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  • BS EN 60601-1-4:1997

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Medical electrical equipment. General requirements for safety Collateral standard. General requirements for programmable electrical medical systems

    Available format(s):  Hardcopy, PDF

    Superseded date:  30-11-2006

    Language(s):  English

    Published date:  15-04-2001

    Publisher:  British Standards Institution

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

    INTRODUCTION
    SECTION 1: GENERAL
    1 Scope, object and relationship to other standards
      1.201 Scope
      1.202 Object
      1.2039 Relationship to other standards
    SECTION 2: Terminology and definitions
      2.201 Defined terms
      2.202 Degrees of requirements and miscellaneous terms
    6 Identification, marking and documents
      6.8 ACCOMPANYING DOCUMENTS
    SECTION 9: ABNORMAL OPERATION AND FAULT CONDITIONS:
               ENVIRONMENTAL TESTS
    52 Abnormal operation and fault conditions
       52.201 Documentation
       52.202 RISK management plan
       52.203 DEVELOPMENT LIFE-CYCLE
       52.204 RISK management process
       52.205 Qualification of personnel
       52.206 Requirement specification
       52.207 Architecture
       52.208 Design and implementation
       52.209 VERIFICATION
       52.210 VALIDATION
       52.211 Modification
       52.212 Assessment
    Annex AAA (normative) Terminology - Index of defined
              terms
    Annex BBB (informative) Rationale
    Annex CCC (informative) Risk Concepts
    Annex DDD (informative) Development Life-cycle
    Annex EEE (informative) Examples for PEMS/PESS structures
    Annex FFF (informative) Bibliography
    Annex ZA (normative) Normative references to international
             publications with their corresponding European
             publications
    Figures
    201 Content of RISK MANAGEMENT FILE and RISK
          MANAGEMENT SUMMARY
    CCC.1 Risk chart
    CCC.2 RISK management process
    DDD.1 DEVELOPMENT LIFE-CYCLE model for PEMS
    EEE.1 Examples of PEMS/PESS structures

    Abstract - (Show below) - (Hide below)

    Applicable to the safety of medical electrical equipment and medical electrical systems including programmable electronic subsystems (PEMS). Defines requirements for the design process of PEMS and is also the basis of requirements of Particular Standards, which includes serving as a guide to safety requirements for managing and reducing risk.

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

    Committee CH/62/1
    Development Note Also numbered as BS 5724-1.4(1997) and IEC 60601-1-4. (03/2001) Supersedes 94/505432 DC and 98/562192 DC. (05/2005) Inactive for the new design. (05/2011)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    IEC 61025:2006 Fault tree analysis (FTA)
    ISO/IEC 15026:1998 Information technology System and software integrity levels
    IEC 60812:2006 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
    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)
    EN 60601-1-1:2001 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
    IEC TR 60513:1994 Fundamental aspects of safety standards for medical electrical equipment
    ISO/IEC 12119:1994 Information technology Software packages Quality requirements and testing
    EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
    IEC 60880:2006 Nuclear power plants - Instrumentation and control systems important to safety - Software aspects for computer-based systems performing category A functions
    ISO 9001:2015 Quality management systems — Requirements
    EN 29000-3 : 1993 QUALITY MANAGEMENT AND QUALITY ASSURANCE STANDARDS - GUIDELINES FOR THE APPLICATION OF ISO 9001 TO THE DEVELOPMENT, SUPPLY AND MAINTENANCE OF SOFTWARE
    HD 501 : 200S1 MEDICAL RADIOLOGY - TERMINOLOGY
    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)
    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 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical 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)
    ISO 9000-3:1997 Quality management and quality assurance standards Part 3: Guidelines for the application of ISO 9001:1994 to the development, supply, installation and maintenance of computer software
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