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ASTM E2436-05(2010)

(Specification)

Standard Specification for the Representation of Human Characteristics Data in Healthcare Information Systems (Withdrawn 2017)

Standard Specification for the Representation of Human Characteristics Data in Healthcare Information Systems (Withdrawn 2017)

ABSTRACT
This specification presents the standardized representation for the content and structure of human characteristics data for use in healthcare information systems, and may be extended to apply to characteristics of non-human living things, such as in data systems supporting veterinary medicine. This specification covers the logical representation of human characteristics data for individuals and populations, and the physical representation of human characteristics at the data tier of healthcare information systems. Conversely, the following provisions are outside the scope of this specification: the standardization of policy or regulation concerning the employment of human characteristics data described in this specification; the establishment or standardization of legal constraints over the use of human characteristics in conjunction with healthcare clinical or business processes; and addressing or standardizing personal privacy, medicolegal, and system security provisions associated with documenting human characteristics or storing human characteristics data.
SIGNIFICANCE AND USE
This specification promotes the interoperability of health information systems through enabling a single uniform representation of human characteristics at the data layer of healthcare information systems architecture (See Fig. 1).
It presents a data structure that allows the recording, storage, editing, and retrieval of human characteristics independent of technology and the language, nationality, or culture of persons or organizations involved in healthcare processes.
The intended use of this specification is to promote interoperability at the physical data tier in healthcare information systems, and to enhance the design and development of data subsystems that contain human characteristics data for individuals and populations.
The data structures in this specification can be readily transformed into presentation layer structuresfor example, into XML for presentation in the ASTM Continuity of Care Record or the HL7 standard Clinical Document Architecture, or into standard HL7 2.x messages.
Clinical uses of this data structure include the classification and storage of human characteristics for individuals and populationsfor example, for use in clinical decision support and epidemiology to compare the individual to populations consistent with best clinical and scientific practices.
This specification may be extended for use in veterinary medicine as described in Appendix X1. This extension includes a genus/taxonomy reference and associative entities/tables as cited in ANSI/ADA Specification 1000. This allows the characterization of individual non-human living things, and the inclusion of those of different species into mixed herds.
SCOPE
1.1 This document presents a standardized representation for the content and structure of human characteristics data for use in healthcare information systems.
1.2 This specification may be extended to apply to characteristics of non-human living things, such as in data systems supporting veterinary medicine.
1.3 The following provisions are within the scope of this specification:
1.3.1 Logical representation of human characteristics data for individuals and populations.
1.3.2 Physical representation of human characteristics at the data tier of healthcare information systems.
1.4 The following provisions are outside the scope of this specification:
1.4.1 The standardization of policy or regulation concerning the employment of human characteristics data described in this specification.
1.4.2 The establishment or standardization of legal constraints over the use of human characteristics in conjunction with healthcare clinical or business processes.
1.4.3 Addressing or standardizing personal privacy, medicolegal, and system security provisions associated with documenting human characteristics or storing human characteristics data.
1.5 This standard does not purport ...

General Information

Status
Withdrawn
Publication Date
31-May-2010
Withdrawal Date
20-Apr-2017
ICS
35.240.80 - IT applications in health care technology
Technical Committee
E31 - Healthcare Informatics
Drafting Committee
E31.25 - Healthcare Data Management, Security, Confidentiality, and Privacy
Current Stage
Ref Project

Relations

Replaces
ASTM E2436-05 - Standard Specification for the Representation of Human Characteristics Data in Healthcare Information Systems
Effective Date
01-Jun-2010

