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ASTM E2473-05

(Practice)

Standard Practice for the Occupational/Environmental Health View of the Electronic Health Record

Standard Practice for the Occupational/Environmental Health View of the Electronic Health Record

SCOPE
1.1 This Practice is intended to assemble a logical occupational/environmental health view of the already defined general structure and vocabulary for the Electronic Health Record (EHR) and to suggest the ways in which this view can be used to support employee health assessments and other healthcare delivered at the work site. This view is consistent with the ANSI/ADA Clinical Concept Data Model 2005, which identified the major data entities that will need to be involved. This view would complement other views addressed in other settings of care for the employee and could logically either request other EHR data or deliver to other practitioner requesters record systems portions of occupational/environmental health data that have been recorded at the work site. This practice does not deal with the specific implementation of the content and it also does not either suggest or recommend implementation techniques. Likewise, it does not suggest standards of care. These functions are dealt with in other domains.

General Information

Status
Historical
Publication Date
14-Nov-2005
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

Replaced By
ASTM E2473-05(2011) - Standard Practice for the Occupational/Environmental Health View of the Electronic Health Record (Withdrawn 2020)
Effective Date
01-May-2011

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ASTM E2473-05 - Standard Practice for the Occupational/Environmental Health View of the Electronic Health Record
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: E2473 – 05
Standard Practice for the
Occupational/Environmental Health View of the Electronic
Health Record
This standard is issued under the fixed designation E2473; 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 E1715 Practice forAn Object-Oriented Model for Registra-
tion, Admitting, Discharge, and Transfer (RADT) Func-
1.1 This Practice is intended to assemble a logical
tions in Computer-Based Patient Record Systems
occupational/environmental health view of the already defined
E1744 Practice for View of Emergency Medical Care in the
general structure and vocabulary for the Electronic Health
Electronic Health Record
Record (EHR) and to suggest the ways in which this view can
E1762 Guide for Electronic Authentication of Health Care
be used to support employee health assessments and other
Information
healthcare delivered at the work site. This view is consistent
E1869 Guide for Confidentiality, Privacy,Access, and Data
withtheANSI/ADAClinicalConceptDataModel2005,which
Security Principles for Health Information Including Elec-
identified the major data entities that will need to be involved.
tronic Health Records
This view would complement other views addressed in other
E1986 Guide for Information Access Privileges to Health
settings of care for the employee and could logically either
Information
request other EHR data or deliver to other practitioner request-
E1987 Guide for Individual Rights Regarding Health Infor-
er’s record systems portions of occupational/environmental
mation
health data that have been recorded at the work site. This
E1988 Guide for Training of Persons who have Access to
practice does not deal with the specific implementation of the
Health Information
content and it also does not either suggest or recommend
E2017 Guide for Amendments to Health Information
implementation techniques. Likewise, it does not suggest
E2066 Guide for Validation of Laboratory Information
standards of care. These functions are dealt with in other
Management Systems
domains.
E2084 Specification forAuthentication of Healthcare Infor-
2. Referenced Documents
mation Using Digital Signatures
E2085 Guide on Security Framework for Healthcare Infor-
2.1 ASTM Standards:
mation
