IEC/SC 62C - IEC_SC_62C

IEC 60580:2019 is available as IEC 60580:2019 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60580:2019 specifies the performance and testing of Dose Area Product Meters intended to measure Dose Area Product and/or Dose Area Product Rate to which the Patient is exposed during Medical Radiological Examinations. This document is applicable to the following types of Dose Area Product Meters: a) Field-Class Dose Area Product Meters normally used for the measurement of Dose Area Products during Medical Radiological Examinations; b) Reference-Class Dose Area Product Meters normally used for the Calibration of Field-Class Dosimeters. NOTE Reference-Class Dose Area Product Meters can be used as Field-Class Dose Area Product Meters. The object of this document is 1) to establish requirements for a satisfactory level of performance for Dose Area Product Meters, and 2) to standardize the methods for the determination of compliance with this level of performance. Two levels of performance are specified: – a lower level of performance applying to Field-Class Dose Area Product Meters; – a higher level of performance applying to Reference-Class Dose Area Product Meters. IEC 60580:2019 cancels and replaces the second edition published 2000, and constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) a second class of devices is introduced with tighter uncertainty tolerances; b) this document has been expanded to include detectors other than ionization chambers; c) radiation qualities have been updated to the new definitions according to IEC 61267; d) a requirement on the linearity of the dose area product rate measurement was added; e) changed chamber light transmission requirement from 70 % to 60 %.

IEC 62667:2017 applies to light ion beam ME equipment when used, for therapy purposes, in human medical practice. This document applies to light ion beam ME equipment which delivers light ion beams with an energy per nucleon in the range 10 MeV/n to 500 MeV/n. This document describes measurements and test procedures to be performed by the manufacturer of light ion beam ME equipment but does not specify acceptance tests. This document specifies test procedures for the determination and disclosure of performance characteristics, knowledge of which is necessary for proper selection, application, and use of light ion beam ME equipment and which are to be declared in the accompanying documentation together with the greatest deviation or variation to be expected under specific conditions in normal use. A format for presentation of performance values is given in Annex A.

2015-09-16 - IEC inform CCMC that FDIS should be cancelled since the amendment will skip FDIS and go straight to publication

IEC 61675-2:2015 specifies terminology and test methods for describing the characteristics of gamma cameras equipped with parallel hole collimators for planar imaging. This second edition of IEC 61675-2 cancels and replaces the first edition published in 1998 and its Amendment 1 published in 2004, as well as IEC 60789:2005, IEC 60789:2005/COR1:2009, and IEC 61675-3:1998. It has been reformatted, updated, and partly aligned with NEMA NU 1-2007.

IEC 62467-1:2009 specifies the performance and some related constructional requirements of well-type ionization chambers and associated measurement apparatus, intended for the determination of a quantity, such as air kerma strength or reference air kerma rate in photon radiation fields or absorbed dose to water at a depth, in photon and beta radiation fields used in brachytherapy, after appropriate calibration for a given type of source. IEC 62467-1:2009 covers the techniques for the quantification of the quantity appropriate for the brachytherapy source under consideration. This quantity may be air kerma strength or reference air kerma rate at 1 m, or absorbed dose to water at a depth (e.g. 2 mm or 5 mm). Measurement of these quantities may be accomplished by a variety of well-type ionization chambers or systems currently available for this purpose. This standard applies to products intended for low dose rate, high dose rate, intravascular, both photon and beta, brachytherapy measurements. It does not apply to instruments for nuclear medicine applications. The application of the standard is limited to instruments that incorporate well-type ionization chambers as detectors. The intended use is the measurement of the output of radioactive, encapsulated sources for intracavitary (insertion into body cavities) or interstitial (insertion into body tissue) applications. The object of IEC 62467-1:2009 is a) to establish requirements for a satisfactory level of performance for well-type chamber systems, and b) to standardize the methods for the determination of compliance with this level of performance. IEC 62467-1:2009 is not concerned with the safety aspects of well-type chamber systems. The well-type chamber systems covered by this standard are not intended for use in patient environment. The electrical safety of well-type chamber systems is covered in IEC 61010-1. The operation of the electrometer measuring system is covered in IEC 60731.

