IEC/SC 62B - IEC_SC_62B

IEC 60601-2-37:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ULTRASONIC DIAGNOSTIC EQUIPMENT as defined in 201.3.217, hereinafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 201.7.2.13. This document does not cover ultrasonic therapeutic equipment. Equipment used for the imaging or diagnosis of body structures by ultrasound in conjunction with other medical procedures is covered. IEC 60601-2-37:2024 cancels and replaces the second edition published in 2007 and Amendment 1:2015. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) technical and editorial changes resulting from the amended general standard IEC 60601 1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and its collateral standards IEC 60601-1-xx, b) technical and editorial changes as a result of maintenance to normative references; c) technical and editorial changes resulting from relevant developments in TC 87 Ultrasonics standards. In particular, Clause 201.11 about protection against excessive temperatures and other hazards has been fully revised.

IEC 60601-2-54:2022 is available as IEC 60601-2-54:2022 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-54:2022 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ME EQUIPMENT and ME SYSTEMS intended to be used for projection RADIOGRAPHY and INDIRECT RADIOSCOPY. IEC 60601-2-43 applies to ME EQUIPMENT and ME SYSTEMS intended to be used for interventional applications and refers to applicable requirements in this document. ME EQUIPMENT and ME SYSTEMS intended to be used for bone or tissue absorption densitometry, computed tomography, mammography or dental or radiotherapy applications are excluded from the scope of this document. The scope of this document also excludes radiotherapy simulators. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. IEC 60601-2-54:2022 edition cancels and replaces the first edition published in 2009, Amendment 1:2015 and Amendment 2:2018. This edition constitutes a technical revision. This edition includes editorial and technical changes to reflect the IEC 60601 1:2005/AMD2:2020. It also contains corrections and technical improvements. Significant technical changes with respect to the previous edition are as follows: a) a new specific term DOSIMETER is introduced to replace the general term DOSEMETER; b) terms and definitions taken exclusively from IEC TR 60788:2004 and which are specifically applicable in this document have been moved to 201.3; c) the collateral standards IEC 60601-1-11:2015, IEC 60601-1-11:2015/AMD1:2020, IEC 60601-1-12:2014 and IEC 60601-1-12:2014/AMD1:2020 are applicable if MANUFACTURER so declares; d) the subclause 201.11.101 “Protection against excessive temperatures of X-ray tube assemblies” has been removed from this document as its requirements are sufficiently and clearly covered by IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 and IEC 60601-2-28:2017; e) to adopt changes which are introduced with respect to indicator lights in 7.8.1 of the IEC 60601-1:2005/AMD2:2020 clarification of requirements is provided to avoid conflicts with requirements of indicator lights stipulated for X-RAY EQUIPMENT; f) explanation of the term ESSENTIAL PERFORMANCE is provided in Annex AA to emphasize the performance of the clinical function under NORMAL and SINGLE FAULT CONDITIONS. CONDITIONS.

This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MAGNETIC RESONANCE (MR) EQUIPMENT and MAGNETIC RESONANCE (MR) SYSTEMS. NOTE Where ME EQUIPMENT and ME SYSTEMS are used in the clause headings, this is to be understood to indicate MR EQUIPMENT and MR SYSTEMS. This document does not cover the application of MR EQUIPMENT beyond the INTENDED USE. If a clause or subclause is specifically intended to be applicable to MR EQUIPMENT only, or to MR SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to MR EQUIPMENT and to MR SYSTEMS, as relevant. This document does not formulate additional specific requirements for MR EQUIPMENT or MR SYSTEMS used in INTERVENTIONAL MR EXAMINATIONS.

IEC 61223-3-8:2024 applies to evaluation of the imaging performance and related quality control parameters of X‑ray equipment for radiography and radioscopy that conform to IEC 60601-2-54:2022 or IEC 60601-2-43:2022. This document applies to the evaluation of the imaging performance of the entire imaging chain from image acquisition, image processing and image display. This document applies to acceptance tests and constancy tests, which are part of the quality assurance program in medical imaging departments and are intended to be performed by or under the responsibility of the responsible organization. A detailed discussion of the position of these tests within the medical radiological equipment lifecycle is provided in Clause A.2. The methods included rely mainly on non-invasive measurements that use appropriate test equipment and are performed after the installation is completed in accordance with the manufacturer’s installation instructions. IEC 60601-2-54:2022 and IEC 60601-2-43:2022 require information to be provided to the responsible organization with respect to quality control. This document provides guidance to manufacturers regarding the acceptance and constancy tests for the X‑ray equipment in a manufacturer supplied quality control manual. Annex G provides guidance for such a manual.

