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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Medical electrical equipment - Dose area product meters
09-04-2020
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 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 61000-4-6:2013 | 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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