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ASTM E2210-02

(Specification)

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

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

SCOPE
1.1 This specification covers a document type definition (DTD) that specifies 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 —DTDThis specification defines a standard DTD for clinical practice guidelines. The DTD 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.

General Information

Status
Historical
Publication Date
09-May-2002
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

Replaced By
ASTM E2210-06 - Standard Specification for Guideline Elements Model version 2 (GEM II)-Document Model for Clinical Practice Guidelines
Effective Date
01-Dec-2006

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ASTM E2210-02 - Standard Specification for Guideline Elements Model (GEM)-Document Model for Clinical Practice GuidelinesASTM E2210-02 - Standard Specification for Guideline Elements Model (GEM)-Document Model for Clinical Practice Guidelines
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ASTM E2210-02 - Standard Specification for Guideline Elements Model (GEM)-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: E 2210 – 02
Standard Specification for
Guideline Elements Model (GEM)—Document Model for
Clinical Practice Guidelines
This standard is issued under the fixed designation E 2210; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope E 2183 Guide for XML DTD Design, Architecture and
Implementation
1.1 This specification covers a document type definition
2.2 W3C World Wide Web Consortium:
(DTD) that specifies a standard representation for storing and
XML 1.0 Recommendation
organizing the heterogeneous information contained in clinical
XHTML Basic Recommendation
practice guidelines. This specification is intended to facilitate
XLINK
translation of natural-language guideline documents into a
Namespaces Recommendation
format that can be processed by computers. It can be used to
XSL/XSLT
represent document content throughout the entire guideline life
Schemas
cycle. Information at both high and low levels of abstraction
2.3 HL7 Standards:
can be accommodated. This specification is based on the
Informative Document: Using XML as anAlternative Mes-
guidelineelementsmodel(GEM)createdattheYaleCenterfor
sage Syntax for HL7, Version 2.3.x
Medical Informatics and designed to serve as a comprehensive
Clinical Document Architecture
XML-based guideline document representation.
1.2 Thisspecificationreferstoandmakesuseofrecommen-
3. Terminology
dations from the World Wide Web consortium, the W3C.
3.1 Definitions:
1.3 Standard Guideline DTD—This specification defines a
3.1.1 document type definition (DTD)—the formal defini-
standard DTD for clinical practice guidelines. The DTD is
tion of the elements, structures, and rules for enabling
included in Annex A1.
platform-independent data access via XML, or for marking up
1.4 This standard does not purport to address all of the
a given type of SGML document.
safety concerns, if any, associated with its use. It is the
3.1.2 extensible markup language (XML)—standard from
responsibility of the user of this standard to establish appro-
the World Wide Web Consortium (W3C) that provides for
priate safety and health practices and determine the applica-
tagging of information content within documents, offering a
bility of regulatory requirements prior to use.
means of representation of content in a format that is both
2. Referenced Documents human and machine readable.Through the use of customizable
style sheets and schemas, information can be represented in a
2.1 ASTM Standards:
uniform way, allowing for interchange of both content (data)
E 1239 Guide for Description of Reservation/Registration-
and format (metadata).
Admission, Discharge, Transfer (R-ADT) Systems for
3.1.3 health level 7 (HL7)—a standards organization tradi-
Automated Patient Care Information Systems
tionally focused on standards for healthcare information inter-
E 1384 Guide for Content and Structure of the Electronic
change. HL7 messages are the dominant standard for peer-to-
Health Record (EHR)
peer exchange of clinical text-based information. More
E 1633 Specification for Coded Values Used in the Elec-
recently, HL7 has developed a comprehensive object model of
tronic Health Record
E 2182 Specification for Clinical XML DTDs in Health-
care
http://www.w3.org/XML/
1 5
This specification is under the jurisdiction of ASTM Committee E31 on http://www.w3.org/TR/2000/REC-xhtml-basic-20001219
Healthcare Informatics and is the direct responsibility of Subcommittee E31.35 on http://www.w3.org/XML/Linking
Healthcare Data Analysis. http://www.w3.org/TR/REC-xml-names/
Current edition approved May 10, 2002. Published August 2002. http://www.w3.org/Style/XSL/
2 9
http://www.w3.org http://www.w3.org/XML/Schema
3 10
Annual Book of ASTM Standards, Vol 14.01. http://www.HL7.org
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
E2210–02
the healthcare enterprise and the first level of an XML clinical and tools) to lead the Web to its full potential as a forum for
document architecture. information, commerce, communication, and collective under-
3.1.4 HL7 clinical document architecture (CDA)—a docu- standing.
ment markup standard for the structure and semantics of 3.1.13 XHTML—HTML documents that are well formed
exchanged clinical documents. A clinical document is a docu- and can be processed by an XML parser.
mentation of observations and other services with the follow- 3.1.14 XLL/XLINK/XPOINTER—XLL, the extensible link-
ing characteristics: persistence, stewardship, potential for au- ing language, is divided into two parts, XLinks and XPointers.
thentication, wholeness, and human readability. A CDA XLink, the XML linking language, defines how one document
documentisadefinedandcompleteinformationobjectthatcan links to another document. XPointer, the XML pointer lan-
exist outside of a message and can include text, sounds, and guage, defines how individual parts of a document are ad-
other multimedia content. dressed. XLinks point to a URI (in practice, a URL) that
3.1.5 hypertext markup language (HTML)—the language specifies a particular resource. The URL may include an
used in creating a web page. Its origin is an implementation of XPointer part that more specifically identifies the desired part
SGML DTD. It provides tags regarding the way a document or section of the targeted resource or document. XPointer, the
should be displayed in the text of an HTML document, which XML pointer language, defines an addressing scheme for
act as commands that a browser interprets when downloading individual parts of an XML document. XLinks point to a URI
an HTML file. (in practice, a URL) that specifies a particular resource. The
3.1.6 namespaces—provide a simple method for qualifying URI may include an XPointer part that more specifically
element and attribute names used in XML documents. This is identifies the desired part or element of the targeted resource or
accomplished by associating a particular tag set by associating document. XPointers use the same XPath syntax as XSL
a prefix with a URI reference. XML namespaces provides a transformationstoidentifythepartsofthedocumenttheypoint
mechanism for authoring compound documents (documents to, along with a few additional pieces.
consisting of elements and attributes from multiple DTDs or 3.2 Definitions of Terms Specific to This Standard:
schemas) in such a way that will provide global identification 3.2.1 clinical practice guidelines—systematically devel-
without collisions of names that are the same but are used oped statements to assist practitioner and patient decisions
