• IEC 60731:2011+AMD1:2016 CSV

    Current The latest, up-to-date edition.

    Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy

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

    Language(s):  English - French

    Published date:  08-04-2016

    Publisher:  International Electrotechnical Committee

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    Abstract - (Show below) - (Hide below)

    IEC 60731:2011+A1:2016 specifies the performance requirements of radiotherapy dosimeters, intended for the measurement of absorbed dose to water or air kerma (and their rates and spatial distributions) in photon, electron, proton or heavy ion radiation fields as used in radiotherapy. The dose monitoring systems incorporated in radiotherapy treatment machines are not covered by this standard, neither are the re-entrant ionization chambers used for brachytherapy source calibration and constancy check devices. IEC 60731:2011 is applicable to the following types of dosimeter:
    a) field-class dosimeters normally used for
    1) in vivo skin surface or intracavitary measurements of dose on patients.
    2) in vivo skin surface or intracavitary measurements of dose on patients.
    b) reference-class dosimeters normally used for the calibration of field-class dosimeters;
    c) scanning-class dosimeters normally used for relative dose distribution measurements with a scanning system such as an automatic water phantom.
    The object of this standard is:
    - to establish requirements for a satisfactory level of performance for radiotherapy dosimeters;
    - to standardize methods for the determination of compliance with this level of performance.
    Three levels of performance are specified:
    - a lower level of performance applying to field-class dosimeters;
    - a higher level of performance applying to reference-class dosimeters;
    - a specific level of performance applying to scanning-class dosimeters.
    This third edition cancels and replaces the second edition published in 1997 and its Amendment 1 (2002) and constitutes a technical revision. The technical modifications versus the second edition of this standard concerns performance requirements of radiotherapy dosimeters intended for the measurement of absorbed dose to water or air kerma in heavy ion radiation fields and scanning-class dosimeters normally used for relative dose distribution measurements with a scanning system such as an automatic water phantom. This consolidated version consists of the sixth edition (2011) and its amendment 1 (2016). Therefore, no need to order amendment in addition to this publication.

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

    Committee TC 62/SC 62C
    Development Note Stability Date: 2021. (04/2016)
    Document Type Standard
    Publisher International Electrotechnical Committee
    Status Current
    Supersedes

