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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

    Superseded date:  09-04-2020

    Language(s): 

    Published date:  05-05-2000

    Publisher:  European Committee for Standards - Electrical

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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
    Bibliography
    Index of defined terms
    Annex ZA (normative) Normative references to international
                         publications with their corresponding
                         European publications

    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. Establishes requirements for a satisfactory level of performance for dose area product meters. Standardizes the methods for the determination of compliance with this level of performance

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

    Committee CLC/TC 62
    Development Note Supersedes HD 379 (06/2000)
    Document Type Standard
    Publisher European Committee for Standards - Electrical
    Status Superseded
    Superseded By
    Supersedes

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

    I.S. EN 60976:2007 MEDICAL ELECTRICAL EQUIPMENT - MEDICAL ELECTRON ACCELERATORS - FUNCTIONAL PERFORMANCE CHARACTERISTICS
    BS EN 62467-1:2015 Medical electrical equipment. Dosimetric instruments as used in brachytherapy Instruments based on well-type ionization chambers
    I.S. EN IEC 62667:2018 MEDICAL ELECTRICAL EQUIPMENT - MEDICAL LIGHT ION BEAM EQUIPMENT - PERFORMANCE CHARACTERISTICS
    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
    CEI EN 62467-1 : 2016 MEDICAL ELECTRICAL EQUIPMENT - DOSIMETRIC INSTRUMENTS AS USED IN BRACHYTHERAPY - PART 1: INSTRUMENTS BASED ON WELL-TYPE IONIZATION CHAMBERS
    EN 62467-1:2015 Medical electrical equipment - Dosimetric instruments as used in brachytherapy - Part 1: Instruments based on well-type ionization chambers
    BS EN 60601-2-43:2010 Medical electrical equipment Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures
    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
    BS EN 60976 : 2008 MEDICAL ELECTRICAL EQUIPMENT - MEDICAL ELECTRON ACCELERATORS - FUNCTIONAL PERFORMANCE CHARACTERISTICS
    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
    BS 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
    I.S. EN 62467-1:2015 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
    EN 61000-4-11:2004/A1:2017 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-11: TESTING AND MEASUREMENT TECHNIQUES - VOLTAGE DIPS, SHORT INTERRUPTIONS AND VOLTAGE VARIATIONS IMMUNITY TESTS (IEC 61000-4-11:2004/A1:2017)
    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
    EN 60950:2000/corrigendum:2002 SAFETY OF INFORMATION TECHNOLOGY EQUIPMENT
    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
    EN 61000-4-2:2009 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
    EN 60601-1-1:2001 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
    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
    EN 61000-4-3 : 2006 AMD 2 2010 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-3: TESTING AND MEASUREMENT TECHNIQUES - RADIATED, RADIO-FREQUENCY, ELECTROMAGNETIC FIELD IMMUNITY TEST
    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
    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
    EN 60731:2012 Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy
    EN 61187:1994/corrigendum:1995 ELECTRICAL AND ELECTRONIC MEASURING EQUIPMENT - DOCUMENTATION
    HD 501 : 200S1 MEDICAL RADIOLOGY - TERMINOLOGY
    EN 61000-4-4:2012 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-4: TESTING AND MEASUREMENT TECHNIQUES - ELECTRICAL FAST TRANSIENT/BURST IMMUNITY TEST (IEC 61000-4-4:2012)
    EN 61000-4-6:2014/AC:2015 ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-6: TESTING AND MEASUREMENT TECHNIQUES - IMMUNITY TO CONDUCTED DISTURBANCES, INDUCED BY RADIO-FREQUENCY FIELDS (IEC 61000-4-6:2013)
    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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