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  • EN 60601-2-33:2010/A12:2016

    Current The latest, up-to-date edition.

    MEDICAL ELECTRICAL EQUIPMENT - PART 2-33: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL DIAGNOSIS

    Available format(s): 

    Language(s): 

    Published date:  18-11-2016

    Publisher:  European Committee for Standards - Electrical

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

    INTRODUCTION
    201.1 Scope, object and related standards
    201.2 Normative references
    201.3 Terms and definitions
    201.4 General requirements
    201.5 General requirements for testing of ME EQUIPMENT
    201.6 Classification of ME EQUIPMENT and ME SYSTEMS
    201.7 ME EQUIPMENT identification, marking and documents
    201.8 Protection against electrical HAZARDS from ME EQUIPMENT
    201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME
           SYSTEMS
    201.10 Protection against unwanted and excessive radiation HAZARDS
    201.11 Protection against excessive temperatures and other HAZARDS
    201.12 Accuracy of controls and instruments and protection against
           hazardous outputs
    201.13 HAZARDOUS SITUATIONS and fault conditions
    201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEM (PEMS)
    201.15 Construction of ME EQUIPMENT
    201.16 ME SYSTEMS
    201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
    202 Electromagnetic compatibility - Requirements and tests
    Annexes
    Annex D (informative) - Symbols on marking
    Annex AA (informative) - Particular guidance and rationale
    Bibliography
    Index of defined terms used in this particular standard
    Annex ZA (normative) - Normative references to international
             publications with their corresponding European
             publications
    Annex ZZ (informative) - Coverage of Essential Requirements of EU
             Directives

    Abstract - (Show below) - (Hide below)

    Applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MR EQUIPMENT and MR SYSTEMS, hereafter referred to also as ME EQUIPMENT.

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

    Committee CLC/TC 62
    Document Type Standard
    Publisher European Committee for Standards - Electrical
    Status Current
    Supersedes

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

    EN 62570:2015 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
    I.S. EN 62464-2:2011 MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL IMAGING - PART 2: CLASSIFICATION CRITERIA FOR PULSE SEQUENCES
    BS EN 62570:2015 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
    BS EN 62464-2:2011 Magnetic resonance equipment for medical imaging Classification criteria for pulse sequences
    I.S. EN 62570:2015 STANDARD PRACTICE FOR MARKING MEDICAL DEVICES AND OTHER ITEMS FOR SAFETY IN THE MAGNETIC RESONANCE ENVIRONMENT
    CEI EN 62570 : 2016 STANDARD PRACTICE FOR MARKING MEDICAL DEVICES AND OTHER ITEMS FOR SAFETY IN THE MAGNETIC RESONANCE ENVIRONMENT
    CEI EN 62464-2 : 2012 MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL IMAGING - PART 2: CLASSIFICATION CRITERIA FOR PULSE SEQUENCES
    EN 62464-2:2011 Magnetic resonance equipment for medical imaging - Part 2: Classification criteria for pulse sequences

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

    NEMA MS 8:2016 Characterization of the Specific Absorption Rate (SAR) for Magnetic Resonance Imaging Systems
    ISO 7010:2011 Graphical symbols Safety colours and safety signs Registered safety signs
    IEC 60364-7-710:2002 Electrical installations of buildings - Part 7-710: Requirements for special installations or locations - Medical locations
    CFR 29(PTS1900-1910) : 0 LABOR - OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR
    IEC 62464-1:2007 Magnetic resonance equipment for medical imaging - Part 1: Determination of essential image quality parameters
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
    EN 60601-1-6:2010/A1:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013)
    IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
    IEC 62570:2014 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
    IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    EN 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    ASTM F 2052 : 2015 : REDLINE Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
    NEMA MS 4:2010 Acoustic Noise Measurement Procedure for Diagnostic Magnetic Resonance Imaging (MRI) Devices
    EN 62570:2015 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
    IEEE C95.6-2002 IEEE Standard for Safety Levels With Respect to Human Exposure to Electromagnetic Fields, 0-3 kHz
    EN 45502-2-1:2003 Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
    EN ISO 7010 : 2012 AMD 7 2017 GRAPHICAL SYMBOLS - SAFETY COLOURS AND SAFETY SIGNS - REGISTERED SAFETY SIGNS (ISO 7010:2011/AMD 7:2016)
    EN 60601-1-8:2007/A11:2017 MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS (IEC 60601-1-8:2006/A1:2012)
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