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ASTM E792-95e1

(Guide)

Standard Guide for Selection of a Clinical Laboratory Information Management System

Standard Guide for Selection of a Clinical Laboratory Information Management System

SCOPE
1.1 This guide covers the selection, purchase, use, enhancement, and updating of computer technology supplied by a vendor as a complete system in the clinical laboratory. The purpose of the guide is to assist hospitals, clinics, and independent laboratories through the entire automation project in order to minimize the risks and maximize the benefits. It provides a process that may be used by the medical institution to carry out laboratory information projects in a rational and orderly manner. It also includes checklists of items to be considered at each stage of planning to help guard against the unpleasant consequences of oversights. It includes planning and design aids to assist in carrying out the project. In addition, there is information (see Section 18) about enhancement and updates after the system is purchased.
Note 1—The term "stat," as used in this guide is the abbreviation for the Latin word statim, which means immediately.
1.2 This guide is not concerned with digital or computer electronics used only within instrumentation. Rather, it deals with the application of information systems to a large segment of the laboratory operation, and generally is concerned with how Information and Communications Technology (ICT) can be used to enhance the interaction of the laboratory with the rest of the institution, improve workflow in the laboratory, and help keep records. Such systems will normally include segments for patient biographical information, test ordering, specimen collection, workstations worklists, test result entry, result verification, patient result reporting, management reports, archiving, and other special functions.
1.3 The major topics are found in the following sections:  SectionProject Leader and Project Team 4Project Definition 5General5.1Self-Examination 5.2Unfulfilled Goals 5.3Alternatives 5.4Selection of Option5.5Laboratory Definition 5.6Functional Requirements 6General 6.1Admission-Discharge-Transfer6.2Test Ordering 6.3Specimen Pickup6.4Allocation6.5Test Performance 6.6Reports6.7Archival Storage 6.8Vendor Survey 7Refinement of Functional Requirements8General 8.1Priorities 8.2Preliminary Vendor Contact 8.3Site Visit 8.4Approvals 9Requests for Proposals10Evaluation of Vendor Proposals 11General 11.1Evaluation of Cost 11.2Warranty 11.3Maintenance 11.4Hardware 11.5Software 11.6Backup System 11.7Interfaces 11.8Training 11.9Acceptance11.10Evaluation of Vendors 11.11Selection of Vendor 12Purchase 13Installation 14Site preparation 14.1Delivery 14.2Installation 14.3Startup 14.4Training15Acceptance 16Records and Evaluations 17General17.1Documentation of Normal Operations17.2Documentation of Maintenance17.3Evaluation of System Performance17.4Enhancements and Updating 18
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

General Information

Status
Historical
Publication Date
09-Jan-2002
ICS
35.240.80 - IT applications in health care technology
Technical Committee
E31 - Healthcare Informatics
Current Stage
Ref Project

