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.

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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.

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IEC 60601-2-43:2022 is available as IEC 60601-2-43:2022 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-43:2022 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.
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 document.
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.
IEC 60601-2-54 applies only with regards to the cited subclauses; non-cited subclauses of IEC 60601-2-54 do not apply.
IEC 60601-2-43:2022 cancels and replaces the second edition published in 2010, Amendment 1:2017 and Amendment 2:2019. This edition constitutes a technical revision.
This edition includes editorial and technical changes to reflect the IEC 60601-1:2005/AMD2:2020 and IEC 60601-2-54:2022. 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 as in IEC 60601-2-54:2022;
b) several terms and definitions that are moved from IEC TR 60788:2004 to 201.3 of IEC 60601-2-54:2022 are also referenced from IEC 60601-2-54:2022.
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 former subclause 201.11.101 “Protection against excessive temperature of X-RAY TUBE ASSEMBLIES” is removed since covered by IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 and IEC 60601-2-28:2017, and the former subclause 201.11.102 is renumbered as 201.11.101, as in IEC 60601-2-54:2022;
e) to adopt changes in subclause 7.8.1 “Colours of indicator lights” in IEC 60601 1:2005/AMD2:2020, clarification of requirements is provided in 201.7.8.1 to avoid conflicts with requirements of indicator lights stipulated for X-RAY EQUIPMENT, as in IEC 60601-2-54:2022;
f) explanation of the term ESSENTIAL PERFORMANCE is provided in Annex AA to emphasize the performance of the clinical function under NORMAL CONDITIONS and SINGLE FAULT CONDITIONS.

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ISO 14096-1:2005 specifies procedures for the evaluation of basic performance parameters of the radiographic film digitisation process such as spatial resolution and spatial linearity, density range, density contrast sensitivity and characteristic transfer curve. They can be integrated into the system software and together with a standard reference film used for quality control of the digitisation process. This reference film provides a series of test targets for performance evaluation. The test targets are suitable for evaluating a digitisation system with a spatial resolution down to 25 micrometres, a density contrast sensitivity down to 0,02 optical density, a density range of 0,5 to 4,5 and a film size capacity of (350 x 430) mm2. This standard does not address signal processing and display of the digitised data.

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ISO 14096-2:2005 specifies three film-digitisation quality classes for the requirements of non-destructive testing. The selected class depends on the radiation energy, penetrated material thickness and the quality level of the original radiographic film. ISO 14096-2:2005 does not address signal processing, display and storage of the digitised data.

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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

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ISO 14096-1:2005 specifies procedures for the evaluation of basic performance parameters of the radiographic film digitisation process such as spatial resolution and spatial linearity, density range, density contrast sensitivity and characteristic transfer curve. They can be integrated into the system software and together with a standard reference film used for quality control of the digitisation process. This reference film provides a series of test targets for performance evaluation. The test targets are suitable for evaluating a digitisation system with a spatial resolution down to 25 micrometres, a density contrast sensitivity down to 0,02 optical density, a density range of 0,5 to 4,5 and a film size capacity of (350 x 430) mm2. This standard does not address signal processing and display of the digitised data.

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ISO 14096-2:2005 specifies three film-digitisation quality classes for the requirements of non-destructive testing. The selected class depends on the radiation energy, penetrated material thickness and the quality level of the original radiographic film. ISO 14096-2:2005 does not address signal processing, display and storage of the digitised data.

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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

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This document specifies a procedure for the control of film processing systems.

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This document specifies a procedure for the control of film processing systems.

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This document specifies a procedure for the control of film processing systems.

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This International Standard establishes a system for the classification of intra-oral radiographic film by the speed of the film/process system and by the size of the film. It specifies the sensitometric characteristics of the film/process systems, the physical characteristics of the film and packets, and it describes packaging and labelling requirements. This International Standard is applicable to intra-oral dental radiographic film for manual or automatic processing. It does not apply to films intended to be exposed with fluorescent intensifying screens, or films intended to be viewed primarily by reflected light.