IEC 60601-2-1:2009 applies to the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV, used for treatment of patients. This particular standard establishes requirements to be complied with by manufacturers in the design and construction of electron accelerators for use in radiotherapy; it does not attempt to define their optimum performance requirements. Its purpose is to identify those features of design that are regarded, at the present time, as essential for the safe operation of such medical electrical equipment. It places limits on the degradation of medical electrical equipment performance beyond which it can be presumed that a fault condition exists and where an interlock then operates to prevent continued operation of the me equipment. This third edition cancels and replaces the second edition published in 1998 and its Amendment 1 (2002). It constitutes a technical revision. This third edition addresses the following issues not covered in previous editions: - alignment with the new relevant collateral standards; - new technologies in radiotherapy, including stereotactic radiosurgery (SRS) and stereotactic radiotherapy (SRT), intensity modulated radiotherapy (IMRT), electronic imaging devices (e.g. EPID) and moving beam radiotherapy (dynamic therapy).

IEC 60601-2-8:2010 establishes particular basic safety and essential performance requirements for therapeutic X-ray equipment with nominal X-ray tube voltages in the range 10 kV to 1 MV when connected to alternating current supply mains. It includes the requirements for accuracy and reproducibility of performance to the extent that these are related to radiation quality and the quantity of ionizing radiation produced and thus must be considered as aspects of safety. This second edition cancels and replaces the first edition of IEC 60601-2-8. This edition constitutes a technical revision which brings this standard in line with the third edition of IEC 60601-1 and its collateral standards.

IEC 60601-2-64:2014 applies to the basic safety and essential performance of Light Ion Beam Medical Electrical equipment, hereafter referred to as ME equipment, used for treatment of patients. This particular standard, with the inclusion of type tests and site tests, applies respectively to the manufacture and some installation aspects of ME equipment intended for radiotherapy in human medical practice, including those in which the selection and display of operating parameters can be controlled automatically by programmable electronic subsystems, that, in normal use, deliver a radiation beam of light ions having energy per nucleon in the range 10 MeV/n to 500 MeV/n. Key words: nuclear medicine, radiation dosimetry.

IEC 60601-2-68:2014 applies to the basic safety and essential performance of X-ray based image-guided radiotherapy (IGRT) equipment for use with External Beam Equipment (EBE). This particular standard covers safety aspects of kilovoltage and megavoltage X-ray imaging devices in a known geometrical relationship with EBE for the purpose of IGRT. It covers aspects of communication and relationships between the EBE and X-ray imaging devices, attached or not directly attached to, but in the same radiation shielded area as, and dedicated for use only with, the EBE. This particular standard deals with equipment for real-time X-IGRT, online X-IGRT and offline X-IGRT. It covers procedures to reduce the risk of over-reliance on the X-IGRT EBE systems. For example the manufacturer will provide an interactive interface for user interaction with the correction suggested by the system.

IEC 60601-2-17:2013 applies to the basic safety and essential performance of automatically-controlled Brachytherapy Afterloading Medical Equipment. This standard does not specify requirements for sealed radioactive sources. This third edition cancels and replaces the second edition, published in 2004. Consideration has been given to new IEC standards, amendments to existing IEC standards, developments in technology and clinical usage, and various hazards encountered and envisaged since the preparation of the first and second editions. This edition constitutes a technical revision which brings this standard in line with IEC 60601-1:2005+A1:2012 and its collateral standards.

IEC 60601-2-11:2013 applies to the basic safety and essential performance of gamma beam therapy equipment, including multi-source stereotactic radiotherapy equipment. This particular standard of the 60601 series, establishes requirements to be complied with by manufacturers in the design and construction of gamma beam therapy equipment. It states tolerance limits beyond which interlocks must prevent, interrupt or terminate irradiation in order to avoid an unsafe condition. Type tests which are performed by the manufacturer, or site tests, which are not necessarily performed by the manufacturer, are specified for each requirement. It does not attempt to define the optimum performance requirements for a gamma beam therapy equipment for use in radiotherapy. Its purpose is to identify those features of design which are regarded at the present time as essential for the safe operation of such equipment. It places limits on the degradation of equipment performance at which it can be presumed that a fault condition applies, e.g. a component failure, and where an interlock then operates to prevent continued operation. This third edition cancels and replaces the second edition of IEC 60601-2-11 published in 1997 and its Amendment 1:2004. This edition constitutes a technical revision which brings this standard in line with the third edition of IEC 60601-1 and its collateral standards.