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ASTM E2436-05(2010) - Standard Specification for the Representation of Human Characteristics Data in Healthcare Information Systems (Withdrawn 2017)ASTM E2436-05(2010) - Standard Specification for the Representation of Human Characteristics Data in Healthcare Information Systems (Withdrawn 2017)
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ASTM E2436-05(2010) - Standard Specification for the Representation of Human Characteristics Data in Healthcare Information Systems (Withdrawn 2017)
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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
Designation:E2436 −05 (Reapproved 2010) An American National Standard
Standard Specification for the
Representation of Human Characteristics Data in Healthcare
Information Systems
This standard is issued under the fixed designation E2436; 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.
INTRODUCTION
This document presents a standardized representation for the content and structure of human
characteristics data for use in electronic health records and healthcare information systems generally.
Many of the data available to clinicians, health researchers and educators, and healthcare planners
cannot be easily compared due to the variety in representing human characteristics. This document
standardizes the representation of these characteristics at the data tier of health information systems.
1. Scope responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
1.1 This document presents a standardized representation
bility of regulatory limitations prior to use.
for the content and structure of human characteristics data for
use in healthcare information systems.
2. Referenced Documents
1.2 This specification may be extended to apply to charac- 2
2.1 ASTM Standards:
teristics of non-human living things, such as in data systems
E1384 Practice for Content and Structure of the Electronic
supporting veterinary medicine.
Health Record (EHR)
1.3 The following provisions are within the scope of this
E1633 SpecificationforCodedValuesUsedintheElectronic
specification: Health Record
1.3.1 Logical representation of human characteristics data
E2145 Practice for Information Modeling
for individuals and populations.
2.2 ANSI Standards
1.3.2 Physical representation of human characteristics at the
ANSI 260.3-1993 Mathematical Signs and Symbols for Use
data tier of healthcare information systems.
in Physical Sciences and Technology (revision and redes-
ignation of ANSI/ASME Y10.20-1990).
1.4 The following provisions are outside the scope of this
ANSI 1320.2-1998 IEEE Standard for Conceptual Model-
specification:
ing Language - Syntax and Semantics for IDEF1X97
1.4.1 Thestandardizationofpolicyorregulationconcerning
(IDEFobject)
the employment of human characteristics data described in this
ANSI/ADA 1000 Standard Data Architecture for the Struc-
specification.
ture and Content of the Electronic Health Record, Febru-
1.4.2 The establishment or standardization of legal con-
ary 2001.
straints over the use of human characteristics in conjunction
2.3 ISO Standards
with healthcare clinical or business processes.
ISO 639 Codesfortherepresentationofnamesoflanguages
1.4.3 Addressing or standardizing personal privacy,
ISO 2955 Representation of SI Units
medicolegal, and system security provisions associated with
ISO 5218 Representation of the Human Sexes
documenting human characteristics or storing human charac-
ISO 8601 Representation of Dates
teristics data.
2.4 Other Standards and Documents
1.5 This standard does not purport to address all of the
American Heritage Dictionary
safety concerns, if any, associated with its use. It is the
ANSI/ADA Specification 1000 Implementation Guide
HL7 2.x reference values.
This specification is under the jurisdiction of ASTM Committee E31 on
Healthcare Informatics and is the direct responsibility of Subcommittee E31.25 on
Healthcare Data Management, Security, Confidentiality, and Privacy. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved June 1, 2010. Published September 2010. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 2005. Last previous edition approved in 2005 as E2436–05. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/E2436-05R10. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E2436−05 (2010)
National Institute of Standards and Technology, Federal 3.3.4 Logical Data Model, n—A graphical and textual
Information Processing Standards Publications 184 Inte- representation of the data properties that describes a business
grated Definition for Information Modeling (IDEFIX), 23 function, process, or organization, consisting and all the
December 1993. relationships that exist among them.
3.3.5 Metadata, n—Data about data, or information about
3. Terminology
information, generally comprising a structured set of descrip-
3.1 Acronyms:
tive elements about any definable entity.
3.3.6 Physical Data Model, n—A graphical and textual
ADA = American Dental Association
representation of the structural properties that are implemented