differently. about appropriate healthcare for specific clinical circum-
3.1.7 parser—a specialized software program that recog- stances.
nizes markup in a document and differentiates the content from 3.2.2 guideline elements model (GEM)—an XML-based
the markup.Aparser that reads a DTD and checks and reports guideline document model that promotes translation of natural
on markup errors is a validating XML parser. A parser can be language guideline documents into a format that can be
built into an XML editor to prevent incorrect tagging and to processed by computers. Developed at the Yale Center for
check whether a document contains all the required elements. Medical Informatics, GEM serves as the basis for this speci-
3.1.8 schema—defines the elements that can appear within fication.
the document and the attributes that can be associated with an 3.2.3 guidelines interchange format (GLIF)—a proposed
element. It also defines the structure of the document: which representation for guideline logic created by the INTERMED
elements are child elements of others, the sequence in which Collaboratory.
the child elements can appear, and the number of child 3.2.4 national guidelines clearinghouse (NGC)—a website
elements.Itdefineswhetheranelementisemptyorcaninclude sponsored by the U.S. Agency for Healthcare Quality and
text. The schema can also define default values for attributes. Researchthatdisseminatesinformationaboutqualifyingguide-
Schema is a W3C term for the next generation of DTDs. lines. It includes a structured vocabulary for describing several
3.1.9 stylesheet—the XSL transformations (XSLT) de- aspects of guidelines.
scribes a vocabulary recognized by an XSLT processor to 3.3 GEM Definitions:
transform information from an organization in the source file 3.3.1 See Table A1.1 in Annex A1.
into a different organization suitable for continued downstream
4. Significance and Use
processing. The extensible stylesheet language (XSL) de-
scribes a vocabulary recognized by a rendering agent to reify 4.1 GEM Representation—The guideline elements model
abstract expressions of format into a particular medium of (GEM) was created to unify representations created by health
presentation. services researchers and by informatics specialists. Specifica-
3.1.10 valid XML document—a document that is well- tion E 2210 DTD is based on the GEM knowledge represen-
formed, with internal or DOCTYPE reference to element tation. It is intended to be:
definition of tags within the document.
3.1.11 well-formed XML document—an XML document
Guidelines for Clinical Practice: From Development to Use, Institute of
that conforms to the syntax as specified by the W3C XML 1.0
Medicine, National Academy Press, Washington, DC, 1992.
recommendation.
http://ycmi.med.yale.edu
3.1.12 World Wide Web Consortium (W3C)—develops in-
http://www.glif.org.
teroperable technologies (specifications, guidelines, software, http://www.guideline.gov
E2210–02
4.1.1 Comprehensive, that is, capable of expressing all the contain content or serve as XLinks to external content. Addi-
knowledge contained in a guideline. Existing health services tionally the DTD may make use of namespaces to resolve
models of guidelines are inadequate for expressing the com- conflicts with other XML standards and XHTML tags.
plexity of knowledge components in sufficient detail to facili-
5.2 GEM Architecture—The root level of this Specification
tate electronic translations. On the other hand, existing infor-
E 2210 DTD is the guideline document. At the next tier, the
matics models are insufficient to model constructs that express
model defines header and body elements. The and support guideline validity. Lack of confidence in the
.header> includes identity and developer elements. The
validity of guideline recommendations may ultimately limit
includes purpose, ,
end user adherence.
, , 4.1.2 Expressively adequate to express the complexities and
.components>, testing, and revision elements. Each of these
nuances of clinical medicine while remaining informationally
elements comprises one or more additional levels of guideline
equivalent to the original guideline. Most tagged elements in
constructs.
the Specification E 2210 DTD store the actual language of the
5.3 Elements—Elements can appear as often as required.
guideline, thereby remaining true to the original. Moreover,
Most elements store information that is literally presented in
this DTD does not require recommendation knowledge to be
the guideline text itself, for example, release date, name of
structured in a temporal sequence, an often artificial transfor-
sponsoring organization, and recommendation text. A small
mation necessary for algorithmic representations.
number of metalevel tags provide information about the
4.1.3 Flexible, that is, a useful model must be able to deal
guideline that has been interpreted, for example, with the variety and complexity of guidelines. The representa-
.type>. To distinguish whether an element’s content is explic-
tion should permit modeling at high and low levels of
itlystatedwithintheguidelinedocumentorwasinferredbythe
granularity so that guidelines can be interpreted at different
person who performed the markup, each element has an
levels of abstraction. The Specification E 2210 DTD allows
attribute called “source.” The source attribute can take values
markupusinghigh-leveltagsordeeperanalysisusingelements
of “explicit,” “inferred,” or in some cases “NGC” (to indicate
from lower levels in the hierarchy. In addition, the open XML
that the National Guidelines Clearinghouse structured vocabu-
document model can be modified easily if necessary to
lary is used).
accommodate missing semantic constructs.
5.4 Identity—Information that identifies a particular guide-
4.1.4 Comprehensible, that is, it should match the stake-
line document and describes it in general terms is clustered
holders’ normal problem-solving language and allow domain
within this construct. The identity element includes the guide-
experts to describe their knowledge with little effort. The
line’s complete title, a citation that references its publication,
Specification E 2210 DTD markup does not require knowledge
its , its availability (in electronic and print
of programming. The markup process parallels physical high-
formats) and a person or organization to be contacted for
lighting of a document and should be learned easily by
further information. The status element indicates whether the
nonprogrammers.
guideline has been updated or revised. Since many current
4.1.5 Shareable across institutions. The use of XML for
guidelines are released as packages that may include patient
knowledge representation and markup provides unparalleled
educationmaterials,foreignlanguageversions,quickreference
cross-platform compatibility.
guides, and technical reports, a construct for 4.1.6 Reusable across all phases of the guideline life cycle.
.document> is included. An entry stored in the adaptation
4.2 Conformance—A document is tested for conformance
element identifies whether the guideline has been adapted from
to this specification by a validating XML parser according to
another publication.
theW3CXML1.0recommendation. Aconformantdocument
5.5 Developer—The organization responsible for develop-
mustvalidatewithouteitherwell-formednessorvalidityerrors,
ment of the guideline is identified and described. A according to XML 1.0. A conformant document must also
er.type> element (for example, medical specialty society,
conform to constraints expressed within the prose of this
federal government agency, managed care organization) pro-
specification; however, this specification does not expr
...

