of protective systems for potentially explosive atmospheres
    BS EN 15233 : 2007 METHODOLOGY FOR FUNCTIONAL SAFETY ASSESSMENT OF PROTECTIVE SYSTEMS FOR POTENTIALLY EXPLOSIVE ATMOSPHERES
    BS EN 14143:2013 (published 2013-08) Respiratory equipment. Self-contained re-breathing diving apparatus
    UNE-EN 14143:2014 Respiratory equipment - Self-contained re-breathing diving apparatus
    DIN EN 15233 E : 2007 METHODOLOGY FOR FUNCTIONAL SAFETY ASSESSMENT OF PROTECTIVE SYSTEMS FOR POTENTIALLY EXPLOSIVE ATMOSPHERES
    UNE-EN 60300-3-12:2014 Dependability management - Part 3-12: Application guide - Integrated logistic support
    EN 61496-1:2013/AC:2015 SAFETY OF MACHINERY - ELECTRO-SENSITIVE PROTECTIVE EQUIPMENT - PART 1: GENERAL REQUIREMENTS AND TESTS (IEC 61496-1:2012)
    I.S. EN 14143:2013 RESPIRATORY EQUIPMENT - SELF-CONTAINED RE-BREATHING DIVING APPARATUS
    EN 62282-3-1 : 2007 FUEL CELL TECHNOLOGIES - PART 3-1: STATIONARY FUEL CELL POWER SYSTEMS - SAFETY
    EN 61162-460 : 2015 MARITIME NAVIGATION AND RADIOCOMMUNICATION EQUIPMENT AND SYSTEMS - DIGITAL INTERFACES - PART 460: MULTIPLE TALKERS AND MULTIPLE LISTENERS - ETHERNET INTERCONNECTION - SAFETY AND SECURITY (IEC 61162-460:2015)
    EN 60300-3-12:2011 DEPENDABILITY MANAGEMENT - PART 3-12: APPLICATION GUIDE - INTEGRATED LOGISTIC SUPPORT
    EN 62940 : 2017 MARITIME NAVIGATION AND RADIOCOMMUNICATION EQUIPMENT AND SYSTEMS - INTEGRATED COMMUNICATION SYSTEM (ICS) - OPERATIONAL AND PERFORMANCE REQUIREMENTS, METHODS OF TESTING AND REQUIRED TEST RESULTS (IEC 62940:2016)
    EN 60300-3-15 : 2009 DEPENDABILITY MANAGEMENT - PART 3-15: APPLICATION GUIDE - ENGINEERING OF SYSTEM DEPENDABILITY
    EN 60300-3-4 : 2008 DEPENDABILITY MANAGEMENT - PART 3-4: APPLICATION GUIDE - GUIDE TO THE SPECIFICATION OF DEPENDABILITY REQUIREMENTS
    EN 61869-6 : 2016 INSTRUMENT TRANSFORMERS - PART 6: ADDITIONAL GENERAL REQUIREMENTS FOR LOW-POWER INSTRUMENT TRANSFORMERS (IEC 61869-6:2016)
    EN 61907 : 2010 COMMUNICATION NETWORK DEPENDABILITY ENGINEERING
    EN 61882 : 2016 HAZARD AND OPERABILITY STUDIES (HAZOP STUDIES) - APPLICATION GUIDE (IEC 61882:2016)
    EN 62308 : 2006 EQUIPMENT RELIABILITY - RELIABILITY ASSESSMENT METHODS
    EN 50495 : 2010 SAFETY DEVICES REQUIRED FOR THE SAFE FUNCTIONING OF EQUIPMENT WITH RESPECT TO EXPLOSION RISKS
    EN 61025 : 2007 FAULT TREE ANALYSIS (FTA)
    EN 62551 : 2012 ANALYSIS TECHNIQUES FOR DEPENDABILITY - PETRI NET TECHNIQUES (IEC 62551:2012)
    EN 62282-5-1:2012 FUEL CELL TECHNOLOGIES - PART 5-1: PORTABLE FUEL CELL POWER SYSTEMS - SAFETY (IEC 62282-5-1:2012)
    EN 61508-7:2010 FUNCTIONAL SAFETY OF ELECTRICAL/ELECTRONIC/PROGRAMMABLE ELECTRONIC SAFETY-RELATED SYSTEMS - PART 7: OVERVIEW OF TECHNIQUES AND MEASURES
