35.240.80 (IT applications in health care technolo 标准查询与下载

ASTM E1695-20 计算机断层扫描 (CT) 系统性能测量的标准试验方法

1.1 This test method provides instruction for determining the spatial resolution and contrast sensitivity in X-ray and γ-ray computed tomography (CT) volumes. The determination is based on examination of the CT volume of a uniform cylinder of material. The spatial resolution measurement (Modulation Transfer Function) is derived from an image analysis of the sharpness at the edges of the reconstructed cylinder slices. The contrast sensitivity measurement (Contrast Discrimination Function) is derived from an image analysis of the contrast and the statistical noise at the center of the cylinder slices. 1.2 This test method is more quantitative and less susceptible to interpretation than alternative approaches because the required cylinder is easy to fabricate and the analysis easy to perform. 1.3 This test method is not to predict the detectability of specific object features or flaws in a specific application. This is subject of IQI and RQI standards and standard practices. 1.4 This method tests and describes overall CT system performance. Performance tests of systems components such as X-ray tubes, gamma sources, and detectors are covered by separate documents, namely Guide E1000, Practice E2737, and Practice E2002; c.f. 2.1, which should be consulted for further system analysis. 1.5 Units—The values stated in SI units are to be regarded as standard. The values given in parentheses after SI units are provided for information only and are not considered standard. 1.6 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. 1.7 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.

Standard Test Method for Measurement of Computed Tomography (CT) System Performance

ASTM E2738-13 计算机射线成像40;CR41试验方法用数字成像与通信无损评价40;DICONDE41的标准实施规程

5.1 Personnel that are responsible for the creation, transfer, and storage of computed radiography NDE data will use this practice. This practice will define a set of information modules that along with the Practice E2339 and the DICOM standard will provide a standard means to organize CR inspection data. The CR inspection data may be displayed and analyzed on any device that conforms to the standard. Personnel wishing to view any CR inspection data stored in accordance with Practice E2339 may use this practice to help them decode and display the data contained in the DICONDE compliant inspection record. 1.1 This practice facilitates the interoperability of computed radiography (CR) imaging and data acquisition equipment by specifying image data transfer and archival storage methods in commonly accepted terms. This practice is intended to be used in conjunction with Practice E2339 on Digital Imaging and Communication in Nondestructive Evaluation (DICONDE). Practice E2339 defines an industrial adaptation of the NEMA Standards Publication titled Digital Imaging and Communications in Medicine (DICOM, see http://medical.nema.org), an international standard for image data acquisition, review, storage and archival storage. The goal of Practice E2339, commonly referred to as DICONDE, is to provide a standard that facilitates the display and analysis of NDE results on any system conforming to the DICONDE standard. Toward that end, Practice E2339 provides a data dictionary and a set of information modules that are applicable to all NDE modalities. This practice supplements Practice E2339 by providing information object definitions, information modules and a data dictionary that are specific to computed radiography test methods. 1.2 This practice has been developed to overcome the issues that arise when analyzing or archiving data from CR test equipment using proprietary data transfer and storage methods. As digital technologies evolve, data must remain decipherable through the use of open, industry-wide methods for data transfer and archival storage. This practice defines a method where all standard CR technique parameters and test results are communicated and stored in a standard manner regardless of changes in digital technology. 1.3 This practice does not specify: 1.3.1 A testing or validation procedure to assess an implementation's conformance to the standard. 1.3.2 The implementation details of any features of the standard on a device claiming conformance. 1.3.3 The overall set of features and functions to be expected from a system implemented by integrating a group of devices each claiming DICONDE conformance. 1.4 Although this practice contains no values that require units, it does describe methods to store and communicate data that do require units to be properly interpreted. The SI units required by this practice are to be regarded as standard. No other units of measurement are included in this practice. 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 and health practices and determine the applicability of regulatory limitations prior to use.

Standard Practice for Digital Imaging and Communication Nondestructive Evaluation 40;DICONDE41; for Computed Radiography 40;CR41; Test Methods

ASTM E1578-13 实验室信息的标准指南

4.1 Relevance—This guide is intended to educate those in the intended audience on many aspects of laboratory informatics. Specifically, the guide may: 4.1.1 Help educate new users of laboratory informatics; 4.1.2 Help educate general audiences in laboratories and other organizations that use laboratory informatics; 4.1.3 Help educate instrument manufactures and producers of other commonly interfaced systems; 4.1.4 Provide standard terminology that can be used by laboratory informatics vendors and end users; 4.1.5 Establish a minimum set of requirements for primary laboratory informatics functions; 4.1.6 Provide guidance on the tasks performed and documentation created in the specification, evaluation, cost justification, implementation, project management, training, and documentation of laboratory informatics; and 4.1.7 Provide high-level guidance for the integration of laboratory informatics. 4.2 How Used—This guide is intended to be used by all stakeholders involved in any aspect of laboratory informatics implementation, use or maintenance. 4.2.1 It is intended to be used throughout the laboratory informatics life cycle by individuals or groups responsible for laboratory informatics including specification, build/configuration, validation, use, upgrades, retirement/decommissioning. 4.2.2 It is also intended to provide an example of a laboratory informatics functions checklist. 1.1 This guide helps describe the laboratory informatics landscape and covers issues commonly encountered at all stages in the life cycle of laboratory informatics from inception to retirement. It explains the evolution of laboratory informatics tools used in today’s laboratories such as Laboratory Information Management Systems (LIMS), Electronic Laboratory Notebooks (ELN), Scientific Data Management Systems (SDMS), and Chromatography Data Systems (CDS). It also covers the relationship (interactions) between these tools and the external systems in a given organization. The guide discusses supporting laboratory informatics tools and a wide variety of the issues commonly encountered at different stages in the life cycle. The sub-sections that follow describe details of scope of this document in specific areas. 1.2 High-Level Purpose—The purpose of this guide includes: (1) helping educate new users of laboratory informatics tools, (2) provide a standard terminology that can be used by different vendors and end users, (3) establish minimum requirements for laboratory informatics, (4) provide guidance for the specification, evaluation, cost justification, implementation, project management, training, and documentation of the systems, and (5) provide function checklist examples for laboratory informatics systems that can be adopted within the laboratory and integrated with the existing systems.

