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ASTM E2210-06

(Specification)

Standard Specification for Guideline Elements Model version 2 (GEM II)-Document Model for Clinical Practice Guidelines

Standard Specification for Guideline Elements Model version 2 (GEM II)-Document Model for Clinical Practice Guidelines

ABSTRACT
This specification updates a standard representation for storing and organizing the heterogeneous information contained in clinical practice guidelines, intended to facilitate translation of natural-language guideline documents into a format that can be processed by computers. This specification is based on the guideline elements model version 2 (GEM II) created at the Yale Center for Medical Informatics by health services researchers and informatics specialists, and designed to serve as a comprehensive XML-based guideline document representation.
SCOPE
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 Schema This specification defines a standard Schema for clinical practice guidelines. The Schema is included in Annex A1.
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.

General Information

Status
Historical
Publication Date
30-Nov-2006
ICS
35.240.80 - IT applications in health care technology
Technical Committee
E31 - Healthcare Informatics
Drafting Committee
E31.35 - Healthcare Data Analysis
Current Stage
Ref Project

Relations

Replaces
ASTM E2210-02 - Standard Specification for Guideline Elements Model (GEM)-Document Model for Clinical Practice Guidelines
Effective Date
01-Dec-2006

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ASTM E2210-06 - Standard Specification for Guideline Elements Model version 2 (GEM II)-Document Model for Clinical Practice GuidelinesASTM E2210-06 - Standard Specification for Guideline Elements Model version 2 (GEM II)-Document Model for Clinical Practice Guidelines
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ASTM E2210-06 - Standard Specification for Guideline Elements Model version 2 (GEM II)-Document Model for Clinical Practice Guidelines
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
An American National Standard
Designation: E2210 – 06
Standard Specification for
Guideline Elements Model version 2 (GEM II)—Document
1
Model for Clinical Practice Guidelines
This standard is issued under the fixed designation E2210; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope* platform-independent data access via XML, or for marking up
a given type of SGML document.
1.1 This specification updates a standard representation for
3.1.2 extensible markup language (XML)—standard from
storing and organizing the heterogeneous information con-
the World Wide Web Consortium (W3C) that provides for
tained in clinical practice guidelines. This specification is
tagging of information content within documents, offering a
intended to facilitate translation of natural-language guideline
means of representation of content in a format that is both
documents into a formatthatcanbeprocessedbycomputers.It
humanandmachinereadable.Throughtheuseofcustomizable
can be used to represent document content throughout the
style sheets and schemas, information can be represented in a
entire guideline life cycle. Information at both high and low
uniform way, allowing for interchange of both content (data)
levels of abstraction can be accommodated. This specification
and format (metadata).
is based on the guideline elements model (GEM) created at the
3.1.3 health level 7 (HL7)—a standards organization tradi-
Yale Center for Medical Informatics and designed to serve as
tionally focused on standards for healthcare information inter-
a comprehensive XML-based guideline document representa-
change. HL7 messages are the dominant standard for peer-to-
tion.
peer exchange of clinical text-based information. More
1.2 Thisspecificationreferstoandmakesuseofrecommen-
2
recently, HL7 has developed a comprehensive object model of
dations from the World Wide Web consortium, the W3C.
the healthcare enterprise and the first level of an XML clinical
1.3 Standard Guideline Schema—This specification defines
document architecture.
astandardSchemaforclinicalpracticeguidelines.TheSchema
3.1.4 HL7 clinical document architecture (CDA)—a docu-
is included in Annex A1.
ment markup standard for the structure and semantics of
1.4 This standard does not purport to address all of the
exchanged clinical documents. A clinical document is a docu-
safety concerns, if any, associated with its use. It is the
mentation of observations and other services with the follow-
responsibility of the user of this standard to establish appro-
ing characteristics: persistence, stewardship, potential for au-
priate safety and health practices and determine the applica-
thentication, wholeness, and human readability. A CDA
bility of regulatory requirements prior to use.
documentisadefinedandcompleteinformationobjectthatcan
2. Referenced Documents exist outside of a message and can include text, sounds, and
other multimedia content.
2.1 W3C World Wide Web Consortium:
3
3.1.5 hypertext markup language (HTML)—the language
XML 1.0 Recommendation
4
used in creating a web page. Its origin is an implementation of
XML Schema 1.0
SGML DTD. It provides tags regarding the way a document
3. Terminology
should be displayed in the text of an HTML document, which
act as commands that a browser interprets when downloading
3.1 Definitions:
an HTML file.
3.1.1 document type definition (DTD)—the formal defini-
3.1.6 namespaces—provide a simple method for qualifying
tion of the elements, structures, and rules for enabling
element and attribute names used in XML documents. This is
accomplished by associating a particular tag set by associating
a prefix with a URI reference. XML namespaces provides a
1
This specification is under the jurisdiction of ASTM Committee E31 on
mechanism for authoring compound documents (documents
Healthcare Informatics and is the direct responsibility of Subcommittee E31.35 on
consisting of elements and attributes from multiple DTDs or
Healthcare Data Analysis.
schemas) in such a way that will provide global identification
Current edition approved Dec. 1, 2006. Published January 2007. Originally
approved in 2002. Last previous edition approved in 2002 as E2210 – 02. DOI:
without collisions of names that are the same but are used
10.1520/E2210-06.
differently.
2
http://www.w3.org
3 3.1.7 parser—a specialized software program that recog-
http://www.w3.org/XML/
4
http://www.w3.org/XML/Schema nizesmarkupinadocumentanddifferentiatesthecontentfrom
*A Summary of Changes section appears at the end of this standard.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, We
...