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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, 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 E1475-13(2023)(Guide)
Standard Guide for Data Fields for Computerized Transfer of Digital Radiological Examination Data

SIGNIFICANCE AND USE
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.  
3.2 Although the recommended field listing includes more than 100 field numbers, only about half of those are regarded as essential and are marked Footnote C in Table 1. Fields so marked must be included in the data base. The other fields recommended provide additional information that a user will find helpful in understanding the radiological image and examination result. These header field items will, in most cases, make up only a very small part of a radiological examination file. The actual stream of radiological data that make up the image will take up the largest part of the data base. Since a radiological image file will normally be large, the concept of data compression will be considered in many cases. Compressed data should be noted, along with a description of the compression method, as indicated in Field No. 92 (see Table 1). (A) Field numbers are for reference only. They do not imply a necessity to include all these fields in any specific data base nor imply a requirement that fields used be in this particular order.(B) Units listed first are SI; those in parentheses are inch-pound (English).(C) Denotes essential field for computerization of examination results, regardless of examination method.(D) Denotes essential field for radiogra...
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.  
1.3 Current users of Guide E1475 do not have to change their software. First time users should use the XML structure of Table A1.1 for their data.  
1.4 The types of radiological examination systems that appear useful in relation to this guide include radioscopic systems as described in Guide E1000, Practices E1255, E1411, E2597, E2698 and E2737, and radiographic systems as described in Guide E94 and Practices E748, E1742, E2033, E2445, and E2446. Many of the terms used are def...

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ASTM F3107-14(2023)(Test Method)
Standard Test Method for Measuring Accuracy After Mechanical Disturbances on Reference Frames of Computer Assisted Surgery Systems

SIGNIFICANCE AND USE
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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ASTM F2554-22(Practice)
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):
(1) Accuracy of a single point relative to a coordinate system.
(2) Sensitivity of tracking accuracy due to changes in pointer orientation.
(3) Relative point-to-point accuracy.  
1.1.1 This method covers all configurations of the evaluated system as well as extreme placements across the measurement volume.  
1.2 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, RMS, and maximum error).  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard, except for angular measurements, which may be reported in terms of radians or degrees.  
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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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.

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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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