Standard Guide for Laboratory Informatics

ASTM E2767-13 X射线极端及断层扫描40;CT41试验方法用无损评价数字成像与通信40;DICONDE41的标准实施规程

5.1 Personnel that are responsible for the creation, transfer, and storage of X-ray tomographic NDE data will use this standard. This practice defines a set of information modules that along with Practice E2339 and the DICOM standard provide a standard means to organize X-ray tomography test parameters and results. The X-ray CT test results may be displayed and analyzed on any device that conforms to this standard. Personnel wishing to view any tomographic inspection data stored according to Practice E2339 may use this document to help them decode and display the data contained in the DICONDE-compliant inspection record. 1.1 This practice facilitates the interoperability of X-ray computed tomography (CT) imaging equipment by specifying image data transfer and archival storage methods in commonly accepted terms. This document is intended to be used in conjunction with Practice E2339 on Digital Imaging and Communication in Nondestructive Evaluation (DICONDE). Practice E2339 defines an industrial adaptation of the NEMA Standards Publication titled Digital Imaging and Communications in Medicine (DICOM, see http://medical.nema.org), an international standard for image data acquisition, review, storage and archival storage. The goal of Practice E2339, commonly referred to as DICONDE, is to provide a standard that facilitates the display and analysis of NDE test results on any system conforming to the DICONDE standard. Toward that end, Practice E2339 provides a data dictionary and a set of information modules that are applicable to all NDE modalities. This practice supplements Practice E2339 by providing information object definitions, information modules and a data dictionary that are specific to X-ray CT test methods. 1.2 This practice has been developed to overcome the issues that arise when analyzing or archiving data from tomographic test equipment using proprietary data transfer and storage methods. As digital technologies evolve, data must remain decipherable through the use of open, industry-wide methods for data transfer and archival storage. This practice defines a method where all the X-ray CT technique parameters and test results are communicated and stored in a standard manner regardless of changes in digital technology. 1.3 This practice does not specify: 1.3.1 A testing or validation procedure to assess an implementation's conformance to the standard. 1.3.2 The implementation details of any features of the standard on a device claiming conformance. 1.3.3 The overall set of features and functions to be expected from a system implemented by integrating a group of devices each claiming DICONDE conformance. 1.4 Although this practice contains no values that require units, it does describe methods to store and communicate data that do require units to be properly interpreted. The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 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 and health practices and determine the applicability of regulatory limitations prior to use.

Standard Practice for Digital Imaging and Communication in Nondestructive Evaluation 40;DICONDE41; for X-ray Computed Tomography 40;CT41; Test Methods

ASTM E2699-13 数字射线成像40;DR41试验方法用无损评价数字成像与通信40;DICONDE41的标准实施规程

5.1 Personnel that are responsible for the creation, transfer, and storage of digital X-ray test results will use this standard. This practice defines a set of information modules that along with Practice E2339 and the DICOM standard provide a standard means to organize digital X-ray test parameters and results. The digital X-ray test results may be displayed and analyzed on any device that conforms to this standard. Personnel wishing to view any digital X-ray inspection data stored according to Practice E2339 may use this document to help them decode and display the data contained in the DICONDE-compliant inspection record. 1.1 This practice facilitates the interoperability of digital X-ray imaging equipment by specifying image data transfer and archival methods in commonly accepted terms. This document is intended to be used in conjunction with Practice E2339 on Digital Imaging and Communication in Nondestructive Evaluation (DICONDE). Practice E2339 defines an industrial adaptation of the NEMA Standards Publication titled Digital Imaging and Communications in Medicine (DICOM, see http://medical.nema.org), an international standard for image data acquisition, review, storage and archival storage. The goal of Practice E2339, commonly referred to as DICONDE, is to provide a standard that facilitates the display and analysis of NDE results on any system conforming to the DICONDE standard. Toward that end, Practice E2339 provides a data dictionary and a set of information modules that are applicable to all NDE modalities. This practice supplements Practice E2339 by providing information object definitions, information modules and a data dictionary that are specific to digital X-ray test methods. 1.2 This practice has been developed to overcome the issues that arise when analyzing or archiving data from digital X-ray test equipment using proprietary data transfer and storage methods. As digital technologies evolve, data must remain decipherable through the use of open, industry-wide methods for data transfer and archival storage. This practice defines a method where all the digital X-ray technique parameters and test results are communicated and stored in a standard manner regardless of changes in digital technology. 1.3 This practice does not specify: 1.3.1 A testing or validation procedure to assess an implementation's conformance to the standard. 1.3.2 The implementation details of any features of the standard on a device claiming conformance. 1.3.3 The overall set of features and functions to be expected from a system implemented by integrating a group of devices each claiming DICONDE conformance. 1.4 Although this practice contains no values that require units, it does describe methods to store and communicate data that do require units to be properly interpreted. The SI units required by this practice are to be regarded as standard. No other units of measurement are included in this standard. 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 and health practices and determine the applicability of regulatory limitations prior to use.