IEC 62220-2-1:2023 describes the performance metrics associated with DUAL-ENERGY IMAGING capable DIGITAL X-RAY IMAGING DEVICES meant for medical applications and specifies the methods for their determination. These metrics can be used to analyse TISSUE-SUBTRACTED IMAGES and to evaluate dose performance, noise characteristics, and tissue-subtraction efficacy of DIGITAL X-RAY IMAGING DEVICES. The described methods indicate the procedures to obtain MULTI-SPECTRAL PRIMARY DATA and to compute their derived TISSUE-SUBTRACTED IMAGES. The intended users of this document are MANUFACTURERS and well-equipped test laboratories. This document is restricted to DIGITAL X-RAY IMAGING DEVICES that are used for single or multiple exposure dual-energy radiographic imaging based on, for example, CR systems, direct and indirect flat panel-detector based systems. This document excludes and is not applicable to: – DIGITAL X-RAY IMAGING DEVICES intended to be used in mammography or in dental RADIOGRAPHY; – slot scanning DIGITAL X-RAY IMAGING DEVICES; – COMPUTED TOMOGRAPHY or CONE-BEAM COMPUTED TOMOGRAPHY; – photon-energy discriminating devices such as photon counting X-RAY IMAGING DEVICES; – devices for dynamic imaging (where series of images are acquired, as in fluoroscopy or cardiac imaging). – DIGITAL X-RAY IMAGING DEVICES intended to be used with RADIOTHERAPY beams.

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of both FIXED and MOBILE X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, hereafter referred to as INTERVENTIONAL X-RAY EQUIPMENT. Its scope excludes, in particular: - equipment for RADIOTHERAPY; - equipment for COMPUTED TOMOGRAPHY; - ACCESSORIES intended to be introduced into the PATIENT; - mammographic X-RAY EQUIPMENT; - dental X-RAY EQUIPMENT. NOTE 1 Examples of RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, for which the use of INTERVENTIONAL X-RAY EQUIPMENT complying with this standard is recommended, are given in Annex AA. NOTE 2 Specific requirements for magnetic navigation devices, and for the use of INTERVENTIONAL X-RAY EQUIPMENT in an operating room environment were not considered in this particular standard; therefore no specific requirements have been developed for these devices or uses. In any case, such devices or uses remain under the general clause requirements. NOTE 3 INTERVENTIONAL X-RAY EQUIPMENT, when used for cone-beam CT mode, is covered by this standard and not by IEC 60601-2-44 [2]2. No additional requirements for operation in cone-beam CT mode were identified for this standard (see also Note 4 in 203.6.4.5). INTERVENTIONAL X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, which does not include a PATIENT SUPPORT as part of the system, is exempt from the PATIENT SUPPORT provisions of this standard. If a clause or subclause is specifically intended to be applicable to INTERVENTIONAL X-RAY EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to INTERVENTIONAL X-RAY EQUIPMENT and to ME SYSTEMS, as relevant. NOTE 4 See also 4.2 of the general standard. The subclauses of this standard supersede IEC 60601-2-54 subclauses. IEC 60601-2-54 applies only with regards to the cited subclauses; non-cited subclauses of IEC 60601-2-54 do not apply.

This International Standard is applicable to X-RAY SOURCE ASSEMBLIES and X-RAY TUBE ASSEMBLIES, for use in MEDICAL DIAGNOSTIC RADIOLOGY for techniques in which the X-RAY PATTERN will be received simultaneously in all points of the IMAGE RECEPTION AREA. This standard specifies a method for the determination of the greatest geometrically symmetrical RADIATION FIELD at a specified distance from the FOCAL SPOT for which the percentage AIR KERMA RATE along the major axes of the RADIATION FIELD does not fall below a permitted value. NOTE 1 AIR KERMA or AIR KERMA RATE are the only practical verifiable physical quantities for X-RAY SOURCES. X-RAY SOURCES must be tested independently from MEDICAL ELECTRICAL SYSTEMS. Conversion to the characteristics of the X-RAY IMAGE RECEPTOR used in a MEDICAL ELECTRICAL SYSTEM may be done in addition. In case multiple FOCAL SPOTS are not super-imposed, each focal spot has its own REFERENCE AXIS. Then the maximum RADIATION FIELD may be given for each FOCAL SPOT separately NOTE 2 The maximum symmetrical RADIATION FIELD may change from its initial value as the X-RAY TUBE ages through use. NOTE 3 If, for certain MEDICAL ELECTRICAL SYSTEMs the scope of IEC 60806 does not fit, then the special RADIATION FIELD requirements could be incorporated in the MEDICAL ELECTRICAL SYSTEM particular standard. However, a statement on the RADIATION FIELD while referring IEC 60806 is then no longer possible.

IEC 61223-3-5:2019 applies to CT SCANNERS that conform to IEC 60601-2-44:2009, IEC 60601-2-44:2009/AMD1:2012 and IEC 60601-2-44:2009/AMD1:2012AMD2:2016. IEC 60601-2-44 and this document • defines the essential parameters which describe the performance of CT SCANNERS with regard to image quality, RADIATION OUTPUT and PATIENT positioning; the list of parameters to be tested can be found in section 4.3, • defines the methods of testing the essential parameters, and • evaluates compliance with the tolerances of the parameters SPECIFIED by the ACCOMPANYING DOCUMENTS. The methods defined in IEC 60601-2-44 and this document rely on non-invasive measurements, using appropriate test equipment, performed during or after installation. Signed statements covering steps in the installation procedure can be used as part of the ACCEPTANCE TEST report. This document applies to ACCEPTANCE TESTS and CONSTANCY TESTS on a CT SCANNER. The aim of the ACCEPTANCE TESTS is to verify compliance of the installation or MAJOR SERVICE ACTION with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning. The CONSTANCY TESTS are performed to ensure that the functional performance of EQUIPMENT meets ESTABLISHED CRITERIA and to enable the early recognition of changes in the properties of components of the EQUIPMENT, and to verify compliance with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning. This document also contains requirements associated with ACCEPTANCE and CONSTANCY TESTING for the ACCOMPANYING DOCUMENTS of the CT SCANNER. This document does not apply to • aspects of mechanical and electrical safety, and • aspects of mechanical, electrical and software performance, unless they are essential for performing the ACCEPTANCE TESTS and CONSTANCY TESTS, and are directly affecting image quality, RADIATION OUTPUT and PATIENT positioning. IEC 61223-3-5:2019 cancels and replaces the first edition published in 2004, and the second edition of IEC 61223-2-6 published in 2006. This edition constitutes a technical revision. This edition includes the following significant technical change with respect to the previous edition and to IEC 61223-2-6: 1) modification of the RADIATION protection and control; 2) modification of the acceptance testing; 3) introduction of constancy testing.

