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 info...
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    • Standard
      90 pages
      English and French language

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 de...
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    • Standard
      37 pages
      English and French language

IEC TR 60522-2:2020 provides guidance on quality equivalent filtration and permanent filtration with regards to the requirements of IEC 60522-1 and its modifications versus IEC 60522:1999.

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    • Technical report
      35 pages
      English language

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 ...
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    • Standard
      108 pages
      English and French language

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 perfo...view more

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    • Standard
      33 pages
      English and French language

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 t...
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    • Standard
      126 pages
      English and French language

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 represen...
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    • Standard
      42 pages
      English and French language

IEC 62464-1:2018 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 gre...
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    • Standard
      178 pages
      English and French language

ISO/TS 10974:2018 is applicable to implantable parts of active implantable medical devices (AIMDs) intended to be used in patients who undergo a magnetic resonance scan in 1,5 T, cylindrical (circular or elliptical cross-section) bore, whole body MR scanners operating at approximately 64 MHz with whole body coil excitation.
NOTE 1 Requirements for non-implantable parts are outside the scope of this document.
The tests that are specified in this document are type tests that characterize interac...
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    • Technical specification
      214 pages
      English language

IEC 60601-2-28:2017 is also available as IEC 60601-2-28:2017 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
IEC 60601-2-28:2017 applies to the basic safety and essential performance of X-ray tube assemblies and to components thereof, intended for medical diagnosis and imaging. Where the general standard IEC 60601-1 and the collateral standard IEC 60601-1-3 refer to me equipment, this is inte...
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    • Standard
      48 pages
      English and French language

Specifies the requirements for testing items of equipment intended for use on railway vehicles which are subsequently subjected to vibrations and chock owing to the nature of railway operational environment.

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    • Standard
      9 pages
      English and French language

Details the particular specification for light polyvinyl chloride sheathed cables of rated voltage of 300/500 V.[
]This consolidated version consists of the second edition (1992) and its amendment 1 (1997). Therefore, no need to order amendment in addition to this publication.

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    • Standard
      8 pages
      English and French language

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...view more

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    • Standard
      74 pages
      English and French language

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...view more

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    • Standard
      64 pages
      English and French language

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 cove...view more

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    • Standard
      56 pages
      English and French language

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 cove...view more

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    • Standard
      21 pages
      English and French language

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 i...view more

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    • Standard
      50 pages
      English and French language

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...view more

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    • Standard
      34 pages
      English and French language

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 ...view more

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    • Standard
      69 pages
      English and French language

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 comp...view more

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    • Standard
      92 pages
      English and French language

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 ...view more

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    • Standard
      87 pages
      English and French language

IEC 60601-2-45:2011 applies to the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices. IEC 60601-2-45:2011 addresses the system level of mammographic X-ray equipment, which consists of a combination of an X-ray generator, associated equipment and accessories. Components functions are addressed as far as necessary. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safe...view more

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    • Standard
      103 pages
      English and French language

IEC 62464-2:2010 specifies the description of pulse sequences of magnetic resonance imaging. The classification in this standard is suitable for:
- tender texts;
- image annotation;
- protocol definition;
- technical publications.
IEC 62464-2:2010 does not apply to magnetic resonance spectroscopy. The classification does not focus on image contrast (T1, T2, proton density), as this is defined by pulse sequence parameters (e.g. repetition time, echo time) and is not a property of the pulse s...
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    • Standard
      26 pages
      English and French language

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 c...view more

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    • Standard
      108 pages
      English and French language

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 ...view more

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    • Standard
      219 pages
      English and French language

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 measure...view more

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    • Standard
      41 pages
      English and French language

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 di...view more

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    • Standard
      114 pages
      English and French language

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...view more

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    • Standard
      141 pages
      English and French language

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 thi...view more

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    • Standard
      90 pages
      English and French language

IEC 62494-1:2008 specifies definitions and requirements for the exposure index of images acquired with digital X-ray imaging systems. IEC 62494-1:2008 is applicable to digital X-ray imaging systems used in general radiography for producing projection X-ray images for general applications, such as, but not exclusively:
- computed radiography (CR) systems based on stimulable phosphors;
- flat-panel detector based systems;
- charge-coupled device (CCD) based systems.
Image intensifier based sys...
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    • Standard
      40 pages
      English and French language

IEC 62220-1-3:2008 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 Part 1-3 is restricted to digital X-ray imaging devices that are used for dynamic imaging such as, but no...view more

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    • Standard
      68 pages
      English and French language

This collateral standard applies to X-ray equipment and to subassemblies of such equipment, where radiological images of a human patient are used for diagnosis, planning or guidance of medical procedures. The object of this collateral standard is to establish general requirements for protection against X-radiation in X-ray equipment, in order that the irradiation of the human patient, the operator, staff and members of the public can be kept as low as reasonably achievable, without jeopardizing ...view more

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    • Standard
      99 pages
      English and French language

Applies to the basic safety and essential performance of ultrasonic diagnostic equipment. The approach and philosophy used in drafting this particular standard for safety of ultrasonic diagnostic equipment are consistent with those in standards of the IEC 60601 2 xx series that apply to other diagnostic modalities, such as X-ray equipment and magnetic resonance systems. In each case, the safety standard is intended to require increasing sophistication of output display indicators and/or controls...view more

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    • Standard
      82 pages
      English and French language

This part of IEC 61223 applies to the effectiveness of mammographic X-ray equipment, with respect to image quality and dose, in combination with aspects of equipment safety. This standard applies to mammographic X-ray equipment and mammographic stereotactic devices. The tests described in this standard require the quality and performance of the X-ray image receptors to be assured prior to the acceptance testing when they are not an integral part of the mammographic X-ray equipment. This includes...view more

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    • Standard
      125 pages
      English and French language

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 Part 1-2 is restricted to digital X-ray imaging devices that are used for mammographic imaging such as but not exclusively, ...view more

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    • Standard
      59 pages
      English and French language