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EN 60580:2000

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

Superseded date

04-09-2020

Published date

05-05-2000

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

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

Committee
CLC/TC 62
DevelopmentNote
Supersedes HD 379 (06/2000)
DocumentType
Standard
PublisherName
European Committee for Standards - Electrical
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
OVE/ONORM EN 60580 : 2002 Identical
UNE-EN 60580:2001 Identical
NF EN 60580 : 2004 Identical
IEC 60580:2000 Identical
NBN EN 60580 : 2001 Identical
NEN EN IEC 60580 : 2000 Identical
I.S. EN 60580:2000 Identical
PN EN 60580 : 2002 Identical
SN EN 60580 : 2000 Identical
BS EN 60580:2000 Identical
CEI EN 60580 : 2001 Identical
DIN EN 60580:2001-12 Identical

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

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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