37.040.25 - Radiographic films

Standard Practice for Determining Relative Image Quality Response of Industrial Radiographic Imaging Systems below 4 MeV

ASTM E746-23(Practice)

SIGNIFICANCE AND USE
4.1 This standard provides a practice for RIQR evaluations of film and non-film imaging systems when exposed through an absorber material. Three alternate data evaluation methods are provided in Section 9. Determining RIQR requires the comparison of at least two radiographs or radiographic processes whereby the relative degree of image quality difference may be determined using the EPS plaque arrangement of Fig. 1 as a relative image quality indicator (RIQI). In conjunction with the RIQI, a specified radiographic technique or method must be established and carefully controlled for each radiographic process. This practice is designed to allow the determination of subtle changes in EPS that may arise to radiographic imaging system performance levels resultant from process improvements/changes or change of equipment attributes. This practice does not address relative unsharpness of a radiographic imaging system as provided in Practice E2002. The common element with any relative comparison is the use of the same RIQI arrangement for both processes under evaluation.
4.2 In addition to the standard evaluation method described in Section 9, there may be other techniques/methods in which the basic RIQR arrangement of Fig. 1 might be utilized to perform specialized assessments of relative image quality performance. For example, other radiographic variables can be altered to facilitate evaluations provided these differences are known and documented for both processes. Where multiple radiographic process variables are evaluated, it is incumbent upon the user of this practice to control those normal process attributes to the degree suitable for the application. Specialized RIQR techniques may also be useful with micro focus X-ray, isotope sources of radiation or with the use of non-film radiographic imaging systems. RIQR may also be useful in evaluating imaging systems with alternate materials (RIQI and base plate) such as plastic, copper-nickel, or aluminum. When using any ...
SCOPE
1.1 This standard covers a practice whereby industrial radiographic imaging systems or techniques may be comparatively assessed using the concept of relative image quality response (RIQR). Changes within a radiographic technique such as film/detector types, distances, or filtering/collimation can be comparatively assessed using this standard. The RIQR method presented within this practice is based upon the use of equivalent penetrameter sensitivity (EPS) described within Practice E1025 and subsection 5.4 of this practice. Fig. 1 illustrates a relative image quality indicator (RIQI) that has four different plaque thicknesses (0.38 mm, 0.25 mm, 0.20 mm, and 0.13 mm (0.015 in., 0.010 in., 0.008 in., and 0.005 in.)) sequentially positioned (from top to bottom) on an absorber plate of a specified material and thickness. The four plaques contain a total of 14 different arrays of penetrameter-type hole sizes designed to render varied conditions of threshold visibility when exposed to the appropriate radiation. Each “EPS” array consists of 30 identical holes; thus, providing the user with a quantity of threshold sensitivity levels suitable for relative image qualitative response comparisons. There are two standard materials (steel and plastic) specified herein for the RIQI and absorber. For special applications the user may design a non-standard RIQI-absorber configuration; however the RIQI configuration shall be controlled by a drawing similar to Fig. 1. Use of a non-standard RIQI-absorber configuration shall be described in the user’s written technique and approved by the CEO.
1.2 This practice is not intended to qualify the performance of a specific radiographic technique nor for assurance that a radiographic technique will detect specific discontinuities in a specimen undergoing radiographic examination.
1.3 This practice is not intended to be used to classify or derive performance classification categories for radiog...

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8 pages
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30-Nov-2023
37.040.25
E07

SIST EN IEC 60601-2-43:2023(Main)

Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures (IEC 60601-2-43:2022)

EN IEC 60601-2-43:2023

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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EN IEC 60601-2-43:2023(Main)

Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures

SIST EN IEC 60601-2-43:2023

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

IEC 60601-2-43:2022(Main)

Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures

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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Standard Practice for Fabrication of Neutron Radiographic Sensitivity Indicators

ASTM E2023-22(Practice)

SIGNIFICANCE AND USE
5.1 The only truly valid image quality indicator is a material or component, equivalent to the part being neutron radiographed, with a known standard discontinuity, inclusion, omission, or flaw (reference standard comparison part). The SI is designed to substitute for the reference standard, providing qualitative information on hole and gap sensitivity in a single unit. Fabrication in accordance with this practice is vital for accurate and consistent measurements.
5.2 This practice shall be followed for the fabrication of all SIs to be used with Test Method E545 to determine image quality in direct thermal neutron radiography. Devices constructed to previous versions of this practice, or Test Method E545 for devices built between 1981 and 1991, can also be used.
SCOPE
1.1 This practice covers the fabrication of Sensitivity Indicators (SI), which can be used to determine the relative quality of film radiographic images produced by direct, thermal neutron radiographic examination.
1.2 Units—The values stated in inch-pound units are to be regarded as standard.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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8 pages
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30-Nov-2022
37.040.25
E07

