• IEC 60580:2000

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    Medical electrical equipment - Dose area product meters

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

    Superseded date:  31-12-2021

    Language(s):  English, English - French, Spanish, Castilian

    Published date:  14-01-2000

    Publisher:  International Electrotechnical Committee

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

    Foreword
    Introduction
    1. Scope and object
    2. Normative references
    3. Terminology and definitions
    4. General requirements
        4.1 Performance requirements
        4.2 Minimum EFFECTIVE RANGES of DOSE AREA PRODUCT
             and DOSE AREA PRODUCT RATE
        4.3 Plane of measurement
        4.4 REFERENCE VALUES and STANDARD TEST CONDITIONS
        4.5 General test conditions
             4.5.1 STANDARD TEST CONDITIONS
             4.5.2 Test of components
             4.5.3 STABILIZATION TIME
             4.5.4 Adjustments during test
             4.5.5 Uniformity of radiation field
        4.6 Statistical fluctuations
        4.7 Uncertainty of measurement
        4.8 Constructional requirements as related to performance
             4.8.1 Display
             4.8.2 Indication of polarizing voltage failure
             4.8.3 Over-ranging
             4.8.4 Indication of reset or other inactive condition
             4.8.5 IONIZATION CHAMBER
        4.9 STABILITY CHECK DEVICE
        4.10 Adjustment
        4.11 Electrical safety
    5. Limits of PERFORMANCE CHARACTERISTICS under STANDARD TEST
        CONDITIONS
        5.1 RELATIVE INTRINSIC ERROR
        5.2 Warning function
        5.3 Repeatability
        5.4 RESOLUTION of reading
        5.5 STABILIZATION TIME
        5.6 Reset on DOSE AREA PRODUCT ranges
        5.7 Drift of INDICATED VALUES
        5.8 Long term stability
        5.9 RESPONSE TIME
        5.10 Spatial uniformity of RESPONSE
    6. LIMITS OF VARIATION for effects of INFLUENCE QUANTITIES
        6.1 Energy dependence of RESPONSE
        6.2 DOSE AREA PRODUCT RATE dependence of DOSE AREA PRODUCT
             measurements
             6.2.1 MEASURING ASSEMBLY
             6.2.2 IONIZATION CHAMBER - Recombination losses
        6.3 IRRADIATION TIME
        6.4 Field size
        6.5 Operating voltage
        6.6 Air pressure
        6.7 Temperature and humidity
        6.8 Air density fluctuation in the IONIZATION CHAMBER
        6.9 Electromagnetic compatibility
             6.9.1 General
             6.9.2 Electrostatic discharge
             6.9.3 Radiated electromagnetic fields
             6.9.4 Conducted disturbances induced by bursts and
                    high frequencies
             6.9.5 Surges
             6.9.6 Voltage dips, short interruptions and voltage
                    VARIATIONS
        6.10 COMBINED STANDARD UNCERTAINTY
    7. Marking
        7.1 MEASURING ASSEMBLY
        7.2 IONIZATION CHAMBER
    8. ACCOMPANYING DOCUMENTS
    Table 1 - Minimum EFFECTIVE RANGES
    Table 2 - REFERENCE VALUES and STANDARD TEST CONDITIONS
    Table 3 - Number of readings required to detect true
              differences delta (95 % confidence level) between
              two sets of instrument readings
    Table 4 - RELATIVE INTRINSIC ERROR, iota
    Table 5 - Maximum values for the COEFFICIENT OF VARIATION Vmax
    Table 6 - LIMITS OF VARIATION for the effects of INFLUENCE
              QUANTITIES
    Table 7 - Example for assessment of the COMBINED STANDARD
              UNCERTAINTY
    Bibliography
    Index of defined terms

    Abstract - (Show below) - (Hide below)

    Specifies the performance and testing of dose area product meters with ionization chambers intended to measure dose area product and/or dose area product rate to which the patient is exposed during medical radiological examinations.The object of this International Standard is1) to establish requirements for a satisfactory level of performance for dose area product meters, and2) to standardize the methods for the determination of compliance with this level of performance.

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

    Committee TC 62/SC 62C
    Development Note Also numbered as BS EN 60580. (10/2005) Stability Date: 2018. (09/2017)
    Document Type Standard
    Publisher International Electrotechnical Committee
    Status Superseded
    Superseded By
    Supersedes