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ISO 3665:2011 establishes a system for the classification of intra-oral radiographic film by the speed of the film/process system and by the size of the film. It specifies the sensitometric characteristics of the film/process systems, the physical characteristics of the film and packets, and it describes packaging and labelling requirements.
ISO 3665:2011 is applicable to intra-oral dental radiographic film for manual or automatic processing. It does not apply to films intended to be exposed with fluorescent intensifying screens, or films intended to be viewed primarily by reflected light.

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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.

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ISO 3665:2011 establishes a system for the classification of intra-oral radiographic film by the speed of the film/process system and by the size of the film. It specifies the sensitometric characteristics of the film/process systems, the physical characteristics of the film and packets, and it describes packaging and labelling requirements.
ISO 3665:2011 is applicable to intra-oral dental radiographic film for manual or automatic processing. It does not apply to films intended to be exposed with fluorescent intensifying screens, or films intended to be viewed primarily by reflected light.

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The purpose of ISO 11699-1:2008 is to establish the performance of film systems.
ISO 11699-1:2008 is applicable for the classification of film systems in combination with specified lead screens for industrial radiography (non-destructive testing). ISO 11699-1:2008 is intended to ensure that the image quality of radiographs – as far as this is influenced by the film system – is in conformity with the requirements of International Standards such as ISO 5579, ISO 17636 and EN 12681.
ISO 11699-1:2008 does not apply to the classification of films used with fluorescent intensifying screens. The measurement of film systems in ISO 11699-1:2008 is restricted to a selected radiation quality to simplify the procedure. The properties of films will change with radiation energy, but not the ranking of film system quality.
Additional methods for evaluating the photographic process are described in ISO 11699-2, by which the performance of film systems can be controlled under the conditions given in industry.

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This document describes a procedure for the control of film processing systems.

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The purpose of ISO 11699-1:2008 is to establish the performance of film systems.
ISO 11699-1:2008 is applicable for the classification of film systems in combination with specified lead screens for industrial radiography (non-destructive testing). ISO 11699-1:2008 is intended to ensure that the image quality of radiographs – as far as this is influenced by the film system – is in conformity with the requirements of International Standards such as ISO 5579, ISO 17636 and EN 12681.
ISO 11699-1:2008 does not apply to the classification of films used with fluorescent intensifying screens. The measurement of film systems in ISO 11699-1:2008 is restricted to a selected radiation quality to simplify the procedure. The properties of films will change with radiation energy, but not the ranking of film system quality.
Additional methods for evaluating the photographic process are described in ISO 11699-2, by which the performance of film systems can be controlled under the conditions given in industry.

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ISO 3665:2011 establishes a system for the classification of intra-oral radiographic film by the speed of the film/process system and by the size of the film. It specifies the sensitometric characteristics of the film/process systems, the physical characteristics of the film and packets, and it describes packaging and labelling requirements. ISO 3665:2011 is applicable to intra-oral dental radiographic film for manual or automatic processing. It does not apply to films intended to be exposed with fluorescent intensifying screens, or films intended to be viewed primarily by reflected light.

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Specifies methods for determination of the sensitometric curve shape, average gradient and speed of a single sample of a screen/film/filmholder/processing system in mammograhpy.

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This International Standard specifies methods for determining sensitometric curve shape, ISO speed, ISO average gradient and ISO gradients G2 and G4 for industrial radiographic systems consisting of film and film processing when exposed directly to X-rays and ã-rays. The measurement of characteristics of film systems used in industrial radiography with fluorescent intensifying screens is not specified in this International Standard. Units of measured energy are given for information in annex A.

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This part of ISO 9236 specifies methods for the determination of the sensitometric curve shape, average gradient and speed of a single sample of a screen/film/filmholder/processing system for medical radiography. It is not applicable to special radiographic applications such as mammography, dental radiography and directexposing medical radiographic systems (see for example ISO 5799 [3]). The filmholder can be any means that ensures close screen/film contact and prevents the film from being exposed to ambient light. In particular, the filmholder can be a light-tight vacuum bag, as often used in the laboratory, or a radiographic cassette as used in medical radiography.

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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.