IEC 62985:2019 applies to – CT SCANNERS that are able to display and report CTDIVOL in accordance with IEC 60601-2-44, and – RADIATION dose index monitoring software (RDIMS) for the purpose of calculating, displaying and recording the SIZE SPECIFIC DOSE ESTIMATE (SSDE) and its associated components. Specifically, this document provides standardized methods and requirements for calculating, displaying, or recording of SSDE, SSDE(z), WATER EQUIVALENT DIAMETER (DW), and DW(z), where z represents a specific longitudinal position of the scanned object. This document provides a method of determining a reference WATER EQUIVALENT DIAMETER, DW,REF(z), using CT scans of two cylindrical water PHANTOMS and one or more anthropomorphic PHANTOM(S), which conform to the specifications defined in this document. The method of calculating the WATER EQUIVALENT DIAMETER that is implemented by the MANUFACTURER, DW,IMP(z), is tested and validated against DW,REF(z) using the TEST OBJECTS and methods defined within this document. This document also describes the methods for calculating SSDE and DW, which represent the average values of SSDE(z) and DW(z) over the RECONSTRUCTION LENGTH.

NEXT ACTION: PUBLICATION EXPECTED BY 2019-10-31
2019-07-04 IP: BT decision D163/C033 - remove link to MDD  
2017-10-09: Publication on hold due to negative assessment

IEC 60601-2-28:2010 establishes particular basic safety and essential performance requirements for X-ray tube assemblies for medical diagnosis. This second edition cancels and replaces the first edition published in 1993. This edition constitutes a technical revision. The second edition of this particular standard has been prepared to fit IEC 60601-1:2005 (the third edition of IEC 60601-1), which is referred to as the general standard.

2019-04-04-JO-: link to legislation and mandate M/295 removed following CLC/BT decision D162/C076
2018-10-31: Lack of compliance from the HAS consultant
2018-08-23 : Consultant's assessment is missing.
in-check - 2018-07-12 - Consultant's assessment is rejected at CDV stage.

This part of IEC 61223 applies to DENTAL CONE-BEAM COMPUTED TOMOGRAPHY X-RAY EQUIPMENT, hereafter also called DENTAL CBCT EQUIPMENT, that conforms to IEC 60601-2-63:2012 and IEC 60601-2-63:2012/AMD1:2017. NOTE 1 DENTAL CBCT EQUIPMENT is a subset of DENTAL EXTRA-ORAL X-RAY EQUIPMENT. NOTE 2 DENTAL EXTRA-ORAL X-RAY EQUIPMENT can provide one or more of PANORAMIC, CEPHALOMETRIC, tomosynthesis and DENTAL CBCT imaging modalities, all of which are in the scope of the IEC 60601-2-63 basic safety and performance standard. This document applies to ACCEPTANCE TESTS and CONSTANCY TESTS on DENTAL CONE-BEAM COMPUTED TOMOGRAPHY X-RAY EQUIPMENT. The aim of ACCEPTANCE TESTS is to verify compliance of the installation or MAJOR SERVICE ACTION with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning. The requirements specified in this document are minimal requirements. The MANUFACTURER can establish criteria for the tests described here that exceed the levels contained in this document. CONSTANCY TESTS are performed to ensure that the functional performance of ME EQUIPMENT meets established criteria and to enable the early recognition of changes in the properties of components of the ME EQUIPMENT, and to verify compliance with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning. This document also contains requirements for the ACCOMPANYING DOCUMENTS associated with ACCEPTANCE AND CONSTANCY TESTING of the DENTAL CBCT EQUIPMENT. This document does not apply to: - aspects of thermal, EMD (electromagnetic disturbances), mechanical and electrical safety; - aspects of mechanical, electrical and software performance, unless they are essential for performing the ACCEPTANCE TESTS and CONSTANCY TESTS, and directly affect image quality, RADIATION OUTPUT and PATIENT positioning. NOTE 3 Such aspects are generally addressed by IEC 60601-1 (all parts). Equipment in the scope of IEC 61223-3-5 is excluded from the scope of this document. DENTAL EXTRA-ORAL X-RAY EQUIPMENT can provide modalities which are in the scope of IEC 61223-3-4. In this case, the respective clauses of the IEC 61223-3-4 apply. The object of this document is to establish: - the essential parameters which describe the performance of DENTAL CBCT EQUIPMENT with regard to the image quality, RADIATION OUTPUT and PATIENT positioning; - methods of testing and whether measured quantities related to those parameters comply with the specified requirements. These methods rely on non-invasive measurements performed once the installation or a MAJOR SERVICE ACTION is completed.

