IEC 60731:2011+AMD1:2016 CSV
Current
The latest, up-to-date edition.
Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy
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08-04-2016
IEC 60731:2011+A1:2016 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. This consolidated version consists of the sixth edition (2011) and its amendment 1 (2016). Therefore, no need to order amendment in addition to this publication.
Committee |
TC 62/SC 62C
|
DevelopmentNote |
Stability Date: 2021. (04/2016)
|
DocumentType |
Standard
|
Pages |
407
|
PublisherName |
International Electrotechnical Committee
|
Status |
Current
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Supersedes |
Standards | Relationship |
NF EN 60731 : 2012 | Identical |
NEN EN IEC 60731 : 2012 | Identical |
PN EN 60731 : 2012 | Identical |
CEI EN 60731 : 2012 | Identical |
EN 60731:2012 | Identical |
OVE/ONORM EN 60731 : 2015 | Identical |
SN EN 60731 : 1997 | Identical |
CEI 62-33 : 1ED 1990 | Identical |
DIN 6817:1984-10 | Corresponds |
GOST R IEC 60731 : 2001 | Identical |
IEC 60601-2-68:2014 | 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 |
03/311965 DC : DRAFT AUG 2003 | BS EN 61267 - MEDICAL DIAGNOSTIC X-RAY EQUIPMENT - RADIATION CONDITIONS FOR USE IN THE DETERMINATION OF CHARACTERISTICS |
BS EN 62467-1:2015 | Medical electrical equipment. Dosimetric instruments as used in brachytherapy Instruments based on well-type ionization chambers |
10/30217545 DC : 0 | BS EN 61674 - MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AND/OR SEMI-CONDUCTOR DETECTORS AS USED IN X-RAY DIAGNOSTIC IMAGING |
07/30152116 DC : 0 | BS EN 62467-1 - MEDICAL ELECTRICAL EQUIPMENT - DOSIMETRIC INSTRUMENTS AS USED IN BRACHYTHERAPY - PART 1: INSTRUMENTS BASED ON WELL-TYPE IONIZATION CHAMBERS |
I.S. EN 60580:2000 | MEDICAL ELECTRICAL EQUIPMENT - DOSE AREA PRODUCT METERS |
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 62467-1 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - DOSIMETRIC INSTRUMENTS AS USED IN BRACHYTHERAPY - PART 1: INSTRUMENTS BASED ON WELL-TYPE IONIZATION CHAMBERS |
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)) |
IEC 60601-2-9:1996 | Medical electrical equipment - Part 2: Particular requirements for the safety of patient contact dosemeters used in radiotherapy with electrically connected radiation detectors |
EN 61262-2:1994 | Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 2: Determination of the conversion factor |
EN 62467-1:2015 | Medical electrical equipment - Dosimetric instruments as used in brachytherapy - Part 1: Instruments based on well-type ionization chambers |
DIN EN 60580:2001-12 | Medical electrical equipment - Dose area product meters (IEC 60580:2000); German version EN 60580:2000 |
OIML D 21 : 1990 | SECONDARY STANDARD DOSIMETRY LABORATORIES FOR THE CALIBRATION OF DOSIMETERS USED IN RADIOTHERAPY |
16/30216785 DC : 0 | BS EN 62667 - MEDICAL ELECTRICAL EQUIPMENT - MEDICAL LIGHT ION BEAM EQUIPMENT - PERFORMANCE CHARACTERISTICS |
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 |
I.S. EN IEC 62667:2018 | MEDICAL ELECTRICAL EQUIPMENT - MEDICAL LIGHT ION BEAM EQUIPMENT - PERFORMANCE CHARACTERISTICS |
BS EN 61262-2:1995 | Characteristics of electro-optical X-ray image intensifiers for medical electrical equipment Determination of the conversion factor |
CEI EN 60601-2-9 : 1998 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF PATIENT CONTACT DOSEMETERS USED IN RADIOTHERAPY WITH ELECTRICALLY CONNECTED RADIATION DETECTORS |
IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
I.S. EN 61267:2006 | MEDICAL DIAGNOSTIC X-RAY EQUIPMENT - RADIATION CONDITIONS FOR USE IN THE DETERMINATION OF CHARACTERISTICS |
BS EN 61674:2013 | Medical electrical equipment. Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging |
CSA C22.2 No. 60601.2.9 : 0 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF PATIENT CONTACT DOSEMETERS USED IN RADIOTHERAPY WITH ELECTRICALLY CONNECTED RADIATION DETECTORS |
BS EN IEC 62667:2018 | Medical electrical equipment. Medical light ion beam equipment. Performance characteristics |
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 |
CSA C22.2 No. 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 |
PD IEC TR 60788:2004 | Medical electrical equipment. Glossary of defined terms |
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 |
CEI EN 61674 : 2014 | MEDICAL ELECTRICAL EQUIPMENT - DOSIMETERS WITH IONIZATION CHAMBERS AND/OR SEMI-CONDUCTOR DETECTORS AS USED IN X-RAY DIAGNOSTIC IMAGING |
EN IEC 62667:2018 | Medical electrical equipment - Medical light ion beam equipment - Performance characteristics |
IEC PAS 61910-1:2007 | Medical electrical equipment - Radiation dose documentation - Part 1: Equipment for radiography and radioscopy |
I.S. EN 61262-2:1995 | MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS OF ELECTRO-OPTICAL X-RAY IMAGE INTENSIFIERS - PART 2: DETERMINATION OF THE CONVERSION FACTOR |
EN 60580:2000 | Medical electrical equipment - Dose area product meters |
BS EN 61267:2006 | Medical diagnostic X-ray equipment. Radiation conditions for use in the determination of characteristics |
IEC 60580:2000 | Medical electrical equipment - Dose area product meters |
IEC 61267:2005 | Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics |
IEC 61674:2012 | Medical electrical equipment - Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging |
EN 60601-2-9:1996/corrigendum:1996 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF PATIENT CONTACT DOSEMETERS USED IN RADIOTHERAPY WITH ELECTRICALLY CONNECTED RADIATION DETECTORS |
BS EN 60580:2000 | Dose area product meters |
BS EN 60601-2-9:1997 | Medical electrical equipment. Particular requirements for safety Specification for patient contact dosemeters used in radiotherapy with electrically connected radiation detectors |
CEI EN 61267 : 2006 | MEDICAL DIAGNOSTIC X-RAY EQUIPMENT - RADIATION CONDITIONS FOR USE IN THE DETERMINATION OF CHARACTERISTICS |
I.S. EN 62467-1:2015 | MEDICAL ELECTRICAL EQUIPMENT - DOSIMETRIC INSTRUMENTS AS USED IN BRACHYTHERAPY - PART 1: INSTRUMENTS BASED ON WELL-TYPE IONIZATION CHAMBERS |
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 |
NF 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 60601-2-9:1998 | MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF PATIENT CONTACT DOSEMETERS USED IN RADIOTHERAPY WITH ELECTRICALLY CONNECTED RADIATION DETECTORS |
IEC 62467-1:2009 | Medical electrical equipment - Dosimetric instruments as used in brachytherapy - Part 1: Instruments based on well-type ionization chambers |
NF EN 60580 : 2004 | MEDICAL ELECTRICAL EQUIPMENT - DOSE AREA PRODUCT METERS |
EN 61674:2013 | Medical electrical equipment - Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging |
EN 61267:2006 | Medical diagnostic X-ray equipment - Radiation conditions for use in the determination of characteristics |
IEC 60051-1:2016 | Direct acting indicating analogue electrical measuring instruments and their accessories - Part 1: Definitions and general requirements common to all parts |
IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
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 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 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 |
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