  • Standard
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The purpose of ISO 11699-1:2008 is to establish the performance of film systems. ISO 11699-1:2008 is applicable for the classification of film systems in combination with specified lead screens for industrial radiography (non-destructive testing). ISO 11699-1:2008 is intended to ensure that the image quality of radiographs – as far as this is influenced by the film system – is in conformity with the requirements of International Standards such as ISO 5579, ISO 17636 and EN 12681. ISO 11699-1:2008 does not apply to the classification of films used with fluorescent intensifying screens. The measurement of film systems in ISO 11699-1:2008 is restricted to a selected radiation quality to simplify the procedure. The properties of films will change with radiation energy, but not the ranking of film system quality. Additional methods for evaluating the photographic process are described in ISO 11699-2, by which the performance of film systems can be controlled under the conditions given in industry.

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ISO 14096-1:2005 specifies procedures for the evaluation of basic performance parameters of the radiographic film digitisation process such as spatial resolution and spatial linearity, density range, density contrast sensitivity and characteristic transfer curve. They can be integrated into the system software and together with a standard reference film used for quality control of the digitisation process. This reference film provides a series of test targets for performance evaluation. The test targets are suitable for evaluating a digitisation system with a spatial resolution down to 25 micrometres, a density contrast sensitivity down to 0,02 optical density, a density range of 0,5 to 4,5 and a film size capacity of (350 x 430) mm2. This standard does not address signal processing and display of the digitised data.

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ISO 14096-2:2005 specifies three film-digitisation quality classes for the requirements of non-destructive testing. The selected class depends on the radiation energy, penetrated material thickness and the quality level of the original radiographic film. ISO 14096-2:2005 does not address signal processing, display and storage of the digitised data.

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This International Standard specifies the nominal sizes, aim dimensions with tolerances, weights, and certain tests
for medical radiographic cassettes, screens, and films. It includes medical hard-copy imaging films in the form of
sheets, such as laser films and video.
This International Standard also includes information regarding the appropriate marking of these products, and
special attention is given to cassettes/screens/films used for mammography.
This International Standard does not include films in roll format (see informative annex A).

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This International Standard specifies the nominal sizes, aim dimensions with tolerances, weights, and certain tests
for medical radiographic cassettes, screens, and films. It includes medical hard-copy imaging films in the form of
sheets, such as laser films and video.
This International Standard also includes information regarding the appropriate marking of these products, and
special attention is given to cassettes/screens/films used for mammography.
This International Standard does not include films in roll format (see informative annex A).

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ISO 9236-1:2004 specifies methods for the determination of the sensitometric curve shape, average gradient and speed of a single sample of a screen/film/filmholder/processing system for medical radiography. It is not applicable to special radiographic applications such as mammography, dental radiography and direct-exposing medical radiographic systems (see for example ISO 5799). The filmholder can be any means that ensures close screen/film contact and prevents the film from being exposed to ambient light. In particular, the filmholder can be a light-tight vacuum bag, as often used in the laboratory, or a radiographic cassette as used in medical radiography.

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ISO 7004:2002 specifies methods for determining sensitometric curve shape, ISO speed, ISO average gradient and ISO gradients G2 and G4 for industrial radiographic systems consisting of film and film processing when exposed directly to X-rays and gamma-rays. The measurement of characteristics of film systems used in industrial radiography with fluorescent intensifying screens is not specified in this International Standard.

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  • Standard
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This International Standard specifies the nominal sizes, aim dimensions with tolerances, weights, and certain tests for medical radiographic cassettes, screens, and films. It includes medical hard-copy imaging films in the form of sheets, such as laser films and video. This International Standard also includes information regarding the appropriate marking of these products, and special attention is given to cassettes/screens/films used for mammography. This International Standard does not include films in roll format (see informative annex A).

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This International Standard specifies the preferred and recognized sizes and cutting dimensions of industrial radiographic roll and sheet films and metal intensifying screens. It also specifies package markings. The shaping of the corners of screens is not specified.

  • Standard
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This part of ISO 9236 specifies methods for determination of the sensitometric curve shape, average gradient and speed of a single sample of a screen/film/filmholder/processing system in mammography. The filmholder may be any means which ensures close screen/film contact and prevents the film from being exposed to ambient light. In particular, the filmholder may be a light-tight vacuum bag, as often used in the laboratory, or a radiographic cassette as used in mammography. NOTE — Hereafter, screen/film/filmholder combinations will be referred to as "combinations", and will be referred to as "systems" when the processing is included.

