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IEC 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Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Available format(s)

Hardcopy , PDF 1 User , 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Superseded date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

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
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

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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