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ASTM E1744-98

(Guide)

Standard Guide for View of Emergency Medical Care in the Computer-Based Patient Record

Standard Guide for View of Emergency Medical Care in the Computer-Based Patient Record

SCOPE
1.1 This guide covers the identification of the information that is necessary to document emergency medical care in a computerized patient record that is part of a paperless patient record system. The intent of a paperless patient record system will be to improve efficiency and cost-effectiveness.  
1.2 This guide is a view of the data elements to document the types of emergency medical information that would be valuable if available in the computerized patient record.  
1.2.1 The patient's summary record and derived data sets will be described separately from this guide.  
1.2.2 As a view of the computerized patient record, the information presented will conform to the structure defined in other ASTM standards for the computerized patient record.  
1.3 This guide is intended to amplify Guides E1239, E1384, and F1629 and the formalisms described in Practice E1715.  
1.3.1 This guide details the use of data elements already established in these standards for use during documentation of emergency care in the field or in a treatment facility and places them in the context of the object models for health care that will be the vehicle for communication standards for health care data.  
1.3.1.1 The codes for the data elements referred to in this guide will be developed in consideration of national or professional guidelines whenever available. The EMS definitions are based on those generated from the national consensus conference sponsored by NHTSA and from ASTM F30.03.03 on EMS Management Information Systems. The Emergency Department (ED) definitions will consider those recommended by the CDC workshop on ED definitions scheduled for January 1996. The hospital discharge definitions will be developed in consideration of existing requirements for Medicare and Medicaid payment.  
1.3.1.2 The ASTM process allows for the definitions to be updated as the national consensus changes. When national or professional definitions do not exist, or whenever there is a conflict in the definitions, the committee will recommend a process for resolving the conflict or present the various definitions within the document along with an explanation for the purpose of each definition.  
1.3.2 This guide reinforces the concepts set forth in Guides E1239 and E1384 that documentation of care in all settings shall be seamless and be conducted under a common set of precepts using a common logical record structure and common terminology.  
1.4 The computerized patient record focuses on the patient.  
1.4.1 In particular, the computerized patient record sets out to ensure that the data document includes:  
1.4.1.1 The occurrence of the emergency,  
1.4.1.2 The symptoms requiring emergency medical treatment,  
1.4.1.3 The medical/mental assessment/diagnoses established,  
1.4.1.4 The treatment rendered, and  
1.4.1.5 The outcome and disposition of the patient after emergency treatment.  
1.4.2 The computerized patient record consists of subsets of the data computerized by multiple care providers at the time of onset/scene and enroute, in the emergency department, and in the hospital or other emergency health care settings.  
1.4.3 The computerized patient record focuses on the documentation of information that is necessary to support patient care but does not define appropriate care.

General Information

Status
Historical
Publication Date
02-Nov-1997
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 E1744-04 - Standard Practice for View of Emergency Medical Care in the Electronic Health Record
Effective Date
01-Nov-2004