ASTM E3327/E3327M-21(Guide)

Standard Guide for the Qualification and Control of the Assisted Defect Recognition of Digital Radiographic Test Data

SIGNIFICANCE AND USE
5.1 This guide describes the recommended procedure for using software to assist with the identification of indications in digital radiographic images. Some of the concepts presented may be appropriate for other nondestructive test methods.
5.2 When properly applied, the methods and techniques outlined in this guide offer radiographic testing practitioners the potential to improve inspection reliability, reduce inspection cycle time, and harness inspection statistics for improving manufacturing processes.
5.3 The typical goal of a nondestructive test is to identify flaws that exceed the acceptance criteria. Due to the variability and uncertainty present in any inspection process, acceptance thresholds are established so that some acceptable components are discarded in an effort to prevent parts with discontinuities that exceed the acceptance criteria from entering service. This type of error, called a false positive, is considered less critical than a false negative error which would allow a nonconforming part into service. A successful application of AssistDR minimizes the false positive rate while reducing the false negative rate to levels appropriate for the intended application. The methods and techniques described in this guide facilitate achieving this desired outcome.
5.4 With the advent of deep learning, convolutional neural networks, and other forms of artificial intelligence, scenarios become possible where an AssistDR system continues to evolve or learn after qualification for production use. This guide does not address learning-based AssistDR systems. This guide addresses only deterministic systems that have software code and parameters that are fixed after qualification. Note that this limitation does not prohibit the use of this guide for developing a qualification and usage strategy for software using deep learning technology. The training or learning process for the deep learning system would need to be completed before qualification and all ...
SCOPE
1.1 Assisted defect recognition (AssistDR) describes a class of computer algorithms that assist a human operator in making a determination about nondestructive test data. This guide uses the term AssistDR to describe those computer assisted evaluation algorithms and associated software. For the purposes of this guide, the usage of the words “defect,” “evaluate,” “evaluation,” etc., in no way implies that the algorithms are dispositioning or otherwise making an unaided final disposition. Depending on the application, AssistDR computer algorithms detect and optionally classify indications of defects, flaws, discontinuities, or other anomalous signals in the acquired images. Software that does make an unaided final disposition is classified as automated defect recognition (AutoDR). While the concepts discussed in this guide are pertinent to AutoDR applications, additional validation tests or controls may be necessary when implementing AutoDR.
1.2 This guide establishes the minimum considerations for the radiographical examination of components using AssistDR for non-film radiographic test data. Most of the examples and discussion in this guide are built around two-dimensional test data for simplicity. The principles can be applied to three (volumetric computed tomography, for example) or higher dimensional test data.
1.3 The methods and practices described in this guide are intended for the application of AssistDR where image analysis will aid a human operator in the detection and evaluation of indications. The degree to which AssistDR is integrated into the testing and evaluation process will help the user determine the appropriate levels of process qualification and control required. This guide is not intended for applications wishing to employ AutoDR in which there is no human review of the results.
1.4 This guide applies to radiographic examination using an X-ray source. Some of the concepts presented may be ap...

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ASTM ISO/ASTM51275-21(Practice)

Standard Practice for Use of a Radiochromic Film Dosimetry System

SIGNIFICANCE AND USE
4.1 The radiochromic film dosimetry system provides a means for measuring absorbed dose based on radiation-induced change in color using spectrophotometers, densitometers or scanned images.
4.2 Radiochromic film dosimetry systems are commonly used in industrial radiation processing, for example in the sterilization of medical devices and the irradiation of foods.
SCOPE
1.1 This is a practice for using radiochromic film dosimetry systems to measure absorbed dose in materials irradiated by photons or electrons in terms of absorbed dose to water. Radiochromic film dosimetry systems are generally used as routine dosimetry systems.
1.2 The radiochromic film dosimeter is classified as a type II dosimeter on the basis of the complex effect of influence quantities (see ISO/ASTM 52628).
1.3 This document is one of a set of standards that provides recommendations for properly implementing dosimetry in radiation processing, and describes a means of achieving compliance with the requirements of ISO/ASTM 52628 “Practice for Dosimetry in Radiation Processing” for a radiochromic film dosimetry system. It is intended to be read in conjunction with ISO/ASTM 52628.
1.4 This practice covers the use of radiochromic film dosimetry systems under the following conditions:
1.4.1 The absorbed dose range is 1 Gy to 150 kGy.
1.4.2 The absorbed dose rate is 1 × 10-2 to 1 × 1013 Gy·s-1 (1-4).2
1.4.3 The photon energy range is 0.1 to 50 MeV.
1.4.4 The electron energy range is 70 keV to 50 MeV.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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7 pages
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30-Sep-2021
17.240
37.040.25
E61

EN ISO 14096-2:2020(Main)