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

    BS EN 62467-1:2015 Medical electrical equipment. Dosimetric instruments as used in brachytherapy Instruments based on well-type ionization chambers
    08/30151689 DC : DRAFT JULY 2008 BS EN 60601-2-43 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES
    NF EN 60601-2-54 : 2009 AMD 1 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-54: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHY AND RADIOSCOPY
    CEI EN 62467-1 : 2016 MEDICAL ELECTRICAL EQUIPMENT - DOSIMETRIC INSTRUMENTS AS USED IN BRACHYTHERAPY - PART 1: INSTRUMENTS BASED ON WELL-TYPE IONIZATION CHAMBERS
    CSA C22.2 No. 60601.2.43 : 2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES
    NF EN 60601-2-43 : 2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR THE SAFETY OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES
    EN 61223-3-1:1999 EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - ACCEPTANCE TESTS - IMAGING PERFORMANCE OF X-RAY EQUIPMENT FOR RADIOGRAPHIC AND RADIOSCOPIC SYSTEMS
    EN 62467-1:2015 Medical electrical equipment - Dosimetric instruments as used in brachytherapy - Part 1: Instruments based on well-type ionization chambers
    NBR IEC 60601-2-43 : 2012 ERRATA 1 2013 MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES
    16/30216785 DC : 0 BS EN 62667 - MEDICAL ELECTRICAL EQUIPMENT - MEDICAL LIGHT ION BEAM EQUIPMENT - PERFORMANCE CHARACTERISTICS
    BS EN 60601-2-43:2010 Medical electrical equipment Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures
    I.S. EN 60976:2007 MEDICAL ELECTRICAL EQUIPMENT - MEDICAL ELECTRON ACCELERATORS - FUNCTIONAL PERFORMANCE CHARACTERISTICS
    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
    IEC 60601-2-43:2010+AMD1:2017 CSV Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
    IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
    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)
    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
    BS EN 60976 : 2008 MEDICAL ELECTRICAL EQUIPMENT - MEDICAL ELECTRON ACCELERATORS - FUNCTIONAL PERFORMANCE CHARACTERISTICS
    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 60976 : 2009 MEDICAL ELECTRICAL EQUIPMENT - MEDICAL ELECTRON ACCELERATORS - FUNCTIONAL PERFORMANCE CHARACTERISTICS
    EN 60601-2-43:2010/A1:2018 MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES (IEC 60601-2-43:2010/A1:2017)
    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
    PD IEC TR 60788:2004 Medical electrical equipment. Glossary of defined terms
    14/30290166 DC : 0 BS ISO 16142-1 - 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
    BS EN IEC 62667:2018 Medical electrical equipment. Medical light ion beam equipment. Performance characteristics
    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
    BS EN 61223-3-1:1999 Evaluation and routine testing in medical imaging departments Acceptance tests - Imaging performance of X-ray equipment for radiographic and radiscopic systems
    I.S. EN IEC 62667:2018 MEDICAL ELECTRICAL EQUIPMENT - MEDICAL LIGHT ION BEAM EQUIPMENT - PERFORMANCE CHARACTERISTICS
    EN IEC 62667:2018 Medical electrical equipment - Medical light ion beam equipment - Performance characteristics
    I.S. EN 60601-2-43:2010 MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES
    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 60976:2007 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
    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
    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 62467-1:2015 MEDICAL ELECTRICAL EQUIPMENT - DOSIMETRIC INSTRUMENTS AS USED IN BRACHYTHERAPY - PART 1: INSTRUMENTS BASED ON WELL-TYPE IONIZATION CHAMBERS
    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. 60601.2.43 : 2011(R2016) MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES
    IEC 61223-3-1:1999 Evaluation and routine testing in medical imaging departments - Part 3-1: Acceptance tests - Imaging performance of X-ray equipment for radiographic and radioscopic systems
    IEC 62467-1:2009 Medical electrical equipment - Dosimetric instruments as used in brachytherapy - Part 1: Instruments based on well-type ionization chambers
    EN 60976:2007 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
    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 61000-4-4 : 3.0EN+(REDLINE+VERSION) ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-4: TESTING AND MEASUREMENT TECHNIQUES - ELECTRICAL FAST TRANSIENT/BURST IMMUNITY TEST
    IEC 60731:2011+AMD1:2016 CSV Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy
    IEC 60950:1999 Safety of information technology equipment
    IEC 61187:1993 Electrical and electronic measuring equipment - Documentation
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 61000-4-11:2004+AMD1:2017 CSV Electromagnetic compatibility (EMC) - Part 4-11: Testing and measurement techniques - Voltage dips, short interruptions and voltage variations immunity tests
    IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
    IEC 61000-4-4:2012 RLV Electromagnetic compatibility (EMC) - Part 4-4: Testing and measurement techniques - Electrical fast transient/burst immunity test
    IEC 61000-4-6 : 4.0 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-6: TESTING AND MEASUREMENT TECHNIQUES - IMMUNITY TO CONDUCTED DISTURBANCES, INDUCED BY RADIO-FREQUENCY FIELDS
    IEC 61000-4-6:2013 Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement techniques - Immunity to conducted disturbances, induced by radio-frequency fields
    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 61000-4-2:2008 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
    IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
    IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
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