    EN 60300-3-11 : 2009 DEPENDABILITY MANAGEMENT - PART 3-11: APPLICATION GUIDE - RELIABILITY CENTRED MAINTENANCE
    EN 50156-2 : 2015 ELECTRICAL EQUIPMENT FOR FURNACES AND ANCILLARY EQUIPMENT - PART 2: REQUIREMENTS FOR DESIGN, DEVELOPMENT AND TYPE APPROVAL OF SAFETY DEVICES AND SUBSYSTEMS
    EN 61427-2 : 2015 SECONDARY CELLS AND BATTERIES FOR RENEWABLE ENERGY STORAGE - GENERAL REQUIREMENTS AND METHODS OF TEST - PART 2: ON-GRID APPLICATIONS (IEC 61427-2:2015)
    EN 60706-2 : 2006 MAINTAINABILITY OF EQUIPMENT - PART 2: MAINTAINABILITY REQUIREMENTS AND STUDIES DURING THE DESIGN AND DEVELOPMENT PHASE
    EN 61165 : 2006 APPLICATION OF MARKOV TECHNIQUES
    EN 14143:2013 RESPIRATORY EQUIPMENT - SELF-CONTAINED RE-BREATHING DIVING APPARATUS
    EN 15233:2007 Methodology for functional safety assessment of protective systems for potentially explosive atmospheres
    UNI EN 14143 : 2013 RESPIRATORY EQUIPMENT - SELF-CONTAINED RE-BREATHING DIVING APPARATUS

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

    IEC 61025:2006 Fault tree analysis (FTA)
    SAE ARP 5580 : 2012 RECOMMENDED FAILURE MODES AND EFFECTS ANALYSIS (FMEA) PRACTICES FOR NON-AUTOMOBILE APPLICATIONS
    IEC 61160:2005 Design review
    IEC 61078:2016 Reliability block diagrams
    IEC 61165:2006 Application of Markov techniques
    EN 60300-3-1 : 2004 DEPENDABILITY MANAGEMENT - PART 3-1: APPLICATION GUIDE - ANALYSIS TECHNIQUES FOR DEPENDABILITY - GUIDE ON METHODOLOGY
    EN 61078 : 1991 RELIABILITY BLOCK DIAGRAMS (IEC 61078:2016)
    SAE J 1739 : 2009 POTENTIAL FAILURE MODE AND EFFECTS ANALYSIS IN DESIGN (DESIGN FMEA), POTENTIAL FAILURE MODE AND EFFECTS ANALYSIS IN MANUFACTURING AND ASSEMBLY PROCESSES (PROCESS FMEA)
    IEC 60300-3-1:2003 Dependability management - Part 3-1: Application guide - Analysis techniques for dependability - Guide on methodology
    IEC 60300-1:2014 Dependability management - Part 1: Guidance for management and application
    HD 617 : 200S1 FAULT TREE ANALYSIS (FTA)
    IEC 60300-3-11:2009 Dependability management - Part 3-11: Application guide - Reliability centred maintenance
    IEC 60300-2:2004 Dependability management - Part 2: Guidelines for dependability management
    IEC 60300-3-9:1995 Dependability management - Part 3: Application guide - Section 9: Risk analysis of technological systems
    ISO 9000:2015 Quality management systems Fundamentals and vocabulary
    BS 5760-5(1991) : 1991 RELIABILITY OF SYSTEMS, EQUIPMENT AND COMPONENTS - GUIDE TO FAILURE MODES, EFFECTS AND CRITICALITY ANALYSIS (FMEA AND FMECA)
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