This part of IEC 62464 specifies measurement procedures for the determination of many essential image quality parameters for MR EQUIPMENT. Measurement procedures as addressed in this document are suitable for - quality assessment in the ACCEPTANCE TEST, and - quality assurance in the CONSTANCY TEST. Required levels of performance for ACCEPTANCE TESTS are not provided for all tests. This document does not address - image quality assessment of MR EQUIPMENT with a static magnetic field intensity greater than 8 Tesla, if not otherwise stated, - image quality affected by MR-compatibility issues, - special diagnostic procedures such as flow imaging, perfusion, diffusion, radiotherapy and image-guided therapy applications, and - TYPE TESTS. The scope of this document is also limited to measuring image quality characteristics in images acquired on TEST DEVICES, not in PATIENT images. The measurement procedures specified in this document are directed to - MANUFACTURERS, who can demonstrate compliance by performing ACCEPTANCE and CONSTANCY TESTS as described by this document, - test houses, who can confirm performance of MR EQUIPMENT using methods described in this document, - regulatory authorities, who can reference this document, and - RESPONSIBLE ORGANISATIONS who want to perform ACCEPTANCE and CONSTANCY TESTS using methods described in this document. The essential image quality parameters and measurement methodologies defined in this document are - SIGNAL TO NOISE RATIO, - UNIFORMITY, - SLICE THICKNESS in 2-D scanning, - 2-D GEOMETRIC DISTORTION, - SPATIAL RESOLUTION, and - GHOSTING ARTEFACTS. Each of these procedures can be performed standalone or in combination with any of the other procedures. This document describes the preferred measurement procedures. It also describes alternative normative methods in Annex A. The preferred test methods may be substituted with these If necessary, other methods not described in this document can be used, provided those other test methods are documented and validated against the methods described in the document: it means an analysis is done by comparison to the original method that demonstrates a similar, or better, level of sensitivity to the same parameter of interest and a similar, or better, level of robustness against unrelated parameters. All methods will produce quantitative results. The rationale to the preferred and alternate methods, and their pitfalls, are described in Annex B. This document also presents requirements for CONSTANCY TESTS suitable for MR EQUIPMENT quality assurance programs concerning essential image quality parameters. There are no preferred CONSTANCY TEST methods, to provide flexibility in using existing automated procedures where available, but suggested examples of test methods can be found in Annex A. This document places an emphasis on consistently repeatable, automated measuring tools that facilitate trend analysis and the frequent quick testing of a small set of important parameters that are sensitive to the overall operating characteristics of the MR EQUIPMENT. NOTE None of the methods found in this document have been extensively tested at a static magnetic field intensity above 3 T. Initial tests indicate the methods function correctly when appropriate TEST DEVICE fillers are used.

This part of IEC 62563 establishes the performance CRITERIA and test frequencies for the ACCEPTANCE TESTS and CONSTANCY TESTS. The evaluation methods are defined in IEC 62563-1. The scope of this document is directed to practical tests that can be visually evaluated or measured using basic test equipment. This document applies to medical IMAGE DISPLAY SYSTEMS, which can display monochrome image information in the form of greyscale values on colour and greyscale IMAGE DISPLAY SYSTEMS. This document does not apply to information displays and to displays used solely for control of technical settings of all medical information.

No scope available

No scope available

2018-03-06: Link to MDD removed.

IEC 60336:2020 applies to FOCAL SPOTS in medical diagnostic X-RAY TUBE ASSEMBLIES for medical use, operating at X-RAY TUBE VOLTAGES up to and including 150 kV. This document describes the test methods employing digital detectors for determining: a) FOCAL SPOT dimensions in terms of NOMINAL FOCAL SPOT VALUES, ranging from 0,1 to 3,0; b) LINE SPREAD FUNCTIONS; c) one-dimensional MODULATION TRANSFER FUNCTIONS; d) FOCAL SPOT PINHOLE RADIOGRAMS, and the means for indicating compliance. In informative annexes, STAR PATTERN imaging and BLOOMING VALUE are described. IEC 60336:2020 cancels and replaces the fourth edition published in 2005. This edition constitutes a technical revision. The significant changes of this fifth edition with respect to the previous edition are detailed in Clause E.6. These changes are: a) introduction of digital detectors and discretization errors; b) fewer normative requirements; c) support for both SLIT CAMERA and PINHOLE CAMERA; d) reintroduction of distorted (skewed) FOCAL SPOT; e) keeping of STAR PATTERNS and BLOOMING VALUE as informative.