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ASTM E1744-98 - Standard Guide for View of Emergency Medical Care in the Computer-Based Patient RecordASTM E1744-98 - Standard Guide for View of Emergency Medical Care in the Computer-Based Patient Record
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ASTM E1744-98 - Standard Guide for View of Emergency Medical Care in the Computer-Based Patient 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:E1744–98
Standard Guide for
View of Emergency Medical Care in the Computer–Based
Patient Record
This standard is issued under the fixed designation E 1744; 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 1.3.1.4 The hospital discharge definitions are based on
recommendations from the Health Care FinancingAdministra-
1.1 This guide covers the identification of the information
tion for Medicare and Medicaid payment and from the Depart-
that is necessary to document emergency medical care in a
ment of Health and Human Services for the Uniform Hospital
computerized, paperless patient record system that is designed
Discharge Data Set.
to improve efficiency and cost-effectiveness.
1.3.1.5 Because the current trend is to store data as text, the
1.2 This guide is a view of the data elements to document
codes for the attribute values have been determined as unnec-
the types of emergency medical information that should be
essary and thus are eliminated from this document.
included in the computer–based patient record.
1.3.1.6 The ASTM process allows for the data elements to
1.2.1 The patient’s summary record and derived data sets
be updated as the national consensus changes. When national
will be described separately from this guide.
or professional guides do not exist, or whenever there is a
1.2.2 As a view of the computer-based patient record, the
conflict in the existing EMS, ED, hospital or other guides, the
information presented will conform to the structure defined in
committee will recommend a process for resolving the conflict
other ASTM standards for the computer-based patient record.
or an explanation of the conflict within each guide.
1.3 This guide is intended to amplify Guides E 1239,
1.3.2 This guide reinforces the concepts set forth in Guides
E 1384, and F 1629 and the formalisms described in Practice
E 1239 and E 1384 that documentation of care in all settings
E 1715.
shall be seamless and be conducted under a common set of
1.3.1 This guide details the use of data elements already
precepts using a common logical record structure and common
established in these standards and other national guidelines for
terminology.
use during documentation of emergency care in the field or in
1.4 The computer–based patient record focuses on the
a treatment facility and places them in the context of the object
patient.
models for health care in Guide E 1384 that will be the vehicle
1.4.1 In particular, the computer–based patient record sets
for communication standards for health care data.
out to ensure that the data document includes:
1.3.1.1 The data elements and the attributes referred to in
1.4.1.1 The occurrence of the emergency,
this guide are based on national guidelines whenever available.
1.4.1.2 The symptoms requiring emergency medical treat-
1.3.1.2 The EMS definitions are based on those generated
ment, and potential complications resulting from preexisting
fromtheEMSconsensusconferencesponsoredbyNHTSAand
conditions,
from ASTM task group F 30.03.03 on EMS Management
1.4.1.3 The medical/mental assessment/diagnoses estab-
Information Systems.
lished,
1.3.1.3 The Emergency Department (ED) definitions are
1.4.1.4 The treatment rendered, and
based on the Data Elements for Emergency Department Sys-
1.4.1.5 The outcome and disposition of the patient after
tems (DEEDS) distributed by the Centers for Disease Control
emergency treatment.
in June 1997.
1.4.2 The computer–based patient record consists of subsets
of data for the emergency patient that have been computerized
This guide is under the jurisdiction of ASTM Committee E-31 on Healthcare by different care providers at the time of treatment at the scene
Informatics and is the direct responsibility of Subcommittee E31.19 on Electronic
and en route, in the emergency department, and in the hospital
Health Record Content and Structure.
or other emergency health care settings.
Current edition approved July 10, 1998. Published March 1999. Originally
published as E 1744–95. Last previous edition E 1744–95.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
E1744–98
1.4.3 The computer–based patient record focuses on the 3.1.4 emergency episode—a series of encounters relating to
documentation of information that is necessary to support an emergency condition that may lead either to death, full
patient care but does not define appropriate care. recovery, or a clinical steady state.
3.1.5 emergency episode documentation—those recorded
2. Referenced Documents observations that describe the care rendered during the period
of an emergency episode, whether brief or extended.
2.1 ASTM Standards:
3.1.6 other emergency outpatient facility—emergency facil-
E 1239 Guide for Description of Reservation/Registration-
itythatisnotalicensedemergencydepartmentconnectedtoan
Admission, Discharge, Transfer (RADT) Systems for Au-
acute care hospital but which provides emergency stabilization
tomated Patient Care Information Systems
and treatment upon demand. Such facilities may include
E 1384 Guide for Description of Content and Structure of
clinic/health centers, freestanding ambulatory surgery center,
an Automated Primary Record of Care
physician’s office, etc.
E 1633 Specification for Coded Values Used in the
3.1.7 pre-hospital EMS data set—that set of data elements
Computer-Based Patient Record
collected at onset and en route prior to arrival at the first
E 1715 Practice for an Object-Oriented Model for Registra-
treatment facility.
tion,Admitting,DischargeandTransfer(RADT)Functions
in Computer-Based Patient Record Systems
4. Significance and Use
E 1869 Guide for Confidentiality, Privacy,Access and Data
Security Principles for Health Information Including
4.1 The Emergency Medical Service System (EMSS) in the
Computer-Based Patient Records
United States has largely arisen since 1945 and has drawn to a
E 1985 Guide for User Authentication and Authorization
great degree from the experience gained in military conflicts
F 1177 Terminology Relating to Emergency Medical Ser-
during and since World War II. The documentation of care,
vices
however, has remained largely paper record–based until re-
F 1288 Guide for Planning for and Response to a Multiple
cently.
Casualty Incident
4.1.1 Beginning in the 1970s both civilian and military
F 1629 Guide for Establishing and/or Operating Emergency
agencies have closely examined electronic means of storing
Medical Services Management Information Systems
and managing patient data about emergency medical care.
PS 100 Provisional Specification for Authentication of
4.1.2 The report of the Institute of Medicine on the
Healthcare Information Using Digital Signatures
Computer-Based Patient Record has emphasized the use of
2.2 ANSI Standard:
information technology in patient care in general and emer-
X3.172 American National Dictionary for Information Sys-
gency care data in particular.
tems 1990
4.1.3 During this period ASTM has documented the logical