Non-destructive testing - Qualification of radiographic film digitisation systems - Part 2: Minimum requirements (ISO 14096-2:2005)

SIST EN ISO 14096-2:2020

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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03-Mar-2020
29-Sep-2020
37.040.25
CEN/TC 138

EN ISO 14096-1:2020(Main)

Non-destructive testing - Qualification of radiographic film digitisation systems - Part 1: Definitions, quantitative measurements of image quality parameters, standard reference film and qualitative control (ISO 14096-1:2005)

SIST EN ISO 14096-1:2020

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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03-Mar-2020
29-Sep-2020
37.040.25
CEN/TC 138

Standard Practice for Fabrication of the Neutron Radiographic Beam Purity Indicators

ASTM E2003-20(Practice)

SIGNIFICANCE AND USE
5.1 The BPI is designed to yield quantitative information concerning neutron beam and image system parameters that contribute to film exposure and, thereby, affect overall image quality. For proper measurements of film exposure due to the neutron beam constituents, the BPI must be fabricated in accordance with this practice.
5.2 This practice shall be followed for the fabrication of all Beam Purity Indicators to be used with Test Method E545 to determine image quality in direct thermal neutron radiography.
SCOPE
1.1 This practice covers the material and fabrication of a Beam Purity Indicator (BPI), which can be used to determine the relative quality of radiographic images produced by direct, thermal neutron radiographic examination.
1.2 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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3 pages
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31-May-2020
37.040.25
E07

SIST EN 60601-2-43:2010/A2:2020(Amendment)

Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures (IEC 60601-2-43:2010/A2:2019)

EN 60601-2-43:2010/A2:2020

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

Amendment
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SIST EN ISO 14096-1:2020(Main)

EN ISO 14096-1:2020

Standard
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29-Nov-2019
23-Apr-2020
19.100
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SIST EN ISO 14096-2:2020(Main)

Non-destructive testing - Qualification of radiographic film digitisation systems - Part 2: Minimum requirements (ISO 14096-2:2005)

EN ISO 14096-2:2020

Standard
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29-Nov-2019
23-Apr-2020
22-Apr-2020
19.100
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EN ISO 11699-2:2018(Main)

Non-destructive testing - Industrial radiographic films - Part 2: Control of film processing by means of reference values (ISO 11699-2:2018)

SIST EN ISO 11699-2:2018

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

Standard
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11-Sep-2018
30-Mar-2019
37.040.25
CEN/TC 138

SIST EN ISO 11699-2:2018(Main)

Non-destructive testing - Industrial radiographic films - Part 2: Control of film processing by means of reference values (ISO 11699-2:2018)

EN ISO 11699-2:2018

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

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23-Jul-2017
13-Nov-2018
19.100
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Non-destructive testing - Industrial radiographic films - Part 2: Control of film processing by means of reference values

ISO 11699-2:2018(Main)

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

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11 pages
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IEC

IEC 60601-2-43:2010/AMD1:2017(Amendment)

Amendment 1 - Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures

Standard
17 pages
English and French language
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Photography - Intra-oral dental radiographic film and film packets - Manufacturer specifications

SIST ISO 3665:2014

ISO 3665:2011

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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04-Feb-2014
37.040.25
GRT

Photography - Intra-oral dental radiographic film and film packets - Manufacturer specifications (ISO 3665:2011)

EN ISO 3665:2013(Main)

SIST EN ISO 3665:2013

Standard
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19-Mar-2013
29-Sep-2013
37.040.25
93/42/EEC
CEN/TC 55

SIST EN ISO 3665:2013(Main)

Photography - Intra-oral dental radiographic film and film packets - Manufacturer specifications (ISO 3665:2011)

EN ISO 3665:2013

Standard
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19-Dec-2012
21-May-2013
37.040.25
93/42/EEC
VAZ

EN ISO 11699-1:2011(Main)

Non-destructive testing - Industrial radiographic film - Part 1: Classification of film systems for industrial radiography (ISO 11699-1:2008)

SIST EN ISO 11699-1:2012

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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25-Oct-2011
29-Apr-2012
37.040.25
CEN/TC 138

SIST EN ISO 11699-1:2012(Main)

Non-destructive testing - Industrial radiographic film - Part 1: Classification of film systems for industrial radiography (ISO 11699-1:2008)

EN ISO 11699-1:2011

Standard
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30-May-2011
12-Mar-2012
19.100
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Photography — Intra-oral dental radiographic film and film packets — Manufacturer specifications

ISO 3665:2011(Main)

SIST ISO 3665:2014

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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9 pages
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9 pages
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18-Aug-2011
37.040.25
ISO/TC 42

Photography - Sensitometry of screen/film systems for medical radiography - Part 3: Determination of sensitometric curve shape, speed and average gradient for mammography