IEC 60522-1:2020 applies to X-RAY TUBE ASSEMBLIES and to FILTERING MATERIAL, in medical diagnostic applications up to a HIGH VOLTAGE of 150 kV. For HIGH VOLTAGES greater than 50 kV, this document applies to X-RAY TUBE ASSEMBLIES with tungsten or tungsten-alloy TARGETS only. IEC 60522-1:2021 defines the concept of PERMANENT FILTRATION of X-RAY TUBE ASSEMBLIES, and it defines the term FILTERING MATERIAL. Methods are given to determine the PERMANENT FILTRATION of an X-RAY TUBE ASSEMBLY and for determining the QUALITY EQUIVALENT FILTRATION of FILTERING MATERIALS. It contains requirements for statements of compliance of X-RAY TUBE ASSEMBLIES in ACCOMPANYING DOCUMENTS and for markings on X-RAY TUBE ASSEMBLIES, and for indications and statements of compliance of FILTERING MATERIAL. IEC 60522-1:2020 cancels and replaces the second edition of IEC 60522 published in 1999. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the IEC 60522:1999: The scope of the IEC 60522-1 has been changed with respect to second edition of the IEC 60522 as follows: a) As radiotherapy standards do not reference IEC 60522, radiotherapy is no longer in the scope. Consequently, the HIGH VOLTAGE is limited to 150 kV, and copper is no longer used as reference material. b) While IEC 60522:1999 covers only PERMANENT FILTRATION, IEC 60522-1 also covers quite generally “material filtering the X-RAY BEAM incident on the PATIENT”. This concerns materials like ADDED FILTERS, table-tops, a breast COMPRESSION DEVICE, and materials in the BEAM LIMITING DEVICE. For these materials the defined term FILTERING MATERIAL has been introduced. c) In order to provide technical and scientific background and rationale on the content of IEC 60522-1, IEC TR 60522-2 was introduced.

IEC 61223-3-6:2020 applies to the performance of MAMMOGRAPHIC X-RAY EQUIPMENT when used in MAMMOGRAPHIC TOMOSYNTHESIS modes of operation, with respect to image quality and dose. Excluded from the scope of this document are: - MAMMOGRAPHIC X-RAY EQUIPMENT modes of operation other than MAMMOGRAPHIC TOMOSYNTHESIS; - 2D images synthesised from the tomosynthesis images; - reconstructive TOMOGRAPHY other than MAMMOGRAPHIC TOMOSYNTHESIS; - CT SCANNERS covered by IEC 61223-3-5. IEC 61223-3-6:2020 defines a) the essential parameters which describe the acceptability criteria of MAMMOGRAPHIC TOMOSYNTHESIS modes of operation of MAMMOGRAPHIC X-RAY EQUIPMENT with regard to image quality and dose, b) the methods of testing whether measured quantities related to those parameters comply with specified tolerances, and c) CONSTANCY TEST frequency when required. This document is intended to be applied along with the acceptability criteria included in IEC 61223-3-2 or equivalent protocol for 2D mammography which are also relevant for MAMMOGRAPHIC TOMOSYNTHESIS modes of operation. These methods mainly rely on non-invasive measurements that use appropriate test equipment and are performed during or after the installation. Signed statements covering steps in the installation procedure can be used as part of the ACCEPTANCE TEST. Tests required by a higher level of compliance take precedence over similar tests with a lower level of compliance. When the results of the ACCEPTANCE TEST are in compliance with the expected values, the BASELINE VALUES for the subsequent CONSTANCY TESTS are established.

2020-01-08 CV: BT decision (D164/C119) to proceed to publication without link to legislation
2019-11-07 mah: consultant assessment missing: blocked.
2019-11-12 - JO: BT document to remove link to the MDD under review

2020-03-17-JO- BT decision BT164/DG11529/DV to remove the link to the MDD (93/42/EEC)
Publication on hold due to negative assessment

IEC 63077:2019 describes and defines the PROCESS of REFURBISHMENT of USED MEDICAL IMAGING EQUIPMENT and applies to the restoring of USED MEDICAL IMAGING EQUIPMENT to a condition of safety and performance comparable to that of new MEDICAL IMAGING EQUIPMENT i.e. MEDICAL IMAGING EQUIPMENT that was not in use. This restoration includes actions such as REPAIR, REWORK, software/hardware updates, and the replacement of worn parts with original parts. This document enumerates the actions, that are performed, and the manner consistent, with relevant specifications and service procedures required to ensure that the REFURBISHMENT of MEDICAL IMAGING EQUIPMENT is done without changing the finished MEDICAL IMAGING EQUIPMENT’s performance, safety specifications, or INTENDED USE according to its original or applicable valid registration. The MEDICAL IMAGING EQUIPMENT and systems covered by this document include: – X-RAY EQUIPMENT; – X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES; – X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY; – MAGNETIC RESONANCE EQUIPMENT; – ULTRASONIC DIAGNOSTIC EQUIPMENT; – GAMMA CAMERAS; – PLANAR WHOLEBODY IMAGING EQUIPMENT; – equipment for SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY (SPECT); – SPECT/CT hybrid systems, combining a GAMMA CAMERA with X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (CT); – POSITRON EMISSION TOMOGRAPHS (PET); – PET/CT hybrid systems combining a POSITRON EMISSION TOMOGRAPH with X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (CT); – PET/MRI hybrid systems combining a POSITRON EMISSION TOMOGRAPH with MAGNETIC RESONANCE EQUIPMENT: and – other combinations of the MEDICAL IMAGING EQUIPMENT or systems listed above. This document does not apply to endoscopic equipment, funduscopic equipment, radiation therapy equipment, nor associated systems. IEC 63077:2019 includes the following significant technical changes with respect to IEC PAS 63077:2016: a) the scope was delineated more clearly; b) an informative cross reference list of IEC 63077 vs ISO 13485 (Annex A) was added; c) smaller corrections were performed.