Standard Practice for Digital Imaging and Communication in Nondestructive Evaluation 40;DICONDE41; for Digital Radiographic 40;DR41; Test Methods

ASTM E2738-13e1 计算机射线成像40;CR41试验方法用数字成像与通信无损评价40;DICONDE41的标准实施规程

5.1 Personnel that are responsible for the creation, transfer, and storage of computed radiography NDE data will use this practice. This practice will define a set of information modules that along with the Practice E2339 and the DICOM standard will provide a standard means to organize CR inspection data. The CR inspection data may be displayed and analyzed on any device that conforms to the standard. Personnel wishing to view any CR inspection data stored in accordance with Practice E2339 may use this practice to help them decode and display the data contained in the DICONDE compliant inspection record. 1.1 This practice facilitates the interoperability of computed radiography (CR) imaging and data acquisition equipment by specifying image data transfer and archival storage methods in commonly accepted terms. This practice is intended to be used in conjunction with Practice E2339 on Digital Imaging and Communication in Nondestructive Evaluation (DICONDE). Practice E2339 defines an industrial adaptation of the NEMA Standards Publication titled Digital Imaging and Communications in Medicine (DICOM, see http://medical.nema.org), an international standard for image data acquisition, review, storage and archival storage. The goal of Practice E2339, commonly referred to as DICONDE, is to provide a standard that facilitates the display and analysis of NDE results on any system conforming to the DICONDE standard. Toward that end, Practice E2339 provides a data dictionary and a set of information modules that are applicable to all NDE modalities. This practice supplements Practice E2339 by providing information object definitions, information modules and a data dictionary that are specific to computed radiography test methods. 1.2 This practice has been developed to overcome the issues that arise when analyzing or archiving data from CR test equipment using proprietary data transfer and storage methods. As digital technologies evolve, data must remain decipherable through the use of open, industry-wide methods for data transfer and archival storage. This practice defines a method where all standard CR technique parameters and test results are communicated and stored in a standard manner regardless of changes in digital technology. 1.3 This practice does not specify: 1.3.1 A testing or validation procedure to assess an implementation's conformance to the standard. 1.3.2 The implementation details of any features of the standard on a device claiming conformance. 1.3.3 The overall set of features and functions to be expected from a system implemented by integrating a group of devices each claiming DICONDE conformance. 1.4 Although this practice contains no values that require units, it does describe methods to store and communicate data that do require units to be properly interpreted. The SI units required by this practice are to be regarded as standard. No other units of measurement are included in this practice. 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 and health practices and determine the applicability of regulatory limitations prior to use.

Standard Practice for Digital Imaging and Communication Nondestructive Evaluation 40;DICONDE41; for Computed Radiography 40;CR41; Test Methods

ASTM E1475-13 数字放射性检查数据的计算机化传输数据域的标准指南

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Standard Guide for Data Fields for Computerized Transfer of Digital Radiological Examination Data

ASTM E1672-12 计算机层析X射线摄影 (CT) 系统选择的标准指南

This guide will aid the purchaser in generating a CT system specification. This guide covers the conversion of purchaser's requirements to system components that must occur for a useful CT system specification to be prepared. Additional information can be gained in discussions with potential suppliers or with independent consultants. This guide is applicable to purchasers seeking scan services. This guide is applicable to purchasers needing to procure a CT system for a specific examination application.1.1 This guide covers guidelines for translating application requirements into computed tomography (CT) system requirements/specifications and establishes a common terminology to guide both purchaser and supplier in the CT system selection process. This guide is applicable to the purchaser of both CT systems and scan services. Computed tomography systems are complex instruments, consisting of many components that must correctly interact in order to yield images that repeatedly reproduce satisfactory examination results. Computed tomography system purchasers are generally concerned with application requirements. Computed tomography system suppliers are generally concerned with the system component selection to meet the purchaser's performance requirements. This guide is not intended to be limiting or restrictive, but rather to address the relationships between application requirements and performance specifications that must be understood and considered for proper CT system selection. 1.2 Computed tomography (CT) may be used for new applications or in place of radiography or radioscopy, provided that the capability to disclose physical features or indications that form the acceptance/rejection criteria is fully documented and available for review. In general, CT has lower spatial resolution than film radiography and is of comparable spatial resolution with digital radiography or radioscopy unless magnification is used. Magnification can be used in CT or radiography/radioscopy to increase spatial resolution but concurrently with loss of field of view. 1.3 Computed tomography (CT) systems use a set of transmission measurements made along a set of paths projected through the object from many different directions. Each of the transmission measurements within these views is digitized and stored in a computer, where they are subsequently conditioned (for example, normalized and corrected) and reconstructed, typically into slices of the object normal to the set of projection paths by one of a variety of techniques. If many slices are reconstructed, a three dimensional representation of the object is obtained. An in-depth treatment of CT principles is given in Guide E1441. 1.4 Computed tomography (CT), as with conventional radiography and radioscopic examinations, is broadly applicable to any material or object through which a beam of penetrating radiation may be passed and detected, including metals, plastics, ceramics, metallic/nonmetallic composite material and assemblies. The principal advantage of CT is that it has the potential to provide densitometric (that is, radiological density and geometry) images of thin cross sections through an object. In many newer systems the cross-sections are now combined into 3D data volumes for additional interpretation. Because of the absence of structural superposition, images may be much easier to interpret than conventional radiological images. The new purchaser can quickly learn to read CT data because images correspond more closely to the way the human mind visualizes 3D structures than conventional projection radiology. Further, because CT images are digital, the images may be enhanced, analyzed, compressed, archived, input as data into performance calculations, compared with digital data ......