E1239 PracticeforDescriptionofReservation/Registration-
E2086 Guide for Internet and Intranet Healthcare Security
Admission, Discharge, Transfer (R-ADT) Systems for
E2145 Practice for Information Modeling
Electronic Health Record (EHR) Systems
E2147 Specification forAudit and Disclosure Logs for Use
E1340 GuideforRapid Prototyping of InformationSystems
in Health Information Systems
E1384 Practice for Content and Structure of the Electronic
E2171 Practice for Rating-Scale Measures Relevant to the
Health Record (EHR)
Electronic Health Record
E1578 Guide for Laboratory Information Management Sys-
2.2 ANSI/IEEE Standards:
tems (LIMS)
ANSI/IEEE 610.2 Standard Glossary of ComputerApplica-
E1633 Specification for Coded Values Used in the Elec-
tions Terminology
tronic Health Record
ANSI/IEEE 610.5 Standard Glossary of Information Man-
E1714 Guide for Properties of a Universal Healthcare
agement Terminology
Identifier (UHID)
ANSI/IEEE 610.12 Standard Glossary of Software Engi-
neering Terminology
ANSI/IEEE 729 Fundamental Terms in Software Engineer-
This practice is under the jurisdiction ofASTM Committee E31 on Healthcare
ing
Informatics and is the direct responsibility of Subcommittee E31.25 on Healthcare
Data Management, Security, Confidentiality, and Privacy.
Current edition approved July 17, 2006. Published December 2005. DOI:
10.1520/E2473-05.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Withdrawn. The last approved version of this historical standard is referenced
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM on www.astm.org.
Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
E2473 – 05
ANSI/IEEE 830 Software Requirements Specification ANSI X3.172 American National Dictionary for Informa-
ANSI/IEEE 1058 Software Project Management Plans tion Systems
ANSI/ADA TR 1039 2005 Clinical Content Data Model
ANSI/IEEE 1062 Recommended Practice for Software Re-
quirements ANSI/ADA 1000.0 Introduction, Model Architecture, and
ANSI/IEEE 1063 Software User Documentation Specification Framework
ANSI/ADA 1000.1 Individual Identification
ANSI/IEEE 1073 Framework and Overview
ANSI/ADA 1000.2 Codes and Nomenclature
ANSI/IEEE 1073.2 Application Profile Framework and
Overview ANSI/ADA 1000.3 Individual Characteristics
ANSI/IEEE 1073.3.1 Transport Profile ANSI/ADA 1000.4 Population Characteristics
ANSI/ADA 1000.5 Organization
ANSI/IEEE 1073.4.1 Physical Layer-Cable Connected
ANSI/IEEE 1074 Standard for Developing Life Cycle Pro- ANSI/ADA 1000.6 Location
cesses ANSI/ADA 1000.7 Communication
ANSI/IEEE 1074.1 Guide for Developing Life Cycle Pro- ANSI/ADA 1000.8 Healthcare Event
cesses ANSI/ADA 1000.9 Health Materiel
ANSI/IEEE 1220 Standard for Application and Manage- ANSI/ADA 1000.10 Health Services
ment of the System Engineering Process
ANSI/ADA 1000.11 Health Service Resources
ANSI/IEEE 1233 Guide to Preparing System Requirements
ANSI/ADA 1000.12 Population Health Facts
Specifications ANSI/ADA 1000.13 Patient Health Facts
ANSI/IEEE 1320.1 Standard for Conceptual Modeling
ANSI/ADA 1000.14 Health Condition Diagnosis
Language—Syntax and Semantics for IDEF0
ANSI/ADA 1000.15 Health Service Plan
ANSI/IEEE 1320.2 Standard for Conceptual Modeling
ANSI/ADA 1000.16 Patient Health Service
Language—Syntax and Semantics for IDEF1X97 (IDEF
ANSI/ADA 1000.17 Clinical Investigation
Object)
ANSI/ADA 1000.18 Comments Subject Area
ANSI/IEEE 1362 Guide for Information Technology—
DICOM Supplement 15 Visible Light Image, Anatomic
System Definition—Concept of Operations Document
Frame of Reference, Accession and Specimen for Endos-
ANSI/IEEE 1490 Guide to Project Management Body of
copy, Microscopy, and Photography
Knowledge
CEN ENV 1613 Medical Informatics—Messages for the
ANSI/IEEE 1498 Trial Use Standard for Information
Exchange of Laboratory Information
Technology—Software LifeCycle Processes—Software
CEN ENV 1614 Healthcare Informatics—Structure for No-
Development: Acquirer—Supplier Agreement
menclature, Classification and Coding of Properties in
ANSI/IEEE 12207.0 Standard for Information