IEC 61675-1:2013 specifies terminology and test methods for declaring the characteristics of positron emission tomographs. Positron emission tomographs detect the annihilation radiation of positron emitting Radionuclides by coincidence detection. No test has been specified to characterize the uniformity of reconstructed images, because all methods known so far will mostly reflect the noise in the image. This second edition replaces the first edition of IEC 61675-1, published in 1998. This edition constitutes a technical revision. Requirements have been changed regarding the following technical aspects: - spatial resolution; - sensitivity measurement; - scatter fraction; - count rate performance; - and image quality. Keywords: imaging, medical device

IEC 61674:2012 specifies the performance and some related constructional requirements of diagnostic dosimeters intended for the measurement of air kerma, air kerma length product or air kerma rate, in photon radiation fields used in radiography, including mammography, radioscopy and computed tomography, for X-radiation with generating potentials not greater than 150 kV. This International Standard is applicable to the performance of dosimeters with vented ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging. The object of this standard is to establish requirements for a satisfactory level of performance for diagnostic dosimeters, and to standardize the methods for the determination of compliance with this level of performance. This standard is not concerned with the safety aspects of dosimeters. The diagnostic dosimeters covered by this standard are not intended for use in the patient environment and, therefore, the requirements for electrical safety applying to them are contained in IEC 61010-1. This second edition cancels and replaces the first edition and constitutes a technical revision.

IEC 61217:2011 applies to equipment and data related to the process of teleradiotherapy, including patient image data used in relation with radiotherapy treatment planning systems, radiotherapy simulators, isocentric gamma beam therapy equipment, isocentric medical electron accelerators, and non-isocentric equipment when relevant. The object of this standard is to define a consistent set of coordinate systems for use throughout the process of teleradiotherapy, to define the marking of scales (where provided), to define the movements of equipment used in this process, and to facilitate computer control when used. This second edition cancels and replaces the first edition, published in 1996, amendment 1, published in 2000 and amendment 2, published in 2007. This edition constitutes a technical revision to include imager and focus coordinate systems in Subclause 3.12. Beyond this Subclause, changes were only introduced where needed to include the above coordinate systems.

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.

IEC 62083:2009 applies to the design, manufacture and some installation aspects of a radiotherapy treatment planning systems: - for use in radiotherapy treatment planning in human medical practice; - that imports data either through input by the operator or directly from other devices; - that outputs data either in printed form for review or directly to other devices; and which is intended to be: a) for normal use, under the authority of appropriately licensed or qualified persons, by operators having the required skills and training; b) maintained in accordance with the recommendations given in the instructions for use, and c) used within the environmental and electrical supply conditions specified in the technical description. This second edition replaces the first edition of IEC 62083, published in 2000. This edition constitutes a technical revision, which brings this standard in line with changes to the other standards referred to in this standard.

IEC 60601-2-29:2008 establishes requirements to be complied with by manufacturers in the design and construction of radiotherapy simulators; it does not attempt to define their optimum performance requirements. Its purpose is to identify those features of design that are regarded, at the present time, as essential for the safe operation of such medical electrical equipment. It places limits on the degradation of medical electrical equipment performance beyond which it can be presumed that a fault condition exists, for example a component failure, and where an interlock then operates to prevent continued operation of the medical electrical equipment. This third edition cancels and replaces the second edition published in 1999. This edition constitutes a technical revision, which brings this standard in line with the third edition of IEC 60601-1 and its collateral standards.

Applies to medical electron accelerators when used, for therapy purposes, in human medical practice. This standard applies to medical electron accelerators which deliver a radiation beam of either X-radiation or electron radiation with nominal energies in the range 1 MeV to 50 MeV at maximum absorbed dose rates between 0,001 Gy s-1 and 1 Gy s-1 at 1 m from the radiation source and at normal treatment distances between 50 cm and 200 cm from the radiation source. The present standard describes measurements and test procedures to be performed by the manufacturer at the design and construction stage of a medical electron accelerator but does not specify acceptance tests to be performed after installation at the purchaser's site. The accompanying report, IEC 60977, however, does suggest that many of the test procedures are appropriate for acceptance tests. The measurement conditions described in the present standard differ from those previously in use. This applies particularly to the phantom position for measurements and the measurement of distances from the isocentre. These new conditions should be substituted for and not be added to previous methods. This standard specifies test procedures for the determination and disclosure of functional performance characteristics, knowledge of which is deemed necessary for proper application and use of a medical electron accelerator and which are to be declared in the accompanying documents together with the greatest deviation or variation to be expected under specific conditions in normal use. A format for presentation of functional performance values is given in Annex A. It is recognized that inaccuracies in the test methods must be allowed for when assessing performance. However, it was not felt to be advisable to combine the errors into an overall performance tolerance but to keep them separate in the expectation that more accurate test methods will be evolved. It is not intended that this standard should in any way inhibit the future development of new designs of equipment which may have operating modes and parameters different from those described herein, provided that such equipment achieves equivalent levels of performance for the treatment of patients. Except where otherwise stated this standard assumes that the medical electron accelerators have an isocentric gantry. Where the equipment is non-isocentric, the description of performance and test methods may need to be suitably adapted. This second edition cancels and replaces the first edition published in 1989. It constitutes a technical revision. This second edition includes the addition of performance standards and test methods relating to the following new technologies: - dynamic beam delivery techniques, such as moving beam radiotherapy, intensity-modulated radiation therapy (IMRT), image-guided radiotherapy (IGRT) and programmable wedge fields; - stereotactic radiotherapy (SRT) / stereotactic radiosurgery (SRS); - use of electronic imaging devices. This standard, together with IEC TR 60977, should be read in conjunction with IEC 60601-2-1.