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ASTM E2147-18(Specification)
Standard Specification for Audit and Disclosure Logs for Use in Health Information Systems

ABSTRACT
This specification describes the security requirements involved in the development and implementation of audit and disclosure logs used in health information systems. It specifies how to design an access audit log to record all access to patient identifiable information maintained in computer systems, and includes principles for developing policies, procedures, and functions of health information logs to document all disclosure of confidential health care information to external users for use in manual and computer systems. This specification provides for two main purposes, namely: to define the nature, role, and function of system access audit logs and their use in health information systems as a technical and procedural tool to help provide security oversight; and to identify principles for establishing a permanent record of disclosure of health information to external users and the data to be recorded in maintaining it.
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4.1 Data that document health services in health care organizations are business records and shall be archived to a secondary but retrievable medium, and readily accessible, such as data that would be archived in a server or cloud storage. Audit data shall be retained for as long as the medical record is maintained, and may not be destroyed before the medical record may legally be destroyed, and in any event, for at least 10 years or for two years after the legal age of majority, unless a longer period of record retention is prescribed by state, federal or other law or regulation.  
4.2 The purpose of audit data and disclosure logs is to document and maintain a permanent, trustworthy, and immutable record of all authorized and unauthorized activities of any nature whatsoever and disclosure of confidential health information {except exclusions per federal and state law [21 CFR 11 Subpart B(e)]}. This further facilitates the purpose that patients, healthcare providers, organizations, and others can obtain a verifiable, self-authenticating record documenting all activities with respect to that record. The process of information disclosure and auditing shall also conform, where relevant, with the Privacy Act of 1974 (3).  
4.3 Audit reports designed for system access provide a precise capability for healthcare providers, organizations, patients, patient representatives, and advocates to see who has accessed and/or manipulated patient information. Because of the significant risk of medical information manipulation in computing environments by authorized and unauthorized users, the audit report is an important management tool to monitor access and any such manipulation retrospectively. In addition, the access and disclosure logs become powerful support documents for disciplinary and legal actions. Moreover, audit reports are essential components to comprehensive security programs in healthcare and vital for the privacy rights of the individual. A patient has a right to ...
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1.1 This specification is for the development and implementation of secure audit data and logs for electronically stored health information. It specifies how to design the audit log to record all activities impacting a medical record, for example, creating a new record, entering data into a record, changing or deleting an existing record, and all additional user access data (for example, identification, location, and date and time) to patient-identifiable information maintained in computer systems. Such audit logs shall track not only data entry and modifications, but also simple access and viewing of the patient record, and whether any modifications are made during that access. This specification also includes principles for developing policies, procedures, and functions of health information logs to document all actions regarding identifiable health information for use in both manually entered (paper record) and computer systems.  
1.2 The first purpose of this specification is to defin...