Standard Guide for Computed Tomography (CT) System Selection

ASTM E2369-12 护理记录 (CCR) 连贯性的标准规范

1.1 The Continuity of Care Record (CCR) is a core data set of the most relevant administrative, demographic, and clinical information facts about a patient???s healthcare, covering one or more healthcare encounters.2 It provides a means for one healthcare practitioner, system, or setting to aggregate all of the pertinent data about a patient and forward it to another practitioner, system, or setting to support the continuity of care. 1.1.1 The CCR data set includes a summary of the patient???s health status (for example, problems, medications, allergies) and basic information about insurance, advance directives, care documentation, and the patient???s care plan. It also includes identifying information and the purpose of the CCR. (See 5.1 for a description of the CCR???s components and sections, and Annex A1 for the detailed data fields of the CCR.) 1.1.2 The CCR may be prepared, displayed, and transmitted on paper or electronically, provided the information required by this specification is included. When prepared in a structured electronic format, strict adherence to an XML schema and an accompanying implementation guide is required to support standards-compliant interoperability. The Adjunct3 to this specification contains a W3C XML schema and Annex A2 contains an Implementation Guide for such representation. 1.2 The primary use case for the CCR is to provide a snapshot in time containing the pertinent clinical, demographic, and administrative data for a specific patient. 1.2.1 This specification does not speak to other use cases or to workflows, but is intended to facilitate the implementation of use cases and workflows. Any examples offered in this specification are not to be considered normative.4 1.3 To ensure interchangeability of electronic CCRs, this specification specifies XML coding that is required when the CCR is created in a structured electronic format.5 This specified XML coding provides flexibility that will allow users to prepare, transmit, and view the CCR in multiple ways, for example, in a browser, as an element in a Health Level 7 (HL7) message or CDA compliant document, in a secure email, as a PDF file, as an HTML file, or as a word processing document. It will further permit users to display the fields of the CCR in multiple formats. 1.3.1 The CCR XML schema or .xsd (see the Adjunct to this specification) is defined as a data object that represents a snapshot of a patient???s relevant administrative, demographic, and clinical information at a specific moment in time. The CCR XML is not a persistent document, and it is not a messaging standard.Note 1???The CCR XML schema can also be used to define an XML representation for the CCR data elements, subject to the......

Standard Specification for Continuity of Care Record (CCR)

ASTM E2210-12 指南要素模型版本3(GEM III)的标准规范.临床实施规程指南用文件模型

1.1 This specification updates a standard representation for storing and organizing the heterogeneous information contained in clinical practice guidelines. This specification is intended to facilitate translation of natural-language guideline documents into a format that can be processed by computers. It can be used to represent document content throughout the entire guideline life cycle. Information at both high and low levels of abstraction can be accommodated. This specification is based on the guideline elements model (GEM) created at the Yale Center for Medical Informatics and designed to serve as a comprehensive XML-based guideline document representation. 1.2 This specification refers to and makes use of recommendations from the World Wide Web consortium, the W3C. 1.3 Standard Guideline Schema8212;This specification defines a standard Schema for clinical practice guidelines. The Schema is included in Annex A1. 1.4 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 and health practices and determine the applicability of regulatory requirements prior to use.

Standard Specification for Guideline Elements Model version 3 (GEM III)mdash;Document Model for Clinical Practice Guidelines