IEC 63073-1:2020 specifies terminology and test methods for describing the characteristics of SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY (SPECT) systems designed specifically for tomographic cardiac imaging. This includes dedicated systems or general purpose systems with dedicated sub-systems which are not included in the scope of IEC 61675-2.

This International Standard applies to test procedures which, for the determination of characteristics of systems or components of medical diagnostic X-ray equipment, require well-defined radiation conditions. Except for mammography, this standard does not apply to conditions where discontinuities in radiation absorption of elements are deliberately used to modify properties of the radiation beam (for example by rare earth filters). This standard deals with methods for generating radiation beams with radiation conditions which can be used under test conditions typically found in test laboratories or in manufacturing facilities for the determination of characteristics of medical diagnostic X-ray equipment. Examples of such radiation qualities are radiation beams emerging through the filtration from the X-ray source assembly. radiation conditions represent the more general case, where scattered radiation emerges from an exit surface of a patient or a phantom. This requires a well defined geometrical arrangement.

Applies to the design and manufacture and some installation aspects of a record and verify system (RVS) for use in radiotherapy in human medical practice that a) provides, defines, or displays treatment machine set up data; imports data either through input by the operator or directly from other devices, b) may control the ability of that equipment to operate; c) records data of all treatment sessions; and d) is intended to be: 1) for normal use, under the authority of appropriately licensed or qualified persons, by operators having the required skills and training; 2) maintained in accordance with the recommendations given in the instructions for use; and 3) used within the environmental and electrical supply conditions specified in the technical description.

Specifies the performance requirements of instruments as used in the non-invasive measurement of X-ray tube voltage up to 150 kV and the relevant compliance tests. Describes the method for calibration and gives guidance for estimating the uncertainty in measurements performed under conditions different from those during calibration. This standard is not concerned with the safety aspect of such instruments. The requirements for electrical safety applying to them are contained in EN 60601-1.

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

Covers radionuclide calibrators of the well type, with a gas-filled ionization chamber as used in the practice of nuclear medicine. The object of this Standard is to identify the most important characteristics of radionuclide calibrators and lay down associated test methods to enable manufacturers to declare the characteristics of their devices in a standardized way and facilitate comparisons between devices.

Specifies type tests to be performed by the manufacturer at the design and construction stages of a radiotherapy simulator but does not specify site tests to be performed after installation at the user's site. The accompanying technical report IEC 61170, however, does suggest that many of the test procedures are appropriate for site tests.

Specifies the terminology and test methods for declaring the characteristics of positron emission tomographs. Positron emission tomopgraphs detect the annihilation radiation of positron emission radionuclides by coincidence detection.

Superseded by EN 61217:2012

Specifies particular requirements for the safety of dosimeters used in medical practice in the patient environment for radiotherapy. (Non-medical dosimeters are dealt with in HD 401)

Specifies test methods for declaring the characteristics of Anger type gamma cameras. The latter are composed of a collimator, a detector shield and a radiation detector assembly, together with recording and display devices. It is not within the scope of this standard to address the safety requirements to be followed by manufacturers according to EN 60601-1.

Since IEC 61675-2 was first published in 1998, further developments of single photon computer tomographs allow some of the tomographs to be operated in coincidence detection mode as well. To comply with this trend, this amendment describes test conditions in concordance with the test methods established for dedicated PET systems.

The use of afterloading equipment for brachytherapy purposes may expose patients to danger if the equipment fails to deliver the required dose to the patient, or if the equipment design does not satisfy standards of electrical and mechanical safety. The equipment may also cause danger to persons in the vicinity if the equipment itself fails to contain the radioactive source(s) adequately within the storage container(s) and/or if there are inadequacies in the design of the treatment room. This Particular Standard establishes requirements to be complied with by manufacturers in the design and construction of afterloading equipment for use in temporary brachytherapy procedures. Its purpose is to identify those features of design that are regarded, at the present time, as essential for the safe operation of such equipment. It places limits on the degradation of equipment performance beyond which it can be presumed that a fault condition exists and where an interlock then operates to return the radioactive source(s) to the storage container(s) and afterwards to prevent continued operation of the equipment.