IEC 60601-2-44:2009 applies to the basic safety and essential performance of CT scanners. The scope of IEC 60601-2-44:2009 is limited to CT scanners intended to be used for both head and body characterised by an enclosure of the X-ray source(s) and imaging detector(s) in a common protective cover in the shape of a toroid. It includes safety requirements for the X-ray generators used in CT scanners, including those where high-voltage generators are integrated with an X-ray tube assembly. This third edition cancels and replaces the second edition published in 2001 and its Amendment 1 (2002). This edition constitutes a technical revision primarily related to radiation protection and control.

IEC 62563-1:2009 describes the evaluation methods for testing medical image display systems. It is directed to practical tests that can be visually evaluated or measured using basic test equipment. More advanced or more quantitative measurements can be performed on these devices, but these are beyond the scope of this document. IEC 62563-1:2009 applies to medical image display systems, which can display monochrome image information in the form of greyscale values on colour and greyscale image display systems (e.g. cathode ray tube (CRT) monitors, flat panel displays, projection system). This standard applies to medical image display systems used for diagnostic (interpretation of medical images toward rendering clinical diagnosis) or viewing (viewing medical images for medical purposes other than for providing a medical interpretation) purposes and therefore having specific requirements in terms of image quality. Head mounted image display systems and image display systems used for confirming positioning and for operation of the system are not covered by this standard.

2013-10-02 - BT146_DG9211 extended DOW to 2018-12-31 2013-05-02 - Publication editing allocated to aclausse@cencenelec.eu

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MR EQUIPMENT and MR SYSTEMS, hereafter referred to also as ME EQUIPMENT. This standard does not cover the application of MR EQUIPMENT beyond the INTENDED USE. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

IEC 60601-2-63:2012 applies to the basic safety and essential performance of dental extra-oral X-ray equipment, hereafter also called ME equipment. The scope includes ME systems containing such ME equipment. This particular standard has been prepared to provide, based on IEC 60601-1:2005 and its collaterals, a complete set of basic safety and essential performance requirements for dental extra-oral x-ray equipment. While the previously existing standards for such equipment were dedicated to components and subsystems, this particular standard addresses the system level of dental extra-oral x-ray equipment. Components and their functions are addressed as far as necessary. The scope of this standard is restricted to X-ray equipment where: - the x-ray tube assembly contains the high-voltage transformer assembly; and - the geometrical relations between the X-ray source, the anatomical object being imaged in the patient, and the X-ray image receptor, are preset in the design and cannot be arbitrarily altered by the operator during intended use.

NWI created for possible future // procedure

IEC 62220-1-1:2015 specifies the method for the determination of the DETECTIVE QUANTUM EFFICIENCY (DQE) of DIGITAL X-RAY IMAGING DEVICES as a function of AIR KERMA and of SPATIAL FREQUENCY for the working conditions in the range of the medical application as specified by the MANUFACTURER. The intended users of this part of IEC 62220 are manufacturers and well equipped test laboratories. This first edition of IEC 62220-1-1 cancels and replaces IEC 62220-1:2003. It constitutes a technical revision of IEC 62220-1:2003 and assures a better alignment with the other parts of the IEC 62220 series. The main changes are as follows: - necessary modifications have been applied as a consequence of taking into account IEC 61267:2005. This influences HVL values and SNRin2; - the method for the determination of LAG EFFECTS now considers lag and ghosting compensation; - as part of the MTF determination, the method of obtaining the final averaged MTF has been restricted (only averaging of the ESF is allowed); - a description of (optionally) obtaining the diagonal (45°) MTF and NPS has been added.

IEC 62570:2014 applies to the practice of marking of items that might be used in the magnetic resonance (MR) environment. The purpose of this practice is to mark items that might be brought into the MR environment and to recommend information that should be included in the marking. The standard specifies the permanent marking of items, which are used in an MR environment, by means of terms and icons. MR image artifacts are not considered to be a performance issue and so are not addressed in this international standard practice. IEC 62570 is integrating the unmodified text of ASTM F2503-13. It has been developed by subcommittee 62B: Diagnostic imaging equipment, of IEC technical committee 62: Medical equipment in medical practice, in collaboration with ASTM.

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MR EQUIPMENT and MR SYSTEMS, hereafter referred to also as ME EQUIPMENT. This standard does not cover the application of MR EQUIPMENT beyond the INTENDED USE. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

IEC 60627:2013 is applicable to anti-scatter grids used in medical diagnostic X-ray imaging equipment. Anti-Scatter Grids are used to reduce the incidence of scattered radiation, produced particularly in the body of the patient, upon the image reception area and thus to improve the contrast of the X-ray pattern. This International Standard specifies the definitions, determination and indication of characteristics of anti-scatter grids. In this standard only linear grids are considered. Since at present only focused grids are used in mammography, this standard is restricted to focused grids where mammographic anti-scatter grids are concerned. This standard is not intended to be applied for acceptance tests. This standard does not cover the homogeneity of performance over the area of a grid. This standard is intended to be applied for the determination of the characteristics of anti-scatter grids under test conditions. These conditions are not usually available at the site of the responsible organization. This third edition cancels and replaces the second edition published in 2001, and constitutes a technical revision. In this revision calcium tungstate phosphor fluorescent screens, which are no longer available, have been replaced by gadolinium oxysulphide (GOS) fluorescent screens. Further, a new quality parameter is introduced: the Image Improvement Factor or Q-factor, which better describes the properties of the anti-scatter grid, especially for digital detector applications. Further differences between this third edition and the previous second edition are: - new instrumentation is prescribed for measurements of the transmission of primary radiation, the transmission of scattered radiation and the transmission of total radiation, because fluorescent screens made of calcium tungstate phosphors are outdated and are no longer available; - the definition of the phantom used for measurements of the transmission of primary radiation, the transmission of scattered radiation and the transmission of total radiation is modified and references to IEC 61267 are omitted; - and the radiation conditions used for the measurements have been adapted and are now the RQR and RQR-M conditions specified in IEC 61267:2005.

