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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Medical electrical equipment - Dose area product meters
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
12-31-2021
English, English - French, Spanish, Castilian
01-14-2000
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
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
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.
Committee |
TC 62/SC 62C
|
DevelopmentNote |
Also numbered as BS EN 60580. (10/2005) Stability Date: 2018. (09/2017)
|
DocumentType |
Standard
|
Pages |
32
|
PublisherName |
International Electrotechnical Committee
|
Status |
Superseded
|
SupersededBy | |
Supersedes |
Standards | Relationship |
OVE/ONORM EN 60580 : 2002 | Identical |
UNE-EN 60580:2001 | Identical |
NF EN 60580 : 2004 | Identical |
GOST IEC 60580 : 2011 | Identical |
HD 379 : 200S1 | Identical |
NEN EN IEC 60580 : 2000 | Identical |
NEN 10580 : 1978 | Identical |
I.S. EN 60580:2000 | Identical |
PN EN 60580 : 2002 | Identical |
AS/NZS 4957:2002 | Identical |
SN EN 60580 : 2000 | Identical |
UNE 20610:1979 | Identical |
CEI EN 60580 : 2001 | Identical |
CEI 62-7 : 1ED 1998 | Identical |
EN 60580:2000 | Identical |
DIN EN 60580:2001-12 | Identical |
GOST R IEC 60580 : 2006 | Identical |
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 |
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 |
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 |
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 |
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 |
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 61000-4-6:2013 | 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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