ANSI = American National Standards Institute
CCR = ASTM standard Continuity of Care Record
or able to be implemented in a database, consisting of tables,
HL7 = Health Level Seven
columns and rows, and all the relationships that exist among
IDEF = Integrated Definition language
these.
ISO = International Standards Organization
3.3.7 Table, n—The basic unit of storage in a relational
LDM = Logical data model
database management system; in the physical data model
LOINC = Logical Observation Identifiers Names and Codes
analogous to the entity of the logical data model.
PDM = Physical data model
XML = Extensible Markup Language
4. Reference Data Model
3.2 Definitions:
4.1 This specification is based upon the ANSI/ADA Speci-
3.2.1 Ethnicity, n—characteristics of a group of people
fication 1000 reference data model and expands upon data
sharing a common and distinctive racial, national, religious,
structures found in the “Individual Characteristics” and “Popu-
linguistic, or cultural heritage.
lation Characteristics” subject areas.
American Heritage Dictionary
4.1.1 The Individual Characteristics subject area of this
3.2.2 Language, n—A system of arbitrary signals, such as
specification has been extended to include two additional
voice sounds, gestures, or written symbols, including its rules
entities/tables.
for combining its components, such as words, as used by a
4.1.1.1 Living Arrangement to allow the characterization
nation, people, or other distinct community for communication
and textual description of the residential life patterns and
of thoughts and feelings.
interpersonal life-dependencies of a patient or related indi-
American Heritage Dictionary
vidual.
4.1.1.2 Individual Physical Characteristics to allow docu-
3.2.3 LivingArrangement, n—Thesettingorenvironmentin
mentation of administrative characteristics (e.g. height, eye
which an individual lives, such as family setting, as may have
color, hair color, etc.) not otherwise documented in this model.
impact on the individual’s health and course of care.
4.1.2 Inthisspecification,severalattributesaredeletedfrom
3.2.4 Physical characteristic, n—a group of characteristics
the Individual entity that are not relevant to personal
previously used by convention as a means to describe an
characteristics, and this entity is extended by adding reported
individual, e.g. by hair color, eye color, build, etc.
and derived dates of birth and death.
3.2.5 Race, n—A local geographic or global human popu-
4.1.3 The following entities in theANSI/ADASpecification
lation distinguished as a more or less distinct group by
1000 Individual Characteristics subject area are not referenced
genetically transmitted physical characteristics.
in this specification:
American Heritage Dictionary
4.1.3.1 Individual Object is employed inANSI/ADASpeci-
3.2.6 Religion, n—A personal or institutionalized system
fication 1000 to carry object data descriptive of an individual
grounded in such belief and worship. A set of beliefs, values, such as an identification image or biometric data. This data is
and practices based on the teachings of a spiritual leader.
not considered as characteristics within the context of this
American Heritage Dictionary specification.
4.1.3.2 Individual Taxonomy associative entity is not used
3.2.7 Sex Characteristic, n—Preferred term to more com-
in human health information systems. Where this specification
pletely classify the multiple human sex characteristics. The
isextendedtorepresentthecharacteristicsofnon-humanliving
term “Sex” is preferred as the biologically correct term rather
things, the taxonomy or genus reference and associative
than the grammatical term “gender.”
entities may be employed.
3.3 Definitions:The following information modeling and
4.1.4 Associated Individual and Pair Bond Status are em-
technology terms are used in this document:
ployedinANSI/ADASpecification1000toallowtheconstruc-
3.3.1 Attribute, n—In a logical data model, an identifiable
tion of complex networks of interpersonal relationships, such
characteristic or data element of an entity.
as in an extended family or patterns of epidemiological
3.3.2 Column, n—In a database, a vertical space or dimen-
contacts.This specification does not address such relationships
sion in a database table that represents a particular domain of
as these concepts are subsequently covered in a separate
data and hold values for a particular attribute; in the physical
standard.
data model analogous to the attribute of the logical data model.
3.3.3 Entity, n—In a logical data model, a distinguishable
These modifications and extensions are under consideration for inclusion in the
object about which data is kept. next scheduled revision of ANSI/ADA Specification 1000.
E2436−05 (2010)
4.2 Both Logical and Physical Data Models are presented in populations—for example, for use in clinical decision support
Annex A1. and epidemiology to compare the individual to populations
4.2.1 Annex A1 illustrates the logical data model normal- consistent with best clinical and scientific practices.