IEC 61910-1:2014 applies to radiation dose structured reports produced by X ray equipment that falls within the scope of IEC 60601-2-43:2010 or IEC 60601-2-54:2009. This document does not impose specific requirements on the accuracy of the reported or displayed data. Existing standards or regulations can have applicable requirements for accuracy and precision. This standard provides specific units and quantities and prescribes data storage formats. This document does not present any requirements on the form of display of dose information to operators or other individuals. The objective of this International Standard is to specify the minimum dataset to be used for reporting dosimetric and related information associated with the production of projection radiological images. This first edition cancels and replaces IEC/PAS 61910-1, published in 2007. It constitutes a technical revision which includes the following significant technical changes with respect to IEC/PAS 61910-1:2007: - the previously defined three conformance levels have been restructured to two; - the mapping between DICOM and IEC terms is explicitly described in an annex and is decoupled from the conformance level content requirements; - and a general update to the revised contents of the DICOM RDSR definition has occurred.

IEC 61331-2:2014 applies to translucent protective plates used for radiation protection in X-ray diagnosis and in X-ray therapy. It also applies to translucent protective plates used for protection against gamma radiation in nuclear medicine and brachytherapy with automatically-controlled afterloading equipment. It does not cover other translucent radiation protection materials, e.g. leaded glasses or goggles for protection of the operator's eyes (eye spectacles); leaded face shields, which cover the entire face of the operator; patient eye protection; and thyroid/neck protective devices. This Part 2 deals with the requirements on: - geometrical accuracy; - optical quality of the material; - spectral transmittance; - radiation attenuation properties; - marking; and - statement of compliance with this standard. This second edition cancels and replaces the first edition of IEC 61331-2, published in 1994. It constitutes a technical revision. This second edition has been adapted to apply to the present technology. The essential changes and extensions are: - extension of scope to cover all kinds of translucent protective plates and all kinds of radiation qualities and gamma radiation; - removal of definition and requirements for translucent protective plates for visual imaging; - changes of requirements concerning geometrical accuracy and optical quality; - changes of requirements concerning determination of lead equivalent and minimal thickness; and - changes of requirements concerning information and marking.

IEC 61331-3:2014 applies to protective devices such as protective clothing and eyewear for the protection of persons against X radiation up to 150 kV, during radiological examinations and interventional procedures. This standard deals with general requirements on the accompanying documents, on design and on materials used and with sizing, particular design features, minimum attenuation properties of materials, marking and standardized forms of statements of compliance with this standard. It covers protective clothing mainly for the protection of the operator, such as: - protective aprons; - thyroid collars; - protective gloves; - protective mittens; and - protective eyewear. It also covers protective devices for the protection of the patient, such as: - protective gonad aprons; - scrotum shields; - ovary shields; - shadow shields; and - protective aprons for dental use. The latter group of protective devices is intended to be used during radiological examinations to minimize the effects of irradiation on the reproductive organs particularly with regard to genetic damage. This second edition cancels and replaces the first edition of IEC 61331-3, published in 1998. It constitutes a technical revision. This second edition has been adapted to apply to the present technology. It includes a requirement to use a better method for the determination of attenuation properties over a broader and more clinically relevant range of radiation qualities appropriate to the use of the devices. It also covers three additional protective devices, thyroid collars, protective eyewear and protective aprons for dental use.

IEC 61331:2014 applies to materials in sheet form used for the manufacturing of protective devices against X-radiation of radiation qualities generated with X-ray tube voltages up to 400 kV and gamma radiation emitted by radionuclides with photon energies up to 1,3 MeV. This Part 1 is not intended to be applied to protective devices when these are to be checked for the presence of their attenuation properties before and after periods of use. This Part 1 specifies the methods of determining and indicating the attenuation properties of the materials. The attenuation properties are given in terms of: - attenuation ratio; - build-up factor; and - attenuation equivalent together with, as appropriate, an indication of homogeneity and mass per unit area. Ways of stating values of attenuation properties in compliance with this part of the International Standard are included. Excluded from the scope of this International Standard are the methods for periodical checks of protective devices, particularly of protective clothing, the methods of determining attenuation by layers in the radiation beam, and the methods of determining attenuation for purposes of protection against ionizing radiation provided by walls and other parts of an installation. This second edition cancels and replaces the first edition of IEC 61331-1, published in 1994. It constitutes a technical revision. This second edition has been adapted to apply to the present technology. In particular, this second edition is consistently applicable to lead- and non-lead-containing materials. The essential changes and extensions are: - the extension of the scope to cover photon-emitting radionuclides; - improved methods to determine the attenuation ratio; - the addition of the so-called inverse broad beam condition; - the addition of a method to calculate the attenuation ratio of photon-emitting radionuclides; - the definition of new standard X- and gamma radiation qualities used for testing; - the addition of the so-called lead equivalent class; and - tables of attenuation ratios, build-up factors and first half-value layers for the standard radiation qualities filtered with different thicknesses of lead.