ASTM E2738-11 计算机X线摄影(CR)试验方法(DICONDE)用无损评估中数字成像和通信的标准操作规程

Personnel that are responsible for the creation, transfer, and storage of computed radiography NDE data will use this practice. This practice will define a set of information modules that along with the Practice E2339 and the DICOM standard will provide a standard means to organize CR inspection data. The CR inspection data may be displayed and analyzed on any device that conforms to the standard. Personnel wishing to view any CR inspection data stored in accordance with Practice E2339 may use this practice to help them decode and display the data contained in the DICONDE compliant inspection record.1.1 This practice facilitates the interoperability of computed radiography (CR) imaging and data acquisition equipment by specifying image data transfer and archival storage methods in commonly accepted terms. This practice is intended to be used in conjunction with Practice E2339 on Digital Imaging and Communication in Nondestructive Evaluation (DICONDE). Practice E2339 defines an industrial adaptation of the NEMA Standards Publication titled Digital Imaging and Communications in Medicine (DICOM, see http://medical.nema.org), an international standard for image data acquisition, review, storage and archival storage. The goal of Practice E2339, commonly referred to as DICONDE, is to provide a standard that facilitates the display and analysis of NDE results on any system conforming to the DICONDE standard. Toward that end, Practice E2339 provides a data dictionary and a set of information modules that are applicable to all NDE modalities. This practice supplements Practice E2339 by providing information object definitions, information modules and a data dictionary that are specific to computed radiography test methods. 1.2 This practice has been developed to overcome the issues that arise when analyzing or archiving data from CR test equipment using proprietary data transfer and storage methods. As digital technologies evolve, data must remain decipherable through the use of open, industry-wide methods for data transfer and archival storage. This practice defines a method where all standard CR technique parameters and test results are communicated and stored in a standard manner regardless of changes in digital technology. 1.3 This practice does not specify: 1.3.1 A testing or validation procedure to assess an implementation's conformance to the standard. 1.3.2 The implementation details of any features of the standard on a device claiming conformance. 1.3.3 The overall set of features and functions to be expected from a system implemented by integrating a group of devices each claiming DICONDE conformance. 1.4 Although this practice contains no values that require units, it does describe methods to store and communicate data that do require units to be properly interpreted. The SI units required by this practice are to be regarded as standard. No other units of measurement are included in this practice. 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 and health practices and determine th......

Standard Practice for Digital Imaging and Communication Nondestructive Evaluation (DICONDE) for Computed Radiography (CR) Test Methods

ASTM E1441-11 计算机断层扫描(CI)成像标准指南

This guide provides a tutorial introduction to the theory and use of computed tomography. This guide begins with a overview intended for the interested reader with a general technical background. Subsequent, more technical sections describe the physical and mathematical basis of CT technology, the hardware and software requirements of CT equipment, and the fundamental measures of CT performance. This guide includes an extensive glossary (with discussion) of CT terminology and an extensive list of references to more technical publications on the subject. Most importantly, this guide establishes consensus definitions for basic measures of CT performance, enabling purchasers and suppliers of CT systems and services to communicate unambiguously with reference to a recognized standard. This guide also provides a few carefully selected equations relating measures of CT performance to key system parameters. General Description of Computed Tomography8212;CT is a radiographic inspection method that uses a computer to reconstruct an image of a cross-sectional plane (slice) through an object. The resulting cross-sectional image is a quantitative map of the linear X-ray attenuation coefficient, μ, at each point in the plane. The linear attenuation coefficient characterizes the local instantaneous rate at which X-rays are removed during the scan, by scatter or absorption, from the incident radiation as it propagates through the object (See 7.5). The attenuation of the X-rays as they interact with matter is a well-studied problem (1) and is the result of several different interaction mechanisms. For industrial CT systems with peak X-ray energy below a few MeV, all but a few minor effects can be accounted for in terms of the sum of just two interactions: photoelectric absorption and Compton scattering (1). The photoelectric interaction is strongly dependent on the atomic number and density of the absorbing medium; the Compton scattering is predominantly a function of the electron density of the material. Photoelectric attenuation dominates at lower energies and becomes more important with higher atomic number, while Compton scattering dominates at higher energies and becomes more important at lower atomic number. In special situations, these dependencies can be used to advantage (see 7.6.2 and references therein). One particularly important property of the total linear attenuation coefficient is that it is proportional to material density, which is of course a fundamental physical property of all matter. The fact that CT images are proportional to density is perhaps the principal virtue of the technology and the reason that image data are often thought of as representing the distribution of material density within the object being inspected. This is a dangerous oversimplification, however. The linear attenuation coefficient also carries an energy dependence that is a function of material composition. This feature of the attenuation coefficient may or may not (depending on the materials and the energies of the X-rays involved) be more important than the basic density dependence. In some instances, this effect can be detrimental, masking the density differences in a CT image; in other instances, it can be used to advantage, enhancing the contrast between different materials of similar density. The fundamental difference between CT and conventional radiography is shown in Fig. 1. In conventional radiography, information on the slice plane “P” projects into a single line, “A-A;” whereas with the associated CT image, the full spatial information is preserved. CT information is derived from a large numbe............