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ASTM E3398-23(Guide)
Standard Guide for Digital Neutron Radiography

SIGNIFICANCE AND USE
4.1 Purpose—Practices to be employed for the radiographic examination of materials and components with neutrons using digital neutron detectors are outlined herein. They are intended as a guide for the assessment of a digital neutron radiograph’s characteristics. For information on neutron beam lines for imaging and film neutron radiography, refer to Guide E748.  
4.2 Limitations—Acceptance standards have not been established for any material or production process. Neutron radiography, whether performed by means of a reactor, an accelerator, subcritical assembly, or radioactive source, will be consistent in sensitivity and spatial resolution only if the consistency of all details of the technique, such as neutron source, collimation, geometry, imaging system, etc., are maintained. This guide is limited to the use of digital neutron detectors in combination with neutron conversion materials for image recording. This guide is intended for use with thermal and cold neutron spectrums. The production of thermal neutron radiographs by employing the use of film and appropriate conversion screens is covered in Guide E748.  
4.3 Interpretation and Acceptance Standards—Interpretat- ion and acceptance standards are not covered by this guide. Designation of accept-reject standards is recognized to be within the cognizance of product specifications.  
4.4 Other Aspects of the Neutron Radiographic Process—For many important aspects of neutron radiography such as technique, files, viewing of radiographs, storage of radiographs, film processing, and record keeping, refer to Guide E94, which covers these aspects for X-ray radiography. (See Section 2.)
SCOPE
1.1 This guide covers the evaluation, qualification, and quantification of digital neutron images. These images can be acquired by many methods, including: neutron sensitive imaging plates (Computed Radiography – CR), Digital Detector Arrays – DDA’s (amorphous silicon, CMOS, CCD, etc.), micro-channel plates, neutron sensitive fluoroscopes, neutron sensitive scintillators coupled to optical cameras, digitized radiographic films, and linear diode arrays.  
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1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
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1.5 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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ASTM E2699-23(Practice)
Standard Practice for Digital Imaging and Communication in Nondestructive Evaluation (DICONDE) for Digital X-ray (DX) Test Methods

SIGNIFICANCE AND USE
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, provides 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.
SCOPE
1.1 This practice covers the interoperability of digital X-ray imaging equipment using Digital Detector Arrays (DDA) as described in Practice E2698 by specifying image data transfer and archival methods in commonly accepted terms. A separate practice, Practice E2738, addresses this topic for digital X-ray imaging equipment using Computed Radiography (CR). 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 DICOM NEMA PS3 / ISO 12052 (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.  
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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 Units—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.  
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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.
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3.1 The primary use of this guide is to provide a standardized approach for the data file to be used for the transfer of digital radiological data from one user to another where the two users are working with dissimilar systems. This guide describes the contents, both required and optional for an intermediate data file that can be created from the native format of the radiological system on which the data was collected and that can be converted into the native format of the receiving radiological data analysis system. This guide will also be useful in the archival storage and retrieval of radiological data as either a data format specifier or as a guide to the data elements which should be included in the archival file.  
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SCOPE
1.1 This guide provides a listing and description of the fields that are recommended for inclusion in a digital radiological examination data base to facilitate the transfer of such data. This guide sets guidelines for the format of data fields for computerized transfer of digital image files obtained from radiographic, radioscopic, computed radiographic, or other radiological examination systems. The field listing includes those fields regarded as necessary for inclusion in the data base: (1) regardless of the radiological examination method (as indicated by Footnote C in Table 1), (2) for radioscopic examination (as indicated by Footnote F in Table 1), and (3) for radiographic examination (as indicated by Footnote D in Table 1). In addition, other optional fields are listed as a reminder of the types of information that may be useful for additional understanding of the data or applicable to a limited number of applications.  
1.2 It is recognized that organizations may have in place an internal format for the storage and retrieval of radiological examination data. This guide should not impede the use of such formats since it is probable that the necessary fields are already included in such internal data bases, or that the few additions can easily be made. The numerical listing and its order indicated in this guide is only for convenience; the specific numbers and their order carry no inherent significance and are not part of the data file.  
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Standard Test Method for Measuring Accuracy After Mechanical Disturbances on Reference Frames of Computer Assisted Surgery Systems

