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EN 60731:2012

Current

Current

The latest, up-to-date edition.

Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy

Published date

06-04-2012

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FOREWORD
INTRODUCTION
1 Scope and object
2 Normative references
3 Terms and definitions
4 General requirements
5 CHAMBER ASSEMBLY performance requirements
6 MEASURING ASSEMBLY performance requirements
7 STABILITY CHECK DEVICE performance requirements
8 Constructional requirements as related to PERFORMANCE
   CHARACTERISTICS
9 Marking
10 ACCOMPANYING DOCUMENTS
Annex A (informative) - Values, error and UNCERTAINTY
Annex B (normative) - Test equipment for cable microphony
Annex C (normative) - UNCERTAINTY OF MEASUREMENT
Bibliography
Index of defined terms used in this standard
Annex ZA (normative) - Normative references to international
         publications with their corresponding European
         publications

IEC 60731:2011 specifies the performance requirements of radiotherapy dosimeters, intended for the measurement of absorbed dose to water or air kerma (and their rates and spatial distributions) in photon, electron, proton or heavy ion radiation fields as used in radiotherapy. The dose monitoring systems incorporated in radiotherapy treatment machines are not covered by this standard, neither are the re-entrant ionization chambers used for brachytherapy source calibration and constancy check devices. IEC 60731:2011 is applicable to the following types of dosimeter: - a) field-class dosimeters normally used for 1) in vivo skin surface or intracavitary measurements of dose on patients. 2) in vivo skin surface or intracavitary measurements of dose on patients. b) reference-class dosimeters normally used for the calibration of field-class dosimeters; c) scanning-class dosimeters normally used for relative dose distribution measurements with a scanning system such as an automatic water phantom. The object of this standard is: - to establish requirements for a satisfactory level of performance for radiotherapy dosimeters; - to standardize methods for the determination of compliance with this level of performance. Three levels of performance are specified: - a lower level of performance applying to field-class dosimeters; - a higher level of performance applying to reference-class dosimeters; - a specific level of performance applying to scanning-class dosimeters. This third edition cancels and replaces the second edition published in 1997 and its Amendment 1 (2002) and constitutes a technical revision. The technical modifications versus the second edition of this standard concerns performance requirements of radiotherapy dosimeters intended for the measurement of absorbed dose to water or air kerma in heavy ion radiation fields and scanning-class dosimeters normally used for relative dose distribution measurements with a scanning system such as an automatic water phantom.

Committee
CLC/TC 62
DevelopmentNote
Supersedes HD 534. (05/2001) Supersedes UNE 20660. (05/2005)
DocumentType
Standard
PublisherName
European Committee for Standards - Electrical
Status
Current
Supersedes

Standards Relationship
BS EN 60731:2012 Identical
PN EN 60731 : 2012 Identical
SN EN 60731 : 1997 Identical
CEI EN 60731 : 2012 Identical
NEN EN IEC 60731 : 2012 Identical
IEC 60731:2011+AMD1:2016 CSV Identical
I.S. EN 60731:2012 Identical
NBN EN 60731 : 2013 Identical
NF EN 60731 : 2012 Identical
UNE-EN 60731:2012 Identical
PNE-FprEN 60731 Identical

I.S. EN 61674:2013 MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AND/OR SEMICONDUCTOR DETECTORS AS USED IN X-RAY DIAGNOSTIC IMAGING (IEC 61674:2012 (EQV))
BS EN 61674:2013 Medical electrical equipment. Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging
CEI EN 60580 : 2001 MEDICAL ELECTRICAL EQUIPMENT DOSE AREA PRODUCT METERS
BS EN 60601-2-68:2015 Medical electrical equipment Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
S.R. CEN ISO/TS 19397:2018 DETERMINATION OF THE FILM THICKNESS OF COATINGS USING AN ULTRASONIC GAGE (ISO/TS 19397:2015)
DIN 6800-1:2016-08 Procedures of dosimetry with probe-type detectors for photon and electron radiation - Part 1: General
EN 60601-2-68:2015 Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment
I.S. EN 60601-2-68:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT
CEI EN 61674 : 2014 MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AND/OR SEMI-CONDUCTOR DETECTORS AS USED IN X-RAY DIAGNOSTIC IMAGING
I.S. EN 60580:2000 MEDICAL ELECTRICAL EQUIPMENT - DOSE AREA PRODUCT METERS
EN 60580:2000 Medical electrical equipment - Dose area product meters
BS EN 60580:2000 Dose area product meters
CEN ISO/TS 19397:2018 Determination of the film thickness of coatings using an ultrasonic gage (ISO/TS 19397:2015)
EN 61674:2013 Medical electrical equipment - Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging

EN 60601-2-8:2015/A1:2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-8: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF THERAPEUTIC X-RAY EQUIPMENT OPERATING IN THE RANGE 10 KV TO 1 MV (IEC 60601-2-8:2010/A1:2015)
IEC 60051-1:2016 Direct acting indicating analogue electrical measuring instruments and their accessories - Part 1: Definitions and general requirements common to all parts
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)
IEC 61187:1993 Electrical and electronic measuring equipment - Documentation
EN 61267:2006 Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN 61676:2002/A1:2009 MEDICAL ELECTRICAL EQUIPMENT - DOSIMETRIC INSTRUMENTS USED FOR NON-INVASIVE MEASUREMENT OF X-RAY TUBE VOLTAGE IN DIAGNOSTIC RADIOLOGY
IEC TR 60788:2004 Medical electrical equipment - Glossary of defined terms
IEC 60601-2-8:2010+AMD1:2015 CSV Medical electrical equipment - Part 2-8: Particular requirements forthe basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
IEC 60976:2007 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
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
ISO/IEC Guide 99:2007 International vocabulary of metrology Basic and general concepts and associated terms (VIM)
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 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
EN 61187:1994/corrigendum:1995 ELECTRICAL AND ELECTRONIC MEASURING EQUIPMENT - DOCUMENTATION
IEC 61676:2002+AMD1:2008 CSV Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology
EN 60976:2007 Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
IEC 61267:2005 Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics
IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)
ISO 3534-1:2006 Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability

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