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  • IEC 60601-2-43:2010+AMD1:2017 CSV

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Superseded date:  22-10-2019

    Language(s):  English - French

    Published date:  31-05-2017

    Publisher:  International Electrotechnical Committee

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    Abstract - (Show below) - (Hide below)

    IEC 60601-2-43:2010+A1:2017 establishes particular basic safety and essential performance requirements for the design and manufacture of X ray equipment for radioscopically guided interventional procedures. It specifies information which is to be provided with such interventional X-ray equipment for the assistance of the responsible organization and operator in managing the radiation risk and equipment failure risk arising from these procedures which could affect patients or staff. This second edition cancels and replaces the first edition published in 2000. This particular standard has been revised to provide a complete set of safety requirements for X-ray equipment for radioscopically guided interventional procedures, based on the third edition of IEC 60601-1 and relevant collaterals. The present edition is extended to become a system standard for X-ray equipment designed for the use during interventional procedures using X-ray imaging, whether of prolonged or normal duration. This consolidated version consists of the second edition (2010) and its amendment 1 (2017). Therefore, no need to order amendment in addition to this publication.

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    Committee TC 62/SC 62B
    Development Note Supersedes IEC 60601-2-32. (11/2012) Stability Date: 2019. (06/2017)
    Document Type Standard
    Publisher International Electrotechnical Committee
    Status Superseded
    Superseded By
    Supersedes