SIST ISO 9236-3:2011

ISO 9236-3:1999

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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16 pages
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30-May-2011
37.040.25
GRT

Photography - Industrial radiographic films - Determination of ISO speed, ISO average gradient and ISO gradients G2 and G4 when exposed to X- and gamma-radiation

SIST ISO 7004:2011

ISO 7004:2002

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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18 pages
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30-May-2011
37.040.25
GRT

Photography - Sensitometry of screen/film systems for medical radiography - Part 1: Determination of sensitometric curve shape, speed and average gradient

SIST ISO 9236-1:2011

ISO 9236-1:2004

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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20 pages
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30-May-2011
37.040.25
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IEC

IEC 60601-2-43:2010(Main)

Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures

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
108 pages
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Standard
227 pages
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Standard
264 pages
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Non-destructive testing - Industrial radiographic film - Part 1: Classification of film systems for industrial radiography

ISO 11699-1:2008(Main)

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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9 pages
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Standard
9 pages
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Standard
12 pages
Russian language
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Non-destructive testing - Qualification of radiographic film digitisation systems - Part 2: Minimum requirements

ISO 14096-2:2005(Main)

Standard
4 pages
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Standard
4 pages
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ISO 14096-1:2005(Main)

Standard
11 pages
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Standard
12 pages
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SIST EN ISO 4090:2004(Main)

Photography - Medical radiographic cassettes/screens/films and hard-copy imaging films - Dimensions and specifications (ISO 4090:2004)

EN ISO 4090:2004

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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31-Oct-2004
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VAZ

Photography - Medical radiographic cassettes/screens/films and hard-copy imaging films - Dimensions and specifications (ISO 4090:2004)

EN ISO 4090:2004(Main)

SIST EN ISO 4090:2004

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06-Apr-2004
30-Oct-2004
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CEN/SS S99

Photography - Sensitometry of screen/film systems for medical radiography - Part 1: Determination of sensitometric curve shape, speed and average gradient

ISO 9236-1:2004(Main)

SIST ISO 9236-1:2011

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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20 pages
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26-Jan-2004
37.040.25
ISO/TC 42

Photography — Industrial radiographic films — Determination of ISO speed, ISO average gradient and ISO gradients G2 and G4 when exposed to X- and gamma-radiation

ISO 7004:2002(Main)

SIST ISO 7004:2011

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02-Oct-2002
37.040.25
ISO/TC 42

Photography — Medical radiographic cassettes/screens/films and hard-copy imaging films — Dimensions and specifications

ISO 4090:2001(Main)

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).

Standard
30 pages
English language
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29-Aug-2001
37.040.25
ISO/TC 42

Photography — Industrial radiographic films (roll and sheet) and metal intensifying screens — Dimensions

ISO 5655:2000(Main)

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
8 pages
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04-Oct-2000
37.040.25
ISO/TC 42

Photography — Sensitometry of screen/film systems for medical radiography — Part 3: Determination of sensitometric curve shape, speed and average gradient for mammography

ISO 9236-3:1999(Main)

SIST ISO 9236-3:2011

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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16 pages
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03-Feb-1999
37.040.25
ISO/TC 42

Photography - Direct-exposing medical and dental radiographic film/process systems - Determination of ISO speed and ISO average gradient

ISO 5799:1991(Main)

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).

Standard
10 pages
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Standard
10 pages
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Standard
10 pages
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07-Aug-1991
37.040.25
ISO/TC 42

oSIST prEN ISO 14096-1:2025

prEN ISO 14096-1(Main)

This document 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 (see Annex B) 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 basic spatial resolution down to 10 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∙430) mm2.
This document does not address signal processing and display of the digitised data.

Draft
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Non-destructive testing - Qualification of radiographic film digitisation systems - Part 2: Minimum requirements (ISO/DIS 14096-2:2025)

prEN ISO 14096-2(Main)

oSIST prEN ISO 14096-2:2025

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

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oSIST prEN ISO 14096-2:2025(Main)

Non-destructive testing - Qualification of radiographic film digitisation systems - Part 2: Minimum requirements (ISO/DIS 14096-2:2025)

prEN ISO 14096-2

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20-Nov-2025
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oSIST prEN ISO 14096-1:2025(Main)

prEN ISO 14096-1

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SIST EN ISO 11699-2:2012(Main)

Non-destructive testing - Industrial radiographic films - Part 2: Control of film processing by means of reference values (ISO 11699-2:2011)

EN ISO 11699-2:2011

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

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EN ISO 11699-2:2011(Main)

Non-destructive testing - Industrial radiographic films - Part 2: Control of film processing by means of reference values (ISO 11699-2:1998)

SIST EN ISO 11699-2:2012

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

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25-Oct-2011
13-Apr-2025
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CEN/TC 138

EN 14096-1:2003(Main)

SIST EN 14096-1:2004

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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