Standard Guide for Computed Tomography (CT) Imaging

ASTM E2699-11 数字射线照相(DR)试验方法用无损评估(DICONDE)中的数字成像和通信的标准操作规程

Personnel that are responsible for the creation, transfer, and storage of digital X-ray test results will use this standard. This practice defines a set of information modules that along with Practice E2339 and the DICOM standard provide a standard means to organize digital X-ray test parameters and results. The digital X-ray test results may be displayed and analyzed on any device that conforms to this standard. Personnel wishing to view any digital X-ray inspection data stored according to Practice E2339 may use this document to help them decode and display the data contained in the DICONDE-compliant inspection record.1.1 This practice facilitates the interoperability of digital X-ray imaging equipment by specifying image data transfer and archival methods in commonly accepted terms. This document is intended to be used in conjunction with Practice E2339 on Digital Imaging and Communication in Nondestructive Evaluation (DICONDE). Practice E2339 defines an industrial adaptation of the NEMA Standards Publication titled Digital Imaging and Communications in Medicine (DICOM, see http://medical.nema.org), an international standard for image data acquisition, review, storage and archival storage. The goal of Practice E2339, commonly referred to as DICONDE, is to provide a standard that facilitates the display and analysis of NDE results on any system conforming to the DICONDE standard. Toward that end, Practice E2339 provides a data dictionary and a set of information modules that are applicable to all NDE modalities. This practice supplements Practice E2339 by providing information object definitions, information modules and a data dictionary that are specific to digital X-ray test methods. 1.2 This practice has been developed to overcome the issues that arise when analyzing or archiving data from digital X-ray test equipment using proprietary data transfer and storage methods. As digital technologies evolve, data must remain decipherable through the use of open, industry-wide methods for data transfer and archival storage. This practice defines a method where all the digital X-ray technique parameters and test results are communicated and stored in a standard manner regardless of changes in digital technology. 1.3 This practice does not specify: 1.3.1 A testing or validation procedure to assess an implementation's conformance to the standard. 1.3.2 The implementation details of any features of the standard on a device claiming conformance. 1.3.3 The overall set of features and functions to be expected from a system implemented by integrating a group of devices each claiming DICONDE conformance. 1.4 Although this practice contains no values that require units, it does describe methods to store and communicate data that do require units to be properly interpreted. The SI units required by this practice are to be regarded as standard. No other units of measurement are included in this standard. 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 and health practices and determine the applicab......

Standard Practice for Digital Imaging and Communication in Nondestructive Evaluation (DICONDE) for Digital Radiographic (DR) Test Methods

ASTM E2767-11 X线计算机断层(CT)试验方法用无损评估(DICONDE) 中数字成像与通信的标准操作规程

Personnel that are responsible for the creation, transfer, and storage of X-ray tomographic NDE data will use this standard. This practice defines a set of information modules that along with Practice E2339 and the DICOM standard provide a standard means to organize X-ray tomography test parameters and results. The X-ray CT test results may be displayed and analyzed on any device that conforms to this standard. Personnel wishing to view any tomographic inspection data stored according to Practice E2339 may use this document to help them decode and display the data contained in the DICONDE-compliant inspection record.1.1 This practice facilitates the interoperability of X-ray computed tomography (CT) imaging equipment by specifying image data transfer and archival storage methods in commonly accepted terms. This document is intended to be used in conjunction with Practice E2339 on Digital Imaging and Communication in Nondestructive Evaluation (DICONDE). Practice E2339 defines an industrial adaptation of the NEMA Standards Publication titled Digital Imaging and Communications in Medicine (DICOM, see http://medical.nema.org), an international standard for image data acquisition, review, storage and archival storage. The goal of Practice E2339, commonly referred to as DICONDE, is to provide a standard that facilitates the display and analysis of NDE test results on any system conforming to the DICONDE standard. Toward that end, Practice E2339 provides a data dictionary and a set of information modules that are applicable to all NDE modalities. This practice supplements Practice E2339 by providing information object definitions, information modules and a data dictionary that are specific to X-ray CT test methods. 1.2 This practice has been developed to overcome the issues that arise when analyzing or archiving data from tomographic test equipment using proprietary data transfer and storage methods. As digital technologies evolve, data must remain decipherable through the use of open, industry-wide methods for data transfer and archival storage. This practice defines a method where all the X-ray CT technique parameters and test results are communicated and stored in a standard manner regardless of changes in digital technology. 1.3 This practice does not specify: 1.3.1 A testing or validation procedure to assess an implementation's conformance to the standard. 1.3.2 The implementation details of any features of the standard on a device claiming conformance. 1.3.3 The overall set of features and functions to be expected from a system implemented by integrating a group of devices each claiming DICONDE conformance. 1.4 Although this practice contains no values that require units, it does describe methods to store and communicate data that do require units to be properly interpreted. The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 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 and health practices and determine the......

Standard Practice for Digital Imaging and Communication in Nondestructive Evaluation (DICONDE) for X-ray Computed Tomography (CT) Test Methods

ASTM F2554-10 计算机辅助外科系统定位精度的测量规程

The purpose of this practice is to provide data that can be used for evaluation of the accuracy of different CAS systems. The use of surgical navigation and robotic positioning systems is becoming increasingly common and requires a degree of trust by the user that the data provided by the system meets necessary accuracy requirements. In order to evaluate the potential use of these systems, and to make informed decisions about suitability of a system for a given procedure, objective performance data of such systems are necessary. While the end user will ultimately want to know the accuracy parameters of a system under clinical application, the first step must be to characterize the digitization accuracy of the tracking subsystem in a controlled environment under controlled conditions. In order to make comparisons within and between systems, a standardized way of measuring and reporting accuracy is needed. Parameters such as coordinate system, units of measure, terminology, and operational conditions must be standardized.1.1 This practice addresses the techniques of measurement and reporting of basic static performance (accuracy, repeatability, and so forth) of surgical navigation and/or robotic positioning devices under defined conditions. The scope covers the tracking subsystem, testing only in this practice the accuracy and repeatability of the system to locate individual points in space. A point in space has no orientation; only multi-dimensional objects have orientation. Therefore, orientation of objects is not within the scope of this practice. However, in localizing a point the different orientations of the localization tool can produce errors. These errors and the orientation of the localization tool are within the scope of this practice. The aim is to provide a standardized measurement of performance variables by which end-users can compare within (for example, different fixed reference frames or stylus tools) and between (for example, different manufacturers) different systems. Parameters to be evaluated include (based upon the features of the system being evaluated): (1) Location of a point relative to a coordinate system. (2) Relative point to point accuracy (linear). (3) Repeatability of coordinates of a single point. (4) For an optically based system, the range of visible orientations of the reference frames or tools. (5) This method covers all configurations of tool arrays in the system. 1.2 The system as defined in this practice includes only the tracking subsystem (optical, magnetic, mechanical, and so forth) stylus, computer, and necessary hardware and software. As such, this practice incorporates tests that can be applied to a prescribed phantom model in a laboratory or controlled setting. 1.3 This practice defines a standardized reporting format, which includes definition of the coordinate systems to be used for reporting the measurements, and statistical measures (for example, mean, standard deviation, maximum error). 1.4 This practice will serve as the basis for subsequent standards for specific tasks (cutting, drilling, milling, reaming, biopsy needle placement, and so forth) and surgical applications. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 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 and health practices and determine the applicability of regulatory limitations prior to use.

Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems

ASTM E1986-09 健康信息的信息访问特权的标准指南

The maintenance of confidentiality in paper-based, electronic, or computer-based health information requires that policies and procedures be in place to protect confidentiality. Confidentiality of information depends on structural and explicit mechanisms to allow persons or systems to define who has access to what, and in what situation that access is granted. For guidelines on the development and implementation of privilege management infrastructures supporting these mechanisms, see Guide E2595. Confidential protection of data elements is a specific requirement. The classification of data elements into restrictive and specifically controlled categories is set by policies, professional practice, and laws, legislation, and regulations. There are three explicit concepts upon which the use of and access to health information confidentiality are defined. Each of these concepts is an explicit and unique characteristic relevant to confidentiality, but only through the combination (convergence) of all three concepts can appropriate access to an explicit data element at a specific point in time be provided, and unauthorized access denied. The three concepts are: The categorization and breakdown of data into logical and reasonable elements or entities. The identification of individual roles or job functions. The establishment of context and conditions of data use at a specific point in time, and within a specific setting. The overriding principle in preserving the confidentiality of information is to provide access to that information only under circumstances and to individuals when there is an absolute, established, and recognized need to access that data, and the information accessed should itself be constrained only to that information essential to accomplish a defined and recognized task or process. Information nonessential to that task or process should ideally not be accessible, even though an individual accessing that information may have some general right of access to that information.1.1 This guide covers the process of granting and maintaining access privileges to health information. It directly addresses the maintenance of confidentiality of personal, provider, and organizational data in the healthcare domain. It addresses a wide range of data and data elements not all traditionally defined as healthcare data, but all elemental in the provision of data management, data services, and administrative and clinical healthcare services. In addition, this guide addresses specific requirements for granting access privileges to patient-specific health information during health emergencies. 1.2 This guide is based on long-term existing and established professional practices in the management of healthcare administrative and clinical data. Healthcare data, and specifically healthcare records (also referred to as medical records or patient records), are generally managed under similar professional practices throughout the United States, essentially regardless of specific variations in local, regional, state, and federal laws regarding rules and requirements for data and record management. 1.3 This guide applies to all individuals, groups, organizations, data-users, data-managers, and public and private firms, companies, agencies, departments, bureaus, service-providers, and similar entities that collect individual, group, and organizational data related to health care. 1.4 This guide applies to all collection, use, management, maintenance, disclosure, and access of all individual, group, and organizational data related to health care. 1.5 This guide does not attempt to address specific legislative and regulatory issues regarding individual, group, and organizational righ......

Standard Guide for Information Access Privileges to Health Information

ASTM E1931-09 X射线康普顿散射断层摄影的标准指南

Principal Advantage of Compton Scatter Tomography8212;The principal advantage of CST is the ability to perform three-dimensional X-ray examination without the requirement for access to the back side of the examination object. CST offers the possibility to perform X-ray examination that is not possible by any other method. The CST sub-surface slice image is minimally affected by examination object features outside the plane of examination. The result is a radioscopic image that contains information primarily from the slice plane. Scattered radiation limits image quality in normal radiographic and radioscopic imaging. Scatter radiation does not have the same detrimental effect upon CST because scatter radiation is used to form the image. In fact, the more radiation the examination object scatters, the better the CST result. Low subject contrast materials that cannot be imaged well by conventional radiographic and radioscopic means are often excellent candidates for CST. Very high contrast sensitivities and excellent spatial resolution are possible with CST tomography. Limitations8212;As with any nondestructive testing method, CST has its limitations. The technique is useful on reasonably thick sections of low-density materials. While a 25 mm (1 in.) depth in aluminum or 50 mm (2 in.) in plastic is achievable, the examination depth is decreased dramatically as the material density increases. Proper image interpretation requires the use of standards and examination objects with known internal conditions or representative quality indicators (RQIs). The examination volume is typically small, on the order of a few cubic inches and may require a few minutes to image. Therefore, completely examining large structures with CST requires intensive re-positioning of the examination volume that can be time-consuming. As with other penetrating radiation methods, the radiation hazard must be properly addressed.1.1 Purpose8212;This guide covers a tutorial introduction to familiarize the reader with the operational capabilities and limitations inherent in X-ray Compton Scatter Tomography (CST). Also included is a brief description of the physics and typical hardware configuration for CST. 1.2 Advantages8212;X-ray Compton Scatter Tomography (CST) is a radiologic nondestructive examination method with several advantages that include: 1.2.1 The ability to perform X-ray examination without access to the opposite side of the examination object; 1.2.2 The X-ray beam need not completely penetrate the examination object allowing thick objects to be partially examined. Thick examination objects become part of the radiation shielding thereby reducing the radiation hazard; 1.2.3 The ability to examine and image object subsurface features with minimal influence from surface features; 1.2.4 The ability to obtain high-contrast images from low subject contrast materials that normally produce low-contrast images when using traditional transmitted beam X-ray imaging methods; and 1.2.5 The ability to obtain depth information of object features thereby providing a three-dimensional examination. The ability to obtain depth information presupposes the use of a highly collimated detector system having a narrow angle of acceptance. 1.3 Applications8212;This guide does not specify which examination objects are suitable, or unsuitable, for CST. As with most nondestructive examination techniques, CST is highly application specific thereby requiring the suitability of the method to be first demonstrated in the application labor......

