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  • IEC 60601-2-33:2010+AMD1:2013+AMD2:2015 CSV

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    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):  Hardcopy, PDF 1 User, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Superseded date:  04-08-2022

    Language(s):  English - French

    Published date:  18-06-2015

    Publisher:  International Electrotechnical Committee

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    Abstract - (Show below) - (Hide below)

    IEC 60601-2-33:2010+A1:2013+A2:2015 establishes particular basic safety and essential performance requirements for magnetic resonance equipment to provide protection for the patient and the magnetic resonance worker. It has also been adapted to the third edition of IEC 60601-1 (2005), with technical modifications being introduced where appropriate. The contents of the corrigendum of March 2012 and February 2016 have been included in this copy. This consolidated version consists of the third edition (2010), its amendment 1 (2013) and its amendment 2 (2015). Therefore, no need to order amendments in addition to this publication.

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    Committee TC 62/SC 62B
    Development Note Stability Date: 2017. (06/2015)
    Document Type Standard
    Publisher International Electrotechnical Committee
    Status Superseded
    Superseded By
    Supersedes

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

    CEI EN 62464-1 : 2007 MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL IMAGING - PART 1: DETERMINATION OF ESSENTIAL IMAGE QUALITY PARAMETERS
    09/30177654 DC : 0 BS EN 62570 - MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL IMAGING - INSTRUCTIONS FOR MARKING ITEMS WITHIN THE CONTROLLED ACCESS AREA
    I.S. EN 62570:2015 STANDARD PRACTICE FOR MARKING MEDICAL DEVICES AND OTHER ITEMS FOR SAFETY IN THE MAGNETIC RESONANCE ENVIRONMENT
    AAMI ISO TIR 10974 : 2012 ASSESSMENT OF THE SAFETY OF MAGNETIC RESONANCE IMAGING FOR PATIENTS WITH AN ACTIVE IMPLANTABLE MEDICAL DEVICE
    NF EN 62464-2 : 2011 MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL IMAGING - PART 2: CLASSIFICATION CRITERIA FOR PULSE SEQUENCES
    BS EN ISO 14630:2012 Non-active surgical implants. General requirements
    EN 62570:2015 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
    ASTM F 2978 : 2013 Guide to Optimize Scan Sequences for Clinical Diagnostic Evaluation of Metal-on-Metal Hip Arthroplasty Devices using Magnetic Resonance Imaging
    I.S. EN 62464-2:2011 MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL IMAGING - PART 2: CLASSIFICATION CRITERIA FOR PULSE SEQUENCES
    BS EN 62464-1:2007 Magnetic resonance equipment for medical imaging Determination of essential image quality parameters
    IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
    ISO/IEEE 11073-10418:2014 Health informatics Personal health device communication Part 10418: Device specialization International Normalized Ratio (INR) monitor
    I.S. EN ISO 14630:2012 NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 14630:2012)
    NEMA MS 4:2010 Acoustic Noise Measurement Procedure for Diagnostic Magnetic Resonance Imaging (MRI) Devices
    NEMA PS3.3 : 2017A DIGITAL IMAGING AND COMMUNICATIONS IN MEDICINE (DICOM) - PART 3: INFORMATION OBJECT DEFINITIONS
    NEMA MS 10:2010 Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance Imaging (MRI)
    PD IEC/TR 60601-4-1:2017 Medical electrical equipment Guidance and interpretation. Medical electrical equipment and medical electrical systems employing a degree of autonomy
    BS EN 62570:2015 STANDARD PRACTICE FOR MARKING MEDICAL DEVICES AND OTHER ITEMS FOR SAFETY IN THE MAGNETIC RESONANCE ENVIRONMENT
    ASTM F 2052 : 2015 : REDLINE Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
    BS EN ISO 11073-10418:2014 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10418: DEVICE SPECIALIZATION: INTERNATIONAL NORMALIZED RATIO (INR) MONITOR (ISO/IEEE 11073-10418:2014)
    IEC TR 60601-4-1:2017 Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy
    ASTM F 2503 : 2013 : REDLINE Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
    UNI EN ISO 14630 : 2013 NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    PD IEC TR 60788:2004 Medical electrical equipment. Glossary of defined terms
    BS EN 62464-2:2011 Magnetic resonance equipment for medical imaging Classification criteria for pulse sequences
    I.S. EN ISO 11073-10418:2014 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10418: DEVICE SPECIALIZATION: INTERNATIONAL NORMALIZED RATIO (INR) MONITOR (ISO/IEEE 11073-10418:2014, CORRECTED VERSION 2014-05-01)
    ISO/TS 10974:2012 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
    DIN EN ISO 14630:2013-03 Non-active surgical implants - General requirements (ISO 14630:2012)
    IEC 62464-1:2007 Magnetic resonance equipment for medical imaging - Part 1: Determination of essential image quality parameters
    IEC 62464-2:2010 Magnetic resonance equipment for medical imaging - Part 2: Classification criteria for pulse sequences
    ISO/IEEE 11073-10406:2012 Health informatics Personal health device communication Part 10406: Device specialization Basic electrocardiograph (ECG) (1- to 3-lead ECG)
    IEC 62570:2014 Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
    UNE-EN ISO 14630:2013 Non-active surgical implants - General requirements (ISO 14630:2012)
    EN ISO 11073-10406:2012 Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) (ISO/IEEE 11073-10406:2012)
    EN ISO 14630:2012 Non-active surgical implants - General requirements (ISO 14630:2012)
    BS EN ISO 11073-10406:2012 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG)
    BS PD ISO/TS 10974 : 2012 ASSESSMENT OF THE SAFETY OF MAGNETIC RESONANCE IMAGING FOR PATIENTS WITH AN ACTIVE IMPLANTABLE MEDICAL DEVICE
    I.S. EN ISO 11073-10406:2012 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG) (ISO/IEEE 11073-10406:2012)
    09/30212729 DC : 0 BS EN 62464-2 - MEDICAL ELECTRICAL EQUIPMENT - MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL IMAGING - CLASSIFICATION CRITERIA FOR PULSE SEQUENCES
    UNI EN ISO 11073-10406 : 2013 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG)
    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
    I.S. EN 62464-1:2007 MAGNETIC RESONANCE EQUIPMENT FOR MEDICAL IMAGING - PART 1: DETERMINATION OF ESSENTIAL IMAGE QUALITY PARAMETERS
    ASTM F 2213 : 2017 : REDLINE Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
    EN ISO 11073-10418:2014/AC:2016 Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor - Technical Corrigendum 1 (ISO/IEEE 11073-10418:2014/Cor 1:2016)
    ISO 14630:2012 Non-active surgical implants General requirements
    EN 62464-1:2007 Magnetic resonance equipment for medical imaging - Part 1: Determination of essential image quality parameters
    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
    ASTM F 2503 : 2013 : REDLINE Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
    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
    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
    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
    IEEE C95.6:2002 IEEE STANDARD FOR SAFETY LEVELS WITH RESPECT TO HUMAN EXPOSURE TO ELECTROMAGNETIC FIELDS 0 TO 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)
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