IEC 60601-2-65:2012 applies to the basic safety and essential performance of dental intra-oral X-ray equipment and its main components. The scope of this standard is restricted to X-ray equipment where the X-ray tube assembly contains the high-voltage transformer assembly. Dental extra-oral X-ray equipment is excluded from the scope of this standard. This particular standard has been prepared to provide, based on IEC 60601-1:2005 and its collaterals, a complete set of basic safety and essential performance requirements for dental intra-oral X-ray equipment. While the previously existing standards for such equipment were dedicated to components and subsystems, this particular standard addresses the system level of dental intra-oral X-ray equipment. Components and their functions are addressed as far as necessary.

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of CT SCANNERS, hereafter also referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. NOTE 1 See also 4.2 of the general standard. The scope of this document is limited to CT SCANNERS intended to be used for both head and body characterised by an ENCLOSURE of the X-ray source(s) and imaging detector(s) in a common protective cover in the shape of a toroid. It includes safety requirements for the XRAY GENERATORS used in CT SCANNERS, including those where HIGH-VOLTAGE GENERATORS are integrated with an X-RAY TUBE ASSEMBLY. NOTE 2 Requirements for X-RAY GENERATORS and for ASSOCIATED EQUIPMENT, which were previously specified in IEC 60601-2-7 and IEC 60601-2-32, have been included in either IEC 60601-1:2005 (Ed3) or this edition of IEC 60601-2-44. Therefore IEC 60601-2-7 and IEC 60601-2-32 are not part of the 3rd edition scheme for COMPUTED TOMOGRAPHY.

IEC 60601-2-33:2010 establishes particular basic safety and essential performance requirements for magnetic resonance equipment to provide protection for the patient and the magnetic resonance worker. This third edition cancels and replaces the second edition published in 2002, its Amendment 1 (2005) and Amendment 2 (2007) and constitutes a technical revision. This third edition of IEC 60601-2-33 is based on the second amendment to Edition 2. It has also been adapted to the third edition of IEC 60601-1 (2005), with technical modifications being introduced where appropriate.

IEC 60601-2-43:2010 establishes particular basic safety and essential performance requirements for the design and manufacture of X ray equipment for radioscopically guided interventional procedures. It specifies information which is to be provided with such interventional X-ray equipment for the assistance of the responsible organization and operator in managing the radiation risk and equipment failure risk arising from these procedures which could affect patients or staff. This second edition cancels and replaces the first edition published in 2000. This particular standard has been revised to provide a complete set of safety requirements for X-ray equipment for radioscopically guided interventional procedures, based on the third edition of IEC 60601-1 and relevant collaterals. The present edition is extended to become a system standard for X-ray equipment designed for the use during interventional procedures using X-ray imaging, whether of prolonged or normal duration.

IEC 60613:2010 applies to X-ray tube assemblies either with a rotating anode X-ray tube or a stationary anode X-ray tube, intended for use in medical diagnosis. For an X-ray tube head, its X-ray tube assembly aspects are also within the scope. IEC 60613:2010 covers performance-related definitions and conditions of electrical and loading characteristics of X-ray tube assemblies in relation to their behaviour during and after energization and, where appropriate, methods of presentation and measurement of these characteristics. This International Standard is therefore relevant for the manufacturer and the responsible organization. This third edition cancels and replaces the second edition of IEC 60613, published in 1989. It constitutes a technical revision. This third edition has been adapted to apply to the present technology.

IEC 62563-1:2009 describes the evaluation methods for testing medical image display systems. It is directed to practical tests that can be visually evaluated or measured using basic test equipment. More advanced or more quantitative measurements can be performed on these devices, but these are beyond the scope of this document. IEC 62563-1:2009 applies to medical image display systems, which can display monochrome image information in the form of greyscale values on colour and greyscale image display systems (e.g. cathode ray tube (CRT) monitors, flat panel displays, projection system). This standard applies to medical image display systems used for diagnostic (interpretation of medical images toward rendering clinical diagnosis) or viewing (viewing medical images for medical purposes other than for providing a medical interpretation) purposes and therefore having specific requirements in terms of image quality. Head mounted image display systems and image display systems used for confirming positioning and for operation of the system are not covered by this standard.

IEC 60601-2-54:2009 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems intended to be used for projection radiography and radioscopy. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of ME equipment for radiography and radioscopy. Requirements for additional provisions for ME equipment for interventional applications are covered by IEC 60601-2-43. IEC 60601-2-54:2009 has been developed for use with the third edition of IEC 60601-1 (2005) and its collateral standards. IEC 60601-2-54:2009 is about type testing of X-ray systems. For the type test of a given product only one particular standard applies. Thus, IEC 60601-2-28 cannot be used in the type test according to IEC 60601-2-54:2009. The system aspects of the X-ray source integrated into X-ray systems are covered by IEC 60601-2-54:2009. IEC 60601-2-32 and IEC 60601-2-7, which had been written for use with the second edition of IEC 60601-1 (1988), cannot be used with the third edition of IEC 60601-1 (2005) and IEC 60601-2-54.