Clinical Laboratory Sciences
Technology—Software Life Cycle Processes
CEN EN 12017 Medical Informatics Vocabulary (MIVoc)
ANSI/IEEE 12207.1 Guide for Information Technology—
CEN EN 12264 Categorical Structures of Systems of
Software Life Cycle Processes—Life Cycle Data
Concepts—Model for Representation of Semantics
ANSI/IEEE 12207.2 Guide for Information Technology—
(MOSE)
Software Life Cycle Processes—Implementation Consid-
Internet RFC 1521 N. Borenstein, N Freed MIME [Multi-
erations
purpose Internet Mail Extensions] Purpose: Mechanisms
IEEE P1157.1 Trial Use Standard for Healthcare Data
for Specifying and Designating the Format of Internet
Interchange—Information Model Methods
Message Bodies Bellcore Innosoft Sep 1993
2.3 ANSI/HL7 Standards:
ANSI X12
ANSI/HL7 Interface Standard v2.4
CLSI AUTO1-A Laboratory Automation: Specimen
HL7 Message Development Framework v 3.0 Jan 1997
Container/Specimen Carrier
2.4 ISO Standards:
CLSI AUTO2-A Laboratory Automation: Bar codes for
ISO/IEC TR 9789 Information Technology—Guidelines for
Specimen Container Identification
the Organization and Representation of Data Elements for
CLSI AUTO3-A Laboratory Automation: Communications
Data Interchange—Coding Methods and Principles
with Automated Clinical Laboratory Systems, Instru-
ISO 12200 Computer Applications in Terminology—
ments, Devices and Information Systems
Machine-Readable Terminology Interchange Format
CLSI AUTO4-A Laboratory Automation: Systems Opera-
(MARTIF)—Negotiated Interchange
tional Requirements, Characteristics and Information El-
ISO 12620 Computer Applications in Terminology—Data ements
Categories
CLSI AUTO5-A Laboratory Automation: Electromechani-
ISO IS 12207 Information Technology-Software Life Cycle
cal Interfaces
Processes ANSI/ CLSI ASTP2 Point of Care In-vitro Diagnostic
ISO IS 15188 Project Management Guidelines for Termi-
Testing
nology Standardization
ANSI/CLSI GP19 Laboratory Instruments and Data Man-
ISO WD 15288 System Life Cycle Processes agement Systems: Design of Software User Interfaces and
ISO 15440 Guide for Life Cycle Processes Software Systems Validation, Operations and Mainte-
2.5 Other Standards: nance
E2473 – 05
CLSILIS-3A(priorASTME792) GuideforProcurementof 3.2.20 NCVHS—National Committee on Vital and Health
a Clinical Laboratory Information Management System Statistics
(CLIMS) 3.2.21 NIOSH—National Institute for Occupational Safety
CLSI LIS-5A(priorASTM E1238) Specification for Trans- and Health
ferring Clinical Observations Between Independent Com- 3.2.22 NPF—National Provider File
puter Systems 3.2.23 NPI—National Provider Identifier
CLSI LIS-1A (prior ASTM E1381) Specification for Low 3.2.24 NPS—National Provider System
Level Protocol to Transfer Messages Between Clinical 3.2.25 OSHA—OccupationalSafetyandHealthAdministra-
Laboratory Instruments and Computer Systems tion
CLSI LIS-2A(priorASTM E1394) Specification for Trans- 3.2.26 POC—Point-of-Care
ferring Information Between Clinical Instruments and 3.2.27 POCT—Point-of-Care Testing
Computer Systems 3.2.28 PPO—Preferred Provider Organization
CLSI LIS-7A(priorASTM E1466) Specification for Use of 3.2.29 SSAN—Social SecurityAccount Number (also SSN)
Bar Codes on Specimen Tubes in the Clinical Laboratory 3.2.30 UMLS—Unified Medical Language System
CLSI LIS-8A (prior ASTM E1639) Guide for Functional 3.2.31 VHA—Veteran’s Health Administration
Requirements of Clinical Laboratory Information Man- 3.2.32 VistA—VHA Information Systems Technology Ar-
agement Systems chitecture
CLSI LIS-9A (prior ASTM E2118) Guide for Coordination
4. Significance and Use
of Clinical Laboratory Services Within the Electronic
4.1 This practice is directed at defining the application of
Health record Environment and Networked Architectures
existing conventions for the structure and content of EHR
IUPAC/IFCC Silver Book: Compendium of Terminology
systems used to support healthcare practitioners in a workplace
and Nomenclature of Properties in Clinical Laboratory
setting. In addition to supporting the capture of data on
Sciences