izedtotheThirdNormalForm.Atthislevel,thedatastructures
5.3 This specification may be extended for use in veterinary
demonstrate the ability to connect the type of name element,
medicine as described in Appendix X1. This extension in-
such as family name, with its text value.
cludes a genus/taxonomy reference and associative entities/
4.2.2 Annex A1.6 illustrates a generic physical data model
tables as cited in ANSI/ADA Specification 1000. This allows
using Oracle 9.x datatypes.
thecharacterizationofindividualnon-humanlivingthings,and
4.3 The models illustrated in this document are presented in the inclusion of those of different species into mixed herds.
the ANSI standard IDEF1X data modeling notation.
6. Specification
4.4 Where the ANSI/ADA Specification 1000 data models
6.1 The logical data structure of a person’s characteristics is
have been enhanced, mixed case data names are employed to
composed of an association of reference entities with that
easily identify these changes.
person’s identifying entity, with the component attributes
reflecting the specific characteristics of the subject person. The
5. Significance and Use
structure and content of these associative entities varies with
5.1 This specification promotes the interoperability of
individuals and frequently over time. The physical structure
health information systems through enabling a single uniform
and content of these characteristics, along with reference data
representation of human characteristics at the data layer of
sources, are specified in Fig. A1.2.
healthcare information systems architecture (See Fig. 1).
It presents a data structure that allows the recording, storage, 6.2 Ageisaderivedvaluecalculatedusingthereporteddate
of birth; therefore, the individual’s age does not require data
editing, and retrieval of human characteristics independent of
technology and the language, nationality, or culture of persons storage as a separate item.
or organizations involved in healthcare processes.
6.3 The data structure in this specification provides a
5.1.1 The intended use of this specification is to promote
framework for recording or storing human characteristics data:
interoperability at the physical data tier in healthcare informa-
this specification does not mandate or require that any specific
tion systems, and to enhance the design and development of
human characteristic be obtained, recorded or stored in an
data subsystems that contain human characteristics data for
information system.
individuals and populations.
5.1.2 The data structures in this specification can be readily 7. Compliance
transformed into presentation layer structures—for example,
7.1 To be compliant with this specification, designers,
into XML for presentation in the ASTM Continuity of Care
developers, and vendors of healthcare applications and infor-
Record or the HL7 standard Clinical Document Architecture,
mationsystemsshalluseaphysicaldatastructurederivedfrom
or into standard HL7 2.x messages.
the generic physical data model presented in this specification.
5.2 Clinical uses of this data structure include the classifi- Physical data names and characteristics must be retained to
cation and storage of human characteristics for individuals and promote data interoperability.
FIG. 1Where This Specification Applies to System Architecture
E2436−05 (2010)
7.2 System designers and developers may adjust this ge- HL7 or LOINC, or the draft ASTM reference data for ANSI/
nericdatastructure,forexample,denormalize,forperformance ADA Specification 1000. Users should weigh the benefits of
and storage considerations as appropriate to their specific
usingthesereferencedataforinternaluseagainsttheimpacton
database management system.
achieving data interoperability across systems.
7.3 Systemdesigners,developers,andvendorsshouldtrans-
7.6 All database entries of these data must record the date
form these characteristics data for human interaction at the
and time of the observation (date-time stamp).
system presentation tier as appropriate to the ASTM CCR or
7.7 System designers, developers and vendors may extend
HL7 CDA standards.
the data structure beyond the representation in this specifica-
7.4 Systemdesigners,developers,andvendorsshouldtrans-
tion by including additional characteristics tables and data
form these characteristics data at the system presentation tier
elements.
for messaging between systems as appropriate to healthcare
7.7.1 ASTM Committee E31 should be notified of any
messaging standards, for example, HL7 2.x, ASTM, ANSI
X12N, NCPDP, etc. extension to these data structures for consideration in future
evolution of this standard.
7.5 System de
...

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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.
SCOPE
1.1 This practice covers 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 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 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, 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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