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  • IEC 60812:2006

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Superseded date:  31-12-2021

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

    Published date:  25-01-2006

    Publisher:  International Electrotechnical Committee

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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
    Bibliography

    Abstract - (Show below) - (Hide below)

    This International Standard describes Failure Mode and Effects Analysis (FMEA) and Failure Mode, Effects and Criticality Analysis (FMECA), and gives guidance as to how they may be applied to achieve various objectives by: providing the procedural steps necessary to perform analysis; identifying appropriate terms; defining basic principles; providing examples of the necessary worksheets or other tabular forms.

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

    Committee TC 56
    Development Note Stability Date: 2017. (09/2017)
    Document Type Standard
    Publisher International Electrotechnical Committee
    Status Superseded
    Superseded By
    Supersedes

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

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    CEI 56-46 : 2005 DEPENDABILITY MANAGEMENT - PART 3-5: APPLICATION GUIDE - RELIABILITY TEST CONDITIONS AND STATISTICAL TEST PRINCIPLES
    PD IEC/TR 63039:2016 Probabilistic risk analysis of technological systems. Estimation of final event rate at a given initial state
    EN ISO 15378:2017 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)
    BS EN 61427-2:2015 Secondary cells and batteries for renewable energy storage. General requirements and methods of test On-grid applications
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    BS EN 50156-2:2015 Electrical equipment for furnaces and ancillary equipment Requirements for design, development and type approval of safety devices and subsystems
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    BS ISO 16110-1:2007 Hydrogen generators using fuel processing technologies Safety
    DD CEN/TS 13763-27:2003 Explosives for civil uses. Detonators and relays Definitions, methods and requirements for electronic initiation systems
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    I.S. EN 62506:2013 METHODS FOR PRODUCT ACCELERATED TESTING (IEC 62506:2013 (EQV))
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    I.S. EN 62282-6-100:2010 FUEL CELL TECHNOLOGIES - PART 6-100: MICRO FUEL CELL POWER SYSTEMS - SAFETY (IEC 62282-6-100:2010 (EQV))
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    I.S. EN 62628:2012 GUIDANCE ON SOFTWARE ASPECTS OF DEPENDABILITY (IEC 62628:2012 (EQV))
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    AAMI ISO 14971 : 2007 : INC : ERR 1 : 2007 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
    NF ISO 16110-1 : 2009 HYDROGEN GENERATORS USING FUEL PROCESSING TECHNOLOGIES - PART 1: SAFETY
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    CCS GUIDE FOR SAFETY AND RELIABILITY : 2017 GUIDE FOR SAFETY AND RELIABILITY ASSESSMENT FOR SHIPBOARD SOFTWARE
    I.S. EN 60300-3-15:2009 DEPENDABILITY MANAGEMENT - PART 3-15: APPLICATION GUIDE - ENGINEERING OF SYSTEM DEPENDABILITY
    I.S. EN 61165:2006 APPLICATION OF MARKOV TECHNIQUES
    ISO 13379-1:2012 Condition monitoring and diagnostics of machines — Data interpretation and diagnostics techniques — Part 1: General guidelines
    EN ISO 80079-36:2016 Explosive atmospheres - Part 36: Non-electrical equipment for explosive atmospheres - Basic method and requirements (ISO 80079-36:2016)
    DIN EN ISO 14698-1 E : 2004 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - BIOCONTAMINATION CONTROL - PART 1: GENERAL PRINCIPLES AND METHODS
    DIN EN ISO 13849-2:2013-02 SAFETY OF MACHINERY - SAFETY-RELATED PARTS OF CONTROL SYSTEMS - PART 2: VALIDATION (ISO 13849-2:2012)
    UNE-EN ISO 13849-2:2013 Safety of machinery - Safety-related parts of control systems - Part 2: Validation (ISO 13849-2:2012)
    BS EN 12075:1997 Biotechnology. Large scale process and production. Procedures for fermentation and downstream processes
    05/30060689 DC : DRAFT JUN 2005 IEC 62282-3-1 - FUEL CELL TECHNOLOGIES - PART 3-1: STATIONARY FUEL CELL POWER PLANTS - SAFETY
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    IEC 61069-5:2016 Industrial-process measurement, control and automation - Evaluation of system properties for the purpose of system assessment - Part 5: Assessment of system dependability
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    EN 61924-2:2013 Maritime navigation and radiocommunication equipment and systems - Integrated navigation systems - Part 2: Modular structure for INS - Operational and performance requirements, methods of testing and required test results
    EN 1050 : 1996 SAFETY OF MACHINERY - PRINCIPLES FOR RISK ASSESSMENT
    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 50129 : 2003 COR 2010 RAILWAY APPLICATIONS - COMMUNICATION, SIGNALLING AND PROCESSING SYSTEMS - SAFETY RELATED ELECTRONIC SYSTEMS FOR SIGNALLING
    EN 62506 : 2013 METHODS FOR PRODUCT ACCELERATED TESTING (IEC 62506:2013)
    EN 62282-2:2012 Fuel cell technologies - Part 2: Fuel cell modules
    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
    EN 60300-3-12:2011 Dependability management - Part 3-12: Application guide - Integrated logistic support