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5.1 The purpose of this practice is to provide data that can be used for comparison and evaluation of the accuracy of different CAS systems.  
5.2 The use of CAS systems and robotic tracking 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.  
5.3 In order to make comparisons within and between systems, a standardized way of measuring and reporting point accuracy is needed. Parameters such as coordinate system, units of measure, terminology, and operational conditions must be standardized.
SCOPE
1.1 This standard will measure the effects on the accuracy of computer assisted surgery (CAS) systems of the environmental influences caused by equipment utilized for bone preparation during the intended clinical application for the system. The environmental vibration effect covered in this standard will include mechanical vibration from: cutting saw (sagittal or reciprocating), burrs, drills, and impact loading. The change in accuracy from detaching and re-attaching or disturbing a restrained connection that does not by design require repeating the registration process of a reference base will also be measured.  
1.2 It should be noted that one system may need to undergo multiple iterations (one for each clinical application) of this standard to document its accuracy during different clinical applications since each procedure may have different exposure to outside forces given the surgical procedure variability from one procedure to the next.  
1.3 All units of measure will be reported as millimeters for this standard.  
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 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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Standard Practice for Measurement of Positional Accuracy of Computer-Assisted Surgical Systems

SIGNIFICANCE AND USE
5.1 The purpose of this practice is to provide data that can be used for evaluation of the accuracy of different CAS systems.  
5.2 The use of surgical navigation and robotic positioning systems is becoming increasingly common. In order to make informed decisions about the suitability of such systems for a given procedure, their accuracy capability needs to be evaluated under clinical application and compared to the requirements. As the performance of a whole system is constrained by those of its subparts, a preliminary step must be to objectively characterize the accuracy of the tracking subsystem in a controlled environment under controlled conditions.  
5.3 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 measurement, terminology, and operational conditions must be standardized.
SCOPE
1.1 This document provides procedures for measurement and reporting of basic static performance of surgical navigation and/or robotic positioning devices under defined conditions. They can be performed on a subsystem (for example, tracking only) or a full computer-aided surgery system as would be used clinically. Testing a subsystem does not mean that the whole system has been tested. The functionality to be tested based on this practice is limited to the performance (accuracy in terms of bias and precision) of the system regarding point localization in space by means of a pointer. A point in space has no orientation; only multidimensional 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 pointer can produce errors. These errors and the pointer orientation 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 a system (for example, with different reference elements or pointers) and between different systems (for example, from different manufacturers). Parameters to be evaluated include (based upon the features of the system being evaluated):
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1.1.1 This method covers all configurations of the evaluated system as well as extreme placements across the measurement volume.  
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Standard Practice for Digital Imaging and Communication in Nondestructive Evaluation (DICONDE) for X-ray Computed Tomography (CT) Test Methods

SIGNIFICANCE AND USE
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.
SCOPE
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.  
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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 Units—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, 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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ASTM
ASTM E2891-20(Guide)
Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications

SIGNIFICANCE AND USE
4.1 A significant amount of data is generated during pharmaceutical development and manufacturing activities. The interpretation of such data is becoming increasingly difficult. Individual examination of the univariate process variables is relevant but can be significantly complemented by multivariate data analysis (MVDA). MVDA may be particularly appropriate for exploring and handling large sets of heterogenous data, mapping data of high dimensionality onto lower dimensional representations, exposing significant correlations among multivariate variables within a single data set or significant correlations among multivariate variables across data sets. MVDA may extract statistically significant information which may enhance process understanding, decision making in process development, process monitoring and control (including product release), product life-cycle management, and continuous improvement.  
4.2 MVDA is widely used in various industries including the pharmaceutical industry. To achieve a valid outcome, an MVDA model/application should incorporate the following:  
4.2.1 A predefined risk-based objective incorporating one or more relevant scientific hypotheses specific to the application;  
4.2.2 Sufficient relevant data of requisite quality covering the variance space encountered during intended use, that is, pharmaceutical development, or pharmaceutical manufacturing, or both;  
4.2.3 Appropriate data analysis and model utilization practices including considerations on testing, validation, and qualification of all new data prior to using a model to analyze it;  
4.2.4 Appropriately trained staff;  
4.2.5 Appropriate standard operating procedures; and  
4.2.6 Life-cycle management.  
4.3 This guide can be used to support data analysis activities associated with pharmaceutical development and manufacturing, process performance and product quality monitoring in manufacturing, as well as for troubleshooting and investigation events. Technical detai...
SCOPE
1.1 This guide covers the applications of multivariate data analysis (MVDA) to support pharmaceutical development and manufacturing activities. MVDA is one of the key enablers for process understanding and decision making in pharmaceutical development, and for the release of intermediate and final products after being validated appropriately using a science and risk-based approach.  
1.2 The scope of this guide is to provide general guidelines on the application of MVDA in the pharmaceutical industry. While MVDA refers to typical empirical data analysis, the scope is limited to providing a high level guidance and not intended to provide application-specific data analysis procedures. This guide provides considerations on the following aspects:  
1.2.1 Use of a risk-based approach (understanding the objective requirements and assessing the fit-for-use status);  
1.2.2 Considerations on the data collection and diagnostics used for MVDA (including data preprocessing and outliers);  
1.2.3 Considerations on the different types of data analysis, model testing, and validation;  
1.2.4 Qualified and competent personnel; and  
1.2.5 Life-cycle management of MVDA model.  
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.

  • Guide
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  • Guide
    7 pages
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ASTM
ASTM E1935-97(2019)(Test Method)
Standard Test Method for Calibrating and Measuring CT Density

SIGNIFICANCE AND USE
5.1 This test method allows specification of the density calibration procedures to be used to calibrate and perform material density measurements using CT image data. Such measurements can be used to evaluate parts, characterize a particular system, or compare different systems, provided that observed variations are dominated by true changes in object density rather than by image artifacts. The specified procedure may also be used to determine the effective X-ray energy of a CT system.  
5.2 The recommended test method is more accurate and less susceptible to errors than alternative CT-based approaches, because it takes into account the effective energy of the CT system and the energy-dependent effects of the X-ray attenuation process.
FIG. 1 Density Calibration Phantom  
5.3 This (or any) test method for measuring density is valid only to the extent that observed CT-number variations are reflective of true changes in object density rather than image artifacts. Artifacts are always present at some level and can masquerade as density variations. Beam hardening artifacts are particularly detrimental. It is the responsibility of the user to determine or establish, or both, the validity of the density measurements; that is, they are performed in regions of the image which are not overly influenced by artifacts.  
5.4 Linear attenuation and mass attenuation may be measured in various ways. For a discussion of attenuation and attenuation measurement, see Guide E1441 and Practice E1570.
SCOPE
1.1 This test method covers instruction for determining the density calibration of X- and γ-ray computed tomography (CT) systems and for using this information to measure material densities from CT images. The calibration is based on an examination of the CT image of a disk of material with embedded specimens of known composition and density. The measured mean CT values of the known standards are determined from an analysis of the image, and their linear attenuation coefficients are determined by multiplying their measured physical density by their published mass attenuation coefficient. The density calibration is performed by applying a linear regression to the data. Once calibrated, the linear attenuation coefficient of an unknown feature in an image can be measured from a determination of its mean CT value. Its density can then be extracted from a knowledge of its mass attenuation coefficient, or one representative of the feature.  
1.2 CT provides an excellent method of nondestructively measuring density variations, which would be very difficult to quantify otherwise. Density is inherently a volumetric property of matter. As the measurement volume shrinks, local material inhomogeneities become more important; and measured values will begin to vary about the bulk density value of the material.  
1.3 All values are stated in SI units.  
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 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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