encounters and of periodic patient health assessments con-
IUPAC/IFCC Properties and Units in Clinical Laboratory
ducted during the time the employee is at work, this document
Sciences X Properties and Units in General Clinical
also recognizes the interaction of care rendered over a lifetime
Chemistry
and when not at work with that due to the work environment
IUPAC/IFCC Properties and Units in Clinical Laboratory
that is delivered on the work site, either for care events that
Sciences XII Properties and Units in Clinical Pharmacol-
have occupational significance or for surveillance of potential
ogy and Toxicology
health conditions that may result from the work or living
3. Terminology
environment. This document recognizes not only the privacy
3.1 Definition: and confidentiality of records that are kept in the work setting
3.1.1 case—an Occupational/Environmental Health event but also the need to be able to interchange data from the
in which one or more individuals and locations are found to workplace record with health records in other settings in order
exhibit measurements of environmental stressors that are at to fully support employee and environmental health.
variance with criteria that define normative states. 4.2 Occupational Health Programs:
3.2 Acronyms: 4.2.1 Most occupational health programs are oriented, first,
3.2.1 CAP—College of American Pathologists to any regular surveillance for observations associated with
3.2.2 CDC—Centers for Disease Control and Prevention, potentially adverse health conditions known to attend environ-
Dept. of Health and Human Services mental stressors that may be present in either the workplace or
3.2.3 CDSS—Clinical Decision Support Systems the living environment and, second, to care and documentation
3.2.4 CLIMS—Clinical Laboratory Information Manage- ofanyillnessorinjuryincurredduringtheworkdayatthework
ment System site or in other living environments. Each of these activities
3.2.5 CLSI—Clinical and Laboratory Standards Institute requires recording data for the care record that is a subset of
3.2.6 CPR—Computer-based Patient Record that regularly required for care in other more extensive
3.2.7 DHHS—Department of Health and Human Services ambulatory and inpatient care settings. It also requires relating
3.2.8 EC—Electronic Commerce the events occurring in either the work place or the living
3.2.9 EDI—Electronic Data Interchange environment to those observed healthcare data.
3.2.10 EHR—Electronic Health Record 4.2.2 This practice is intended to identify the most fre-
3.2.11 EPA—Environmental Protection Agency quently used of the general data elements which are more
3.2.12 HIN—Health Information Network completely documented in Practice E1384 and Specification
3.2.13 IDS—Integrated Delivery Systems E1633. Thus, this description constitutes a “view” of the more
3.2.14 ISA—Information Systems Architecture comprehensive set of data that might be captured in a general
3.2.15 LAS—Laboratory Automation System ambulatory care encounter. If the conventions given in this
3.2.16 LIMS—Laboratory Information Management Sys- document are adhered to, the data will ensure a record that is
tem portable to any other setting and the record will be interoper-
3.2.17 MDSS—Management Decision Support System able with other standards conformant systems, regardless of
3.2.18 MCO—Managed Care Organization their implementation techniques. Fig. 1 shows the inter-
3.2.19 MPI—Master Person/Patient Index relationships of the basic information domains that support
E2473 – 05
FIG. 1 Occupational/Environmental Health Information Subdomains
Occupational/Environmental Health programs within health- defined to be that informational record that identifies a specific
care. The Ca
...

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SIGNIFICANCE AND USE
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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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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