2.3 Institute of Electrical Electronic Engineers Standards:
structure of the computer-based patient record in Guides
610.2 Standard Glossary of Computer Applications Termi-
E 1239andE 1384,whileGuideF 1629hasdefinedthepatient
nology
care data, to be gathered in the pre-hospital record, and the
610.5 Standard Glossary of Data Management Terminol-
outcome data, relative to the pre-hospital phase of the emer-
ogy
gency, which are collected in the emergency department and
729 Standard Glossary of Software Engineering Terminol-
after inpatient admission.
ogy
4.1.3.1 Specifications for the logic model are also presented
in Practice E 1715.
3. Terminology
4.2 This guide shows how the data gathered for EMS
operations and management merge smoothly into the
3.1 Definitions of Terms Specific to This Standard:
computer-based patient record, consistent with the recognition
3.1.1 emergency condition—change(s) in the patient’s
that these data are part of the primary record of care. Several
health status perceived to require immediate medical attention
states have formalized that recognition in state law.
to prevent unnecessary death or disability.
4.2.1 This guide does not instruct physicians how to collect
3.1.2 emergency department (ED) data set—that set of data
data for patient care.
elements collected in the emergency outpatient treatment
4.2.2 This guide does not indicate what information needs
facility prior to admission as an inpatient.
to be collected at the time of patient care.
3.1.3 emergency encounter—a single event of health care
4.3 The task now is to document, using standard conven-
foranemergency,suchascareatthescene,orattheemergency
tions, the means by which this integration occurs in order to set
outpatientsetting.Itconcludeswhenthepatientproceedstothe
the stage for the capture and transfer of such emergency care
next phase of care for the emergency.
data using information technology and telecommunications in
a standardized way consistent with all other settings of care
while protecting the privacy and confidentiality of that data.
Annual Book of ASTM Standards, Vol 14.01.
Annual Book of ASTM Standards, Vol 13.01.
Available from American National Standards Institute, 11 W. 42nd St., 13th
Floor, New York, NY 10036.
5 6
Available from IEEE, 445 Hoes Lane, P.O. Box 1331, Piscataway, NJ State of Washington: Revised Code of Washington 76.168 and Washington
08855–1331. Administrative Code 246-976-380.
E1744–98
4.3.1 The computer–based patient record has the potential 5.1.1 Fig. 1 presents the different phases of emergency from
toreducehealthcarecostsbyoptimizingcasemanagementand onset until final disposition, at which point the patient is no
supporting effective post ED follow-up. longer the responsibility of emergency care.
4.3.2 Systematizing the data also enhances its ability to be
5.1.2 In some instances, emergency patients are transported
used consistently, with proper protection, for research into and
from the location of onset to an emergency department and
for management of EMSS operations within the various
thenlatertransferredtospecialtytertiarycarecenterstoreceive
jurisdictional boundaries.
treatment for life-threatening medical problems.
4.4 The computer–based form of the emergency episode
5.1.3 Records completed for the emergency patient at dif-
documentation utilizes the same logical data model as the
ferent points in time are unique to the type of emergency
computer–based patient record, but it focuses on data collected
response and the phase of the emergency.
during the different phases of the emergency.
5.1.4 This guide does not include rehabilitation and outpa-
4.4.1 These data sets do not limit what may be recorded, or
tient follow-up as part of emergency medical care since this
by whom, but they do identify those data considered essential,
information is recorded elsewhere in the CPR and is not within
when they exist.These data sets include all those data recorded
the scope of this guide.
to document instances of emergency medical care.
5.2 Documentation of emergency care is more efficient if
4.4.2 Data organized to enhance flexible and efficient man-
the data are computerized at the time of collection so that this
agement of information.
information can be incorporated simultaneously into the com-
4.4.2.1 Identifications of practitioners and facilities will be
puter–based patient record at the time of data entry.
coded, when necessary, to protect confidentiality and to make
5.3 A core of patient identification information (age/date of
provider data comparable. Names will be included when they
birth, sex/gender, facility identification, times, etc.) is common
are necessary to support patient care.
to all of the medical records.
4.4.2.2 Provider identification numbers will be maintained
5.3.1 Other data elements exist that are unique to the
on master data files which also include additional information
emergency event, and still others exist that are unique to a
such as specialty, license level, and the like.
specific care site.
4.4.2.3 Provider identification numbers recorded on the
5.3.2 Although many different records may be completed
computer–based patient record will automatically link to the
for a single emergency patient, not all of the data collected are
master data files to eliminate the need for duplicate data entry
incorporated into the computer-based patient record.
of reference material in the patient record.
5.3.2.1 Except for times (see 6.14.4 and 6.14.14), adminis-
4.4.2.4 Coding systems for emergency reporting (ICD-9-
7 8 9
CM, CPT, HCPCS, SNOMED ) will be referenced in the trative data which are useful for ambulance service manage-
ment information, such as the use of lights and sirens and
master data files for Guide E 1384 as appropriate.
4.4.2.5 The efficient arrangement of the logical model mileage, the EMS agency’s response number, the type of EMS
vehicle, and environmental factors affecting EMS care, have
Guide E 1384 permits output to be generated and identified to
mirror the paper record, such as nurse-specific or physician- been excluded from the computer–based patient record, which
specific notes. focuses on the patient.
4.4.2.6 The arrangement of the logical model permits mul-
5.4 The computer–based patient record has the potential to
tiple entries of assessment data, using a small group of
improve data quality as follows.
variables, that can then be used to generate output. For
5.4.1 Time and date entries will not be subject to the
example, sequence of diagnoses by date-time.
idiosyncrasies of the clock at hand, or the memory of the
person entering the data but may be automatically recorded by
5. Phases of Emergency Medical Care
the computer; however, when data are entered retrospectively,
5.1 Patient data are collected during the different phases of
the system should allow a manual override to record actual
theemergencybydifferentcareproviders,thenumberandtype
time.
depend on the severity of the emergency.
5.4.2 Direct data entry, by voice, dictation, touch, etc., by
the care provider will eliminate the need to interpret the care
Current Procedure Terminology for Physician Services.
provider’s handwriting.
HCFA (Health Care Financing Administration) Common Procedure Coding
5.5 Each segment of emergency care is cumulative, though
System.
Systematized Nomenclature of Medicine.
not necessarily sequential, to the prior docum
...