Standard Guide for X-Ray Compton Scatter Tomography

ASTM F2761-09 医疗器械和医疗系统.包含病人的设备用基础安全要求.中心综合临床环境(ICE).第1部分:一般要求和概念模型

This standard specifies general requirements, a model and framework for integrating equipment to create a INTEGRATED CLINICAL ENVIRONMENT (ICE), as defined in 3.6. This standard specifies the characteristics necessary for the safe integration of MEDICAL DEVICES and other equipment, via an electronic interface, from different MANUFACTURERS into a single medical system for the care of a single high acuity PATIENT. This standard establishes requirements for a medical system that is intended to have greater error resistance and improved PATIENT safety, treatment efficacy and workflow efficiency than can be achieved with independently used MEDICAL DEVICES.This series of standards establishes requirements for design, verification, and validation processes of a modelbased integration system for an INTEGRATED CLINICAL ENVIRONMENT. This series of standards is intended to define the requirements essential for safety and thereby facilitate regulatory acceptance. NOTE These requirements were derived to support the clinical scenarios or clinical concepts of operations described in Annex B.

Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model

ASTM F2761-09(2013) 医疗器械和医疗系统. 以患者为中心综合医疗环境(ICE)组成设备的基本安全要求. 第1部分: 一般要求和概念模型

This standard specifies general requirements, a model and framework for integrating equipment to create a INTEGRATED CLINICAL ENVIRONMENT (ICE), as defined in 3.6. This standard specifies the characteristics necessary for the safe integration of MEDICAL DEVICES and other equipment, via an electronic interface, from different MANUFACTURERS into a single medical system for the care of a single high acuity PATIENT. This standard establishes requirements for a medical system that is intended to have greater error resistance and improved PATIENT safety, treatment efficacy and workflow efficiency than can be achieved with independently used MEDICAL DEVICES.This series of standards establishes requirements for design, verification, and validation processes of a modelbased integration system for an INTEGRATED CLINICAL ENVIRONMENT. This series of standards is intended to define the requirements essential for safety and thereby facilitate regulatory acceptance. NOTE These requirements were derived to support the clinical scenarios or clinical concepts of operations described in Annex B.

Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model

ASTM E2145-07(2013) 信息建模用标准实施规程

5.1 Modeling is increasingly used in business, industry, and commerce to develop a common understanding of processes, functions, activities, and supporting data. Typical users of such models are systems developers, operations researchers and business analysts, educators, and executives. 5.1.1 Information models are regarded widely as beneficial by saving cost through realignment of processes, risk reduction and elimination of redundancy. Information models convey ideas and facilitate the analysis and understanding of complex processes and structures. These models form the basis for software engineering practices that build systems and databases, redefine organizational structures, improve business processes, and develop standards. 5.1.2 This practice provides a practical means for developers and users of information models to employ appropriate modeling methods and to objectively determine model quality. 5.2 Background: 5.2.1 Models are representations of past, existing, or contemplated reality. Models may assist in the explanation or analysis of complex structures and processes that may exceed human capacity for direct visualization or understanding. Models enable a focus on the key elements of a process or structure while ignoring confounding or irrelevant elements. As such, models make an explicit statement of the meaning of the reality being modeled. 5.2.2 Integrated information engineering models provide a coherent view of the processes and data of an organization or enterprise (5). Activity models identify the fundamental tasks performed in a function. Process models accurately describe the detailed collection of these activities within an organization. Data models are derived from and support the functions described in activity models. Object models also characterize the processes and data required to understand business operations. Both structured and object-oriented models may be used to construct information systems that support those business operations. Application models describe in varying levels of detail, the overall architecture and components of the software needed to support the envisioned business functions. Organizational models reflect the current and envisioned future state of the organization, especially as this impacts business processes enabled or supported by information systems. Location models identify and describe the business and geographic position and relationships of structural components of an organizational entity. Technology models describe in varying levels of detail those hardware, system software, and network components needed to operate the information systems supporting a business area. Models may be textual, graphic, or mixed graphic and text forms, including, tables and structured lists, flowcharts, process flow diagrams, state diagrams, data flow diagrams, entity-relationship diagrams, and related techniques develop an understanding of business processes and the transformation of data through these processes (6). Modeling products may also relate two or more types of models, such as for an Application-Data Matrix, or Technology-Location Plan. ......

Standard Practice for Information Modeling