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ASTM E792-95e1 - Standard Guide for Selection of a Clinical Laboratory Information Management SystemASTM E792-95e1 - Standard Guide for Selection of a Clinical Laboratory Information Management System
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ASTM E792-95e1 - Standard Guide for Selection of a Clinical Laboratory Information Management System
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NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
e1
Designation: E 792 – 95 An American National Standard
Standard Guide for
Selection of a Clinical Laboratory Information Management
System
This standard is issued under the fixed designation E 792; 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.
e NOTE—Specification E 1633 was added editorially to 2.1 and 6.2.2 upon its approval.
1. Scope
Self-Examination 5.2
Unfulfilled Goals 5.3
1.1 This guide covers the selection, purchase, use, enhance-
Alternatives 5.4
ment, and updating of computer technology supplied by a
Selection of Option 5.5
Laboratory Definition 5.6
vendor as a complete system in the clinical laboratory. The
Functional Requirements 6
purpose of the guide is to assist hospitals, clinics, and inde-
General 6.1
pendent laboratories through the entire automation project in
Admission-Discharge-Transfer 6.2
Test Ordering 6.3
order to minimize the risks and maximize the benefits. It
Specimen Pickup 6.4
provides a plan-of-attack that may be used by the medical
Allocation 6.5
institution to carry out computer automation projects in a Test Performance 6.6
Reports 6.7
rational and orderly manner. It also includes checklists of items
Archival Storage 6.8
to be considered at each stage of planning to help guard against
Vendor Survey 7
the unpleasant consequences of oversights. It includes planning Refinement of Functional Requirements 8
General 8.1
and design aids to assist in carrying out the project. In addition,
Priorities 8.2
there is information (see Section 18) about enhancement and
Preliminary Vendor Contact 8.3
updates after the system is purchased. Site Visit 8.4
Approvals 9
NOTE 1—The term “stat,” as used in this guide is the abbreviation for
Requests for Proposals 10
Evaluation of Vendor Proposals 11
the Latin word statim, which means immediately.
General 11.1
1.2 This guide is not concerned with digital or computer
Evaluation of Cost 11.2
Warranty 11.3
electronics used only within instrumentation. Rather, it deals
Maintenance 11.4
with the application of computers to a large segment of the
Hardware 11.5
laboratory operation, and generally is concerned with how
Software 11.6
Backup System 11.7
computer technology can be used to enhance the interaction of
Interfaces 11.8
the laboratory with the rest of the institution, improve work-
Training 11.9
flow in the laboratory, and help keep records. Such systems
Acceptance 11.10
Evaluation of Vendors 11.11
will normally include segments for patient biographical infor-
Selection of Vendor 12
mation, test ordering, specimen collection, workstations
Purchase 13
worklists, test result entry, result verification, patient result
Installation 14
Site preparation 14.1
reporting, management reports, archiving, and other special
Delivery 14.2
functions.
Installation 14.3
1.3 The major topics are found in the following sections:
Start-up 14.4
Training 15
Section
Acceptance 16
Project Leader and Project Team 4
Records and Evaluations 17
Project Definition 5
General 17.1
General 5.1
Documentation of Normal Operations 17.2
Documentation of Maintenance 17.3
Evaluation of System Performance 17.4
Enhancements and Updating 18
This guide is under the jurisdiction of ASTM Committee E-31 on Healthcare
Informatics and is the direct responsibility of Subcommittee E31.13on Clinical 1.4 This standard does not purport to address all of the
Laboratory Systems. This guide was prepared in cooperation with the College of
safety concerns, if any, associated with its use. It is the
American Pathologists.
Current edition approved Jan. 15, 1995. Published March 1995. Originally
published as E 792 – 81. Last previous edition E 792 – 94.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
E 792
responsibility of the user of this standard to establish appro- ANS/IEEE 983-85 Software Quality Assurance Plans Guide
priate safety and health practices and determine the applica-
ANS/IEEE 1002-87 Taxonomy for Software Engineering
bility of regulatory limitations prior to use.
Standards
ANS/IEEE 1008-86 Software Unit Testing
2. Referenced Documents
ANS/IEEE 1012-86 Software Verification and Validation
2.1 ASTM Standards:
Plans
E 622 Guide for Developing Computerized Systems
ANS/IEEE 1016-87 Software Design Descriptions
E 623 Guide for Developing Functional Requirements for
ANS/IEEE 1058.1-87 Software Project Management Plans
Computerized Systems
ANS/IEEE 1063-87 Software User Documentation
E 624 Guide for Developing Implementation Designs for
ANS/IEEE 1074-8x Software Life Cycle Processes
Computerized Systems
IEEE EMBS Standards
E 625 Guide for Training Users of Computerized Systems
2.3 ISO Information Systems Engineering Standards:
E 626 Guide for Evaluating Computerized Systems
ISO 6592 Information Processing—Guidelines for the
E 627 Guide for Documenting Computerized Systems
Documentation of Computer-Based Application Systems
E 730 Guide for Developing Functional Designs for Com-
ISO 9127 Information Processing—User Documentation
puterized Systems
and Cover Information for Consumer Software Packages
E 731 Guide for Selection and Acquisition of Commercially
2 ISO 9294 Information Processing—Guidelines for the Man-
Available Computerized Systems
agement of Software Documentation
E 919 Specification for Software Documentation for a
2 2.4 Other ISO Information Systems Related Standards:
Computerized System
HL-7, Health Industry Level Interface Standards, v 2.2
E 1013 Terminology Relating to Computerized Systems
2.5 ANSI Standards:
E 1029 Guide for Documentation of Clinical Laboratory
ANS X3.88-1981 Computer Program Abstracts
Computer Systems
ANS X3.172-1990 Dictionary for Information Systems
E 1113 Guide for Project Definition for Computerized Sys-
tems ANS X3-TR-6-82 Guide for Technical Documentation of
E 1238 Specification for Transferring Clinical Observations Computer Projects
Between Independent Computer Systems