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Specifies measuring methods so that the film/process system can be obtained reproducibly and can also be compared with those of other systems. Describes sensitometric procedures for films exposed directly to X-rays. This second edition cancels and replaces the first edition (1981).

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  • Standard
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  • Standard
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This European Standard specifies procedures for the evaluation of basic performance parameters of the radiographic film digitisation process such as spatial resolution and spatial linearity, density range, density contrast sensitivity and characteristic transfer curve. They can be integrated into the system software and together with a standard reference film (as described in clause 5) used for quality control of the digitisation process. This reference film provides a series of test targets for performance evaluation. The test targets are suitable for evaluating a digitisation system with a spatial resolution down to 25 µm, a density contrast sensitivity down to 0,02 optical density, a density range of 0,5 to 4,5 and a film size capacity of (350 x 430) mm2. This standard does not address signal processing and display of the digitised data.

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This European Standard specifies three film-digitisation quality classes for the requirements of non-destructive testing. The selected class depends on the radiation energy, penetrated material thickness and the quality level of the original radiographic film. This European Standard does not address signal processing, display and storage of the digitised data.

  • Standard
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This European Standard specifies procedures for the evaluation of basic performance parameters of the radiographic film digitisation process such as spatial resolution and spatial linearity, density range, density contrast sensitivity and characteristic transfer curve. They can be integrated into the system software and together with a standard reference film (as described in clause 5) used for quality control of the digitisation process. This reference film provides a series of test targets for performance evaluation. The test targets are suitable for evaluating a digitisation system with a spatial resolution down to 25 µm, a density contrast sensitivity down to 0,02 optical density, a density range of 0,5 to 4,5 and a film size capacity of (350 x 430) mm². This standard does not address signal processing and display of the digitised data.

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This European Standard specifies three film-digitisation quality classes for the requirements of non-destructive testing. The selected class depends on the radiation energy, penetrated material thickness and the quality level of the original radiographic film. This European Standard does not address signal processing, display and storage of the digitised data.

  • Standard
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This document describes a procedure for the control of film processing systems.

  • Standard
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Establishes a system for the classification of intra-oral radiographic film. Specifies the sensitometric characteristics of the film systems and the physical characteristics of the film.

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  • Standard
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The purpose of this standard is to fix the performance of film systems.
This standard is applicable for the classification of film systems in combination with specified lead screens for industrial radiography (non-destructive testing). This standard is intended to assure that the image quality of radiographs – as far as this is influenced by the film system – is in conformity with the requirements of European Standards such as EN 444, EN 1435 and EN 12681. This European Standard does not apply to the classification of films used with fluorescent intensifying screens. The measurement of film systems in this standard is restricted to a selected radiation quality to simplify the procedure. The properties of films will change with radiation energy but not the ranking of film system quality.
Additional methods for evaluating the photographic process are described in EN 584-2 by which the performance of film systems can be controlled under the conditions given in industry.

  • Standard
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The purpose of this standard is to describe a procedure for the control of the film processing systems by users by processing calibrated pre-exposed strips. The strips are exposed to X-rays and are accompanied by a certificate from the film strip manufacurer.  The user processes the pre-exposed strips in his system and records the results.  In this standard, clause 4 shows the responsability of the film strip manufacturer.  The user is responsible for clauses 5 to 8 which show compliance with the chosen system classification.

  • Standard + National Annex and/or Foreword
    12 pages
    Foreword and/or annex in Slovenian language, body of the standard in English language
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The purpose of this standard is to fix the performance of film systems. This standard is applicable for the classification of film systems in combination with specified lead screens for industrial radiography (non-destructive testing). This standard is intended to assure that the image quality of radiographs - as far as this is influenced by the film system - is in conformity with the minimum requirements of European standards such as EN 444. This European standard does not apply to the classification of films used with fluorescent intensifying screens.

  • Standard
    8 pages
    English language
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  • Standard
    9 pages
    English language
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  • Standard
    10 pages
    French language
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  • Standard
    5 pages
    English language
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  • Standard
    4 pages
    French language
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Establishes a system for the classification of intra-oral radiographic film. Specifies the sensitometric characteristics of the film systems and the physical characteristics of the film.

  • Standard
    8 pages
    English language
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  • Standard
    11 pages
    English language
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