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

    16/30342390 DC : 0 BS EN 60601-2-63:2015/AMENDMENT 1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-63: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EXTRA-ORAL X-RAY EQUIPMENT
    BS EN 61910-1:2014 Medical electrical equipment. Radiation dose documentation Radiation dose structured reports for radiography and radioscopy
    06/30107360 DC : 0 IEC 60601-1-3 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD - RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT
    NF EN 61910-1 : 2015 MEDICAL ELECTRICAL EQUIPMENT - RADIATION DOSE DOCUMENTATION -PART 1: RADIATION DOSE STRUCTURED REPORTS FOR RADIOGRAPHY AND RADIOSCOPY
    EN 60601-2-63:2015 Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
    EN 60601-2-65:2013 Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
    IEC 60601-2-46:2016 Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables
    EN 62494-1:2008 Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography
    BS EN 60601-2-65:2013 Medical electrical equipment Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
    IEC 60601-2-46 : 3.0 MEDICAL ELECTRICAL EQUIPMENT - PART 2-46: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OPERATING TABLES
    I.S. EN 60601-2-54:2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY
    I.S. EN 60601-2-65:2013 MEDICAL ELECTRICAL EQUIPMENT - PART 2-65: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL INTRA-ORAL X-RAY EQUIPMENT (IEC 60601-2-65:2012 (EQV))
    I.S. EN 62494-1:2008 MEDICAL ELECTRICAL EQUIPMENT - EXPOSURE INDEX OF DIGITAL X-RAY IMAGING SYSTEMS - PART 1: DEFINITIONS AND REQUIREMENTS FOR GENERAL RADIOGRAPHY
    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
    IEC 60601-2-63:2012+AMD1:2017 CSV Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
    I.S. EN 60601-1-3:2008 MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT
    EN 60601-1-3 : 2008 AMD 11 2016 MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT (IEC 60601-1-3:2008/A1:2013)
    NEMA XR 31:2016 Standard Attributes on X-ray Equipment for Interventional Procedures
    NEMA XR 27:2013 X-ray Equipment for Interventional Procedures User Quality Control Mode
    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 ISO 11073-10418:2014 Health informatics. Personal health device communication Device specialization. International Normalized Ratio (INR) monitor
    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
    I.S. EN 60601-2-63:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-63: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EXTRAORAL X-RAY EQUIPMENT
    I.S. EN 61910-1:2014 MEDICAL ELECTRICAL EQUIPMENT - RADIATION DOSE DOCUMENTATION -PART 1: RADIATION DOSE STRUCTURED REPORTS FOR RADIOGRAPHY AND RADIOSCOPY
    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)
    IEC 61910-1:2014 Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy
    UNE-EN 60601-2-54:2010 Medical electrical equipment -- Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
    16/30342393 DC : 0 BS EN 60601-2-65:2013/A1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-65: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL INTRA-ORAL X-RAY EQUIPMENT
    BS EN 62494-1:2008 Medical electrical equipment. Exposure index of digital X-ray imaging systems Definitions and requirements for general radiography
    PD IEC TR 60788:2004 Medical electrical equipment. Glossary of defined terms
    BS EN ISO 11073-10406:2012 Health informatics. Personal health device communication Device specialization. Basic electrocardiograph (ECG) (1- to 3-lead ECG)
    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)
    17/30341818 DC : 0 BS EN 60601-2-54 ED 1.0/A2 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY
    CSA C22.2 No. 60601-2-63 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-63: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EXTRA-ORAL X-RAY EQUIPMENT
    IEC PAS 61910-1:2007 Medical electrical equipment - Radiation dose documentation - Part 1: Equipment for radiography and radioscopy
    IEC 60601-2-54:2009+AMD1:2015 CSV Medical electrical equipment - Part 2-54: Particular requirementsfor the basic safety and essential performance of X-ray equipmentfor radiography and radioscopy
    IEC 60601-2-65:2012+AMD1:2017 CSV Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
    IEC 60601-1-3:2008+AMD1:2013 CSV Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
    ISO/IEEE 11073-10406:2012 Health informatics — Personal health device communication — Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG)
    IEC 62494-1:2008 Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography
    BS EN 60601-1-3 : 2008 MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT (IEC 60601-1-3:2008)
    I.S. EN 60601-2-65:2013/A1:2020 Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intraoral X-ray equipment (IEC 60601-2-65:2012/A1:2017)
    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)
    CEI EN 62494-1 : 2010 MEDICAL ELECTRICAL EQUIPMENT - EXPOSURE INDEX OF DIGITAL X-RAY IMAGING SYSTEMS - PART 1: DEFINITIONS AND REQUIREMENTS FOR GENERAL RADIOGRAPHY
    13/30258863 DC : 0 BS EN 61910-1 ED 1.0 - MEDICAL ELECTRICAL EQUIPMENT - RADIATION DOSE DOCUMENTATION - PART 1: RADIATION DOSE STRUCTURED REPORTS FOR RADIOGRAPHY AND RADIOSCOPY
    BS EN 60601-2-63:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
    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 60601-2-65 : 2013 MEDICAL ELECTRICAL EQUIPMENT - PART 2-65: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL INTRA-ORAL X-RAY EQUIPMENT
    BS EN 60601-2-54:2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY
    CAN/CSA-C22.2 No. 60601-2-65 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-65: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL INTRA-ORAL X-RAY EQUIPMENT
    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)
    EN 61910-1:2014 Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy
    EN 60601-2-54:2009/A1:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY

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

    IEC 62220-1-1:2015 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-1: Determination of the detective quantum efficiency - Detectors used in radiographic imaging
    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 61910-1:2014 Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy
    CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
    NEMA XR 24-2008 (R2014) PRIMARY USER CONTROLS FOR INTERVENTIONAL ANGIOGRAPHY X-RAY EQUIPMENT
    IEC 60601-2-54:2009+AMD1:2015 CSV Medical electrical equipment - Part 2-54: Particular requirementsfor the basic safety and essential performance of X-ray equipmentfor radiography and radioscopy
    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
    IEC 62220-1:2003 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency
    IEC 60580:2000 Medical electrical equipment - Dose area product meters
    IEC 60601-1-3:2008+AMD1:2013 CSV Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
    IEC TR 62348:2012 Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition
    IEC 60601-2-44:2009+AMD1:2012+AMD2:2016 CSV Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
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