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5.1 Personnel that are responsible for the creation, transfer, and storage of digital X-ray test results will use this standard. This practice defines a set of information modules that, along with Practice E2339 and the DICOM standard, provides a standard means to organize digital X-ray test parameters and results. The digital X-ray test results may be displayed and analyzed on any device that conforms to this standard. Personnel wishing to view any digital X-ray inspection data stored according to Practice E2339 may use this document to help them decode and display the data contained in the DICONDE-compliant inspection record.
SCOPE
1.1 This practice covers the interoperability of digital X-ray imaging equipment using Digital Detector Arrays (DDA) as described in Practice E2698 by specifying image data transfer and archival methods in commonly accepted terms. A separate practice, Practice E2738, addresses this topic for digital X-ray imaging equipment using Computed Radiography (CR). This document is intended to be used in conjunction with Practice E2339 on Digital Imaging and Communication in Nondestructive Evaluation (DICONDE). Practice E2339 defines an industrial adaptation of DICOM NEMA PS3 / ISO 12052 (DICOM, see http://medical.nema.org), an international standard for image data acquisition, review, storage, and archival storage. The goal of Practice E2339, commonly referred to as DICONDE, is to provide a standard that facilitates the display and analysis of NDE results on any system conforming to the DICONDE standard. Toward that end, Practice E2339 provides a data dictionary and a set of information modules that are applicable to all NDE modalities. This practice supplements Practice E2339 by providing information object definitions, information modules, and a data dictionary that are specific to digital X-ray test methods.  
1.2 This practice has been developed to overcome the issues that arise when analyzing or archiving data from digital X-ray test equipment using proprietary data transfer and storage methods. As digital technologies evolve, data must remain decipherable through the use of open, industry-wide methods for data transfer and archival storage. This practice defines a method where all the digital X-ray technique parameters and test results are communicated and stored in a standard manner regardless of changes in digital technology.  
1.3 This practice does not specify:  
1.3.1 A testing or validation procedure to assess an implementation's conformance to the standard.  
1.3.2 The implementation details of any features of the standard on a device claiming conformance.  
1.3.3 The overall set of features and functions to be expected from a system implemented by integrating a group of devices each claiming DICONDE conformance.  
1.4 Units—Although this practice contains no values that require units, it does describe methods to store and communicate data that do require units to be properly interpreted. The SI units required by this practice are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM
ASTM 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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