EN following parallel vote

EN following parallel vote * Superseded by EN 60731:2012

EN following parallel vote

EN following parallel vote * Superseded by EN 61217:2012

Applies to the design, manufacture and some installation aspects of an RTPS - for use in RADIOTHERAPY TREATMENT PLANNING in human medical practice; - that imports data either through input by the OPERATOR or direct from other devices; - that outputs data either in printed form for review or direct to other devices; - and which is intended to be . for NORMAL USE, under the authority of appropriately licensed or QUALIFIED PERSONS, by OPERATORS having the required skills and training; . maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, and . used within the environmental and electrical supply conditions SPECIFIED in the technical descriptions. An RTPS is principally a software application, and the object of this standard is to establish the requirements for features, associated documentation, and testing of the software.

EN following parallel vote

Specifies testing and disclosure methods of functional performance of electron accelerators within the 1 MeV to 50 MeV range used for therapy in human and animal medicine. Test procedures to be performed by the manufacturer are also specified. It is recommended to use this standard in conjunction with IEC 60977 and 60601-2-1 which give further guidance on these issues.

Applies to radiotherapy simulators: - that use diagnostic X-ray equipment to simulate physically a therapeutic radiation beam, so that the treatment volume to be subjected to irradiation during radiotherapy can be localized, and the position and size of the radiotherapy radiation field can be confirmed; - intended exclusively for radiotherapy simulation as a prelude to intended radiotherapy, and not for any other purpose such as general diagnostic examinations. Establishes requirements to ensure the ionizing radiation safety and enhanced mechanical and electrical safety of radiotherapy simulators; it identifies geometrical parameters that are critical for the accurate simulation of a radiotherapy treatment.

Establishes requirements to be complied with by manufacturers in the design and construction of electron accelerators for use in radiotherapy and defines type tests and site tests. Places limits on the degradation of equipment performance beyond which it can be presumed that a fault condition exists and where an interlock then operates to prevent continued operation of the equipment.

Specifies test methods for describing the characteristics of gamma camera based wholebody imaging systems. As these systems are based on Anger type gamma cameras this part of EN 61675 should be read in conjunction with EN 60789. The test methods specified have been selected to reflect as much as possible the clinical use of gamma camera based wholebody imaging systems. It is intended that the test methods be carried out by manufacturers, thereby enabling them to describe the characteristics of gamma camera based wholebody imaging systems.

Specifies terminology and test methods for declaring the characteristics of positron emission tomographs. Positron emission tomographs detect the annihilation radiation of positron emitting radionuclides by coincidence detection. It is intended that the test methods be carried out by the manufacturers, thereby enabling them to declare the characteristics of positron emission tomographs. So, the specifications given in the accompanying documents shall be in accordance with this standard.

Specifies terminology and test methods for describing the characteristics of Anger type rotational gamma single photon emission computed tomographs (SPECT), equipped with parallel hole collimators. It is intended that the test methods be carried out by manufacturers thereby enabling them to describe the characteristics of SPECT systems on a common basis.

Specifies the performance and some related constructional requirements of diagnostic dosimeters intended for the measurement of air Kerma, air Kerma length or air Kerma rate, in photon radiation fields used in radiography, including mammography, radioscopy and computed tomography (CT), for X-rays with generating potentials not greater than 150 kV.

Establishes requirements for a satisfactory level of performance of dosimeters with ionization chambers intended for the measurement of absorbed dose to water or air kerma (and their rates) in photon or electron radiation fields as used in radiotherapy. Standardizes methods for the determination of compliance with this level of performance.

This standard specifies requirements for the safety of gamma beam therapy equipment intended for radiotherapy in human medical practice and includes equipment in which the selection and display of operating parameters can be controlled by a programmable electronic system. Applies to equipment which is intended to deliver a gamma radiation beam(s) at normal treatment distances greater than 5 cm using a sealed radioactive source(s). Establishes requirements to ensure the radiation safety and enhance the electrical and mechanical safety of gamma beam therapy equipment used in human medical practice and specifies tests for demonstrating compliance with those requirements.

EN following parallel vote

EN following parallel vote * Superseded by EN 60601-2-29:1999