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

    IEC 60601-2-68:2014 Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
    03/311965 DC : DRAFT AUG 2003 BS EN 61267 - MEDICAL DIAGNOSTIC X-RAY EQUIPMENT - RADIATION CONDITIONS FOR USE IN THE DETERMINATION OF CHARACTERISTICS
    BS EN 62467-1:2015 Medical electrical equipment. Dosimetric instruments as used in brachytherapy Instruments based on well-type ionization chambers
    10/30217545 DC : 0 BS EN 61674 - MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AND/OR SEMI-CONDUCTOR DETECTORS AS USED IN X-RAY DIAGNOSTIC IMAGING
    07/30152116 DC : 0 BS EN 62467-1 - MEDICAL ELECTRICAL EQUIPMENT - DOSIMETRIC INSTRUMENTS AS USED IN BRACHYTHERAPY - PART 1: INSTRUMENTS BASED ON WELL-TYPE IONIZATION CHAMBERS
    I.S. EN 60580:2000 MEDICAL ELECTRICAL EQUIPMENT - DOSE AREA PRODUCT METERS
    ISO 16142-1:2016 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    CEI EN 62467-1 : 2016 MEDICAL ELECTRICAL EQUIPMENT - DOSIMETRIC INSTRUMENTS AS USED IN BRACHYTHERAPY - PART 1: INSTRUMENTS BASED ON WELL-TYPE IONIZATION CHAMBERS
    I.S. EN 61674:2013 MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AND/OR SEMICONDUCTOR DETECTORS AS USED IN X-RAY DIAGNOSTIC IMAGING (IEC 61674:2012 (EQV))
    IEC 60601-2-9:1996 Medical electrical equipment - Part 2: Particular requirements for the safety of patient contact dosemeters used in radiotherapy with electrically connected radiation detectors
    EN 61262-2:1994 Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 2: Determination of the conversion factor
    EN 62467-1:2015 Medical electrical equipment - Dosimetric instruments as used in brachytherapy - Part 1: Instruments based on well-type ionization chambers
    DIN EN 60580:2001-12 Medical electrical equipment - Dose area product meters (IEC 60580:2000); German version EN 60580:2000
    OIML D 21 : 1990 SECONDARY STANDARD DOSIMETRY LABORATORIES FOR THE CALIBRATION OF DOSIMETERS USED IN RADIOTHERAPY
    16/30216785 DC : 0 BS EN 62667 - MEDICAL ELECTRICAL EQUIPMENT - MEDICAL LIGHT ION BEAM EQUIPMENT - PERFORMANCE CHARACTERISTICS
    BS EN 60601-2-68:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
    I.S. EN IEC 62667:2018 MEDICAL ELECTRICAL EQUIPMENT - MEDICAL LIGHT ION BEAM EQUIPMENT - PERFORMANCE CHARACTERISTICS
    BS EN 61262-2:1995 Characteristics of electro-optical X-ray image intensifiers for medical electrical equipment Determination of the conversion factor
    CEI EN 60601-2-9 : 1998 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF PATIENT CONTACT DOSEMETERS USED IN RADIOTHERAPY WITH ELECTRICALLY CONNECTED RADIATION DETECTORS
    IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
    I.S. EN 61267:2006 MEDICAL DIAGNOSTIC X-RAY EQUIPMENT - RADIATION CONDITIONS FOR USE IN THE DETERMINATION OF CHARACTERISTICS
    BS EN 61674:2013 Medical electrical equipment. Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging
    CSA C22.2 No. 60601.2.9 : 0 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF PATIENT CONTACT DOSEMETERS USED IN RADIOTHERAPY WITH ELECTRICALLY CONNECTED RADIATION DETECTORS
    BS EN IEC 62667:2018 Medical electrical equipment. Medical light ion beam equipment. Performance characteristics
    BS ISO 16142-1:2016 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    CSA C22.2 No. 60601-2-68 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT
    PD IEC TR 60788:2004 Medical electrical equipment. Glossary of defined terms
    DIN 6800-1:2016-08 Procedures of dosimetry with probe-type detectors for photon and electron radiation - Part 1: General
    EN 60601-2-68:2015 Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
    CEI EN 61674 : 2014 MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AND/OR SEMI-CONDUCTOR DETECTORS AS USED IN X-RAY DIAGNOSTIC IMAGING
    EN IEC 62667:2018 Medical electrical equipment - Medical light ion beam equipment - Performance characteristics
    IEC PAS 61910-1:2007 Medical electrical equipment - Radiation dose documentation - Part 1: Equipment for radiography and radioscopy
    I.S. EN 61262-2:1995 MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS OF ELECTRO-OPTICAL X-RAY IMAGE INTENSIFIERS - PART 2: DETERMINATION OF THE CONVERSION FACTOR
    EN 60580:2000 Medical electrical equipment - Dose area product meters
    BS EN 61267:2006 Medical diagnostic X-ray equipment. Radiation conditions for use in the determination of characteristics
    IEC 60580:2000 Medical electrical equipment - Dose area product meters
    IEC 61267:2005 Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics
    IEC 61674:2012 Medical electrical equipment - Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging
    EN 60601-2-9:1996/corrigendum:1996 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF PATIENT CONTACT DOSEMETERS USED IN RADIOTHERAPY WITH ELECTRICALLY CONNECTED RADIATION DETECTORS
    BS EN 60580:2000 Dose area product meters
    BS EN 60601-2-9:1997 Medical electrical equipment. Particular requirements for safety Specification for patient contact dosemeters used in radiotherapy with electrically connected radiation detectors
    CEI EN 61267 : 2006 MEDICAL DIAGNOSTIC X-RAY EQUIPMENT - RADIATION CONDITIONS FOR USE IN THE DETERMINATION OF CHARACTERISTICS
    I.S. EN 62467-1:2015 MEDICAL ELECTRICAL EQUIPMENT - DOSIMETRIC INSTRUMENTS AS USED IN BRACHYTHERAPY - PART 1: INSTRUMENTS BASED ON WELL-TYPE IONIZATION CHAMBERS
    I.S. EN 60601-2-68:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT
    NF EN 60601-2-68 : 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT
    I.S. EN 60601-2-9:1998 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF PATIENT CONTACT DOSEMETERS USED IN RADIOTHERAPY WITH ELECTRICALLY CONNECTED RADIATION DETECTORS
    IEC 62467-1:2009 Medical electrical equipment - Dosimetric instruments as used in brachytherapy - Part 1: Instruments based on well-type ionization chambers
    NF EN 60580 : 2004 MEDICAL ELECTRICAL EQUIPMENT - DOSE AREA PRODUCT METERS
    EN 61674:2013 Medical electrical equipment - Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging
    EN 61267:2006 Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics

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

    IEC 60051-1:2016 Direct acting indicating analogue electrical measuring instruments and their accessories - Part 1: Definitions and general requirements common to all parts
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 60601-2-8:2010+AMD1:2015 CSV Medical electrical equipment - Part 2-8: Particular requirements forthe basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
    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 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
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