    EN 60300-3-2 : 2005 Dependability management - Part 3-2: Application guide - Collection of dependability data from the field
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    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
    CR 954-100:1999 Safety of machinery - Safety-related parts of control systems - Part 100: Guide on the use and application of EN 954-1:1996
    EN 12445:2000 Industrial, commercial and garage doors and gates - Safety in use of power operated doors - Test methods
    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 62429:2008 Reliability growth - Stress testing for early failures in unique complex systems
    EN 60825-2:2004/A2:2010 SAFETY OF LASER PRODUCTS - PART 2: SAFETY OF OPTICAL FIBRE COMMUNICATION SYSTEMS (OFCS)
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    DIN EN ISO 14698-1:2004-04 Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods (ISO 14698-1:2003)
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    IEC 62502:2010 Analysis techniques for dependability - Event tree analysis (ETA)
    IEC 61014:2003 Programmes for reliability growth
    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 62628:2012 Guidance on software aspects of dependability
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    IEC 62198:2013 Managing risk in projects - Application guidelines
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    10/30173705 DC : DRAFT SEP 2010 BS EN 62282-5-1 - FUEL CELL TECHNOLOGIES - PART 5-1: PORTABLE FUEL CELL POWER SYSTEMS - SAFETY
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    UNE-EN 62282-2:2012 Fuel cell technologies - Part 2: Fuel cell modules
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    EN ISO 14644-5:2004 Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2004)
    EN 14143:2013 Respiratory equipment - Self-contained re-breathing diving apparatus
    EN ISO 13408-1:2015 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
    EN ISO 13849-1:2015 Safety of machinery - Safety-related parts of control systems - Part 1: General principles for design (ISO 13849-1:2015)
    EN ISO 13849-2:2012 Safety of machinery - Safety-related parts of control systems - Part 2: Validation (ISO 13849-2:2012)
    EN 1441 : 1997 MEDICAL DEVICES - RISK ANALYSIS
    I.S. EN 50126-1:2017 RAILWAY APPLICATIONS - THE SPECIFICATION AND DEMONSTRATION OF RELIABILITY, AVAILABILITY, MAINTAINABILITY AND SAFETY (RAMS) - PART 1: GENERIC RAMS PROCESS
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    UNE-EN 60300-3-4:2011 Dependability management -- Part 3-4: Application guide - Guide to the specification of dependability requirements
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    IEC TR 62987:2015 Nuclear power plants - Instrumentation and control systems important to safety - Use of Failure Mode and Effects Analysis (FMEA) and related methods to support the justification of systems
    CEI EN 60300-3-1 : 2005 DEPENDABILITY MANAGEMENT - PART 3-1: APPLICATION GUIDE - ANALYSIS TECHNIQUES FOR DEPENDABILITY - GUIDE ON METHODOLOGY
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    BIS IS 15474-3-11 : 2014 DEPENDABILITY MANAGEMENT - PART 3: APPLICATION GUIDE - SECTION 11: RELIABILITY CENTRED MAINTENANCE
    10/30238615 DC : DRAFT NOV 2010 BS EN 62282-3-100 - FUEL CELL TECHNOLOGIES - PART 3-100: STATIONARY FUEL CELL POWER SYSTEMS - SAFETY
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    05/30133969 DC : DRAFT MAY 2005
    PD ISO/TS 17929:2014 Biomechanical effects on amusement ride passengers
    BS IEC 61882:2001 Hazard and operability studies (HAZOP studies). Application guide
    ISO/IEC 15026-1:2013 Systems and software engineering Systems and software assurance Part 1: Concepts and vocabulary
    BS EN 60300-3-11:2009 Dependability management Application guide. Reliability centred maintenance
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    BS 5760-5:1991 Reliability of systems, equipment and components Guide to failure modes, effects and criticality analysis (FMEA and FMECA)
    03/108624 DC : DRAFT JULY 2003 IEC 60300-3-2 - DEPENDABILITY MANAGEMENT - PART 3-2: APPLICATION GUIDE - COLLECTION OF DEPENDABILITY DATA FROM THE FIELD
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    I.S. EN 60300-3-14:2004 DEPENDABILITY MANAGEMENT - PART 3-14: APPLICATION GUIDE - MAINTENANCE AND MAINTENANCE SUPPORT
    S.R. CR 954-100:1999 SAFETY OF MACHINERY - SAFETY-RELATED PARTS OF CONTROL SYSTEMS - PART 100: GUIDE ON THE USE AND APPLICATION OF EN 954-1:1996
    EN 62282-6-100:2010/A1:2012 FUEL CELL TECHNOLOGIES - PART 6-100: MICRO FUEL CELL POWER SYSTEMS - SAFETY (IEC 62282-6-100:2010/A1:2012)
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    Standards Referencing This Book - (Show below) - (Hide below)

    IEC 61025:2006 Fault tree analysis (FTA)
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    IEC 61160:2005 Design review
    IEC 61078:2016 Reliability block diagrams
    IEC 61165:2006 Application of Markov techniques
    AS ISO 22367:2021 Medical laboratories - Application of risk management to medical laboratories
    AS/NZS IEC 31010:2020 Risk management - Risk assessment techniques
    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
    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 Reliability of systems, equipment and components Guide to failure modes, effects and criticality analysis (FMEA and FMECA)
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