ANS X3-TR-89 Documentation of Consumer Software
E 1239 Guide for Description for Reservation/ Packages
Registration—Admission, Discharge, Transfer (R-ADT)
ANS X11.1 The MUMPS Programming Language
Systems for Automated Patient Care Information Systems
2.6 Federal and DoD Standards:
E 1246 Practice for Reporting Reliability of Clinical Labo-
FIPSPUB 38-76 Documentation of Computer Programs and
ratory Computer Systems
Automated Data Systems
E 1381 Specification for Low-Level Protocol to Transfer
FIPSPUB 120-87 The MUMPS Programming Language
Messages Between Clinical Laboratory Instruments and
FIPSPUB 64-79 Documentation of Computer Programs
Computer Systems
and Automated Data Systems for the Initiation Phase
E 1384 Guide for Description for Content and Structure of
DoD Stand 7935 Documentation of Computer Programs
an Automated Primary Record of Care
and Automated Data Systems
E 1394 Specification for Transferring Information Between
DoD Std 2167A Defense System Software Development
Clinical Instruments and Computer Systems
DoD Std 2168 Software Quality Assurance Requirements
E 1466 Specification for the Use of Bar Codes on Specimen
2.7 NIST Standard:
Tubes in the Clinical Laboratory
NBS Handbook 118 The MUMPS Programming Language
E 1633 Specification for Coded Values Used in the
Computed-Based Patient Record
3. Significance and Use
2.2 IEEE Standards:
3.1 The decision to computerize a clinical laboratory is an
2.2.1 IEEE Computer Society Standards:
extremely critical one, and needs to be approached with utmost
ANS/IEEE 610.2-87 Computer Application Terminology
care. There are numerous examples where such attempts have
ANS/IEEE 610.12 Glossary of Software Engineering Ter-
met with financial and operational failure, as well as many
minology
successful projects that have improved laboratory and hospital
ANS/IEEE 730-84 Software Quality Assurance Plans
operation. A key factor in most of the failures is poor planning
ANS/IEEE 828-83 Software Configuration Management
or bad administrative design decisions at some point in the
Plans
ANS/IEEE 829-83 Software Test Documentation
ANS/IEEE 830-84 Software Requirements Specification
Available from American National Standards Institute, 11 W. 42nd St., 13th
Floor, New York, NY 10036.
Available from Health Level Seven, 900 Victors Way, Suite 122, Ann Arbor, MI
Annual Book of ASTM Standards, Vol 14.01. 48108.
3 7
Discontinued. See 1994 Annual Book of ASTM Standards, Vol 14.01. Available from Standardization Documents Order Desk, Bldg. 4 Section D, 700
Available from The Institute of Electrical and Electronics Engineers, Inc., 345 Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPODS.
E. 47th St., New York, NY 10017. Available from NIST, Gaithersburg, MD 20899.
E 792
project. There are many far-reaching manifestations of auto- 4.3 The individual should be of sufficient status within the
mation that are not always fully appreciated at the early stages institution to allow effective communication with management,
of the project when key decisions are required. physicians, and others concerned with the project. The project
3.2 This is not a purchase guide. It is a description of the leader needs the cooperation of key individuals and must be
procedures a hospital laboratory should follow to most likely capable of working effectively with them. They include the
result in a productive and viable computer system that meets administrative board, the chief executive officer, the budget
the needs of the laboratory. It contains sections that may not be officer, the head of the laboratory, the head of data processing,
appropriate in all settings, and users of this guide must decide the head of the planning office, and the main users, the head of
what is important and what is not. the medical staff and the head of nursing. Since the computer
3.3 In any such project, there is obviously a technical project usually affects a wide segment of the institution, and is
component. Appropriate hardware and software must be in- sometimes disruptive of established routines, the project leader
stalled to provide necessary communications, database storage, must have the strong support of (1) someone high in the overall
processing activities, and report printing functions. There is hospital management; and (2) the laboratory director. Without
usually also a need for a strong “human orientation” that this support, the project is likely to be unsuccessful for the
includes meaningful input protocols and easily understood simple reason that necessary cooperation from the various
output displays. Besides the system’s technical considerations, segments of the hospital will not be forthcoming.
there is an organizational component to be examined. Those
4.4 If a person is recruited from outside the institution, it
changes that will be necessary in the traditional procedures
should be on a permanent and not temporary basis. The
within the laboratory or the rest of the institution should be
position in the organization and responsibility to the institution
considered during the planning of the project.
should be clearly established. If an existing member of the
3.4 The importance of getting input into the planning from
institution’s staff is selected, adequate allowance for the time
all concerned parties is stressed in this guide. These include the
demands of the project must be made. In either case, the project
institution administrators, laboratory management, laboratory
leader should report to an individual supportive of the project
staff, physicians, nurses, other laboratory customers, and com-
and high enough in the power structure to ensure cooperation
puter system vendors. Also stressed is the importance of
and support from impacted hospital units. A chain of command
thorough program review, consideration of alternatives, and
with an excessive number of links between the project leader
careful definition of expectations before a decision to utilize
and the higher management levels is unsatisfactory.
computer technology is made. Computer systems should be
4.5 The project leader should have sufficient authority to
installed in response to an operational need, not for other
call meetings, make operational and procedural decisions
reasons like institutional prestige or the necessity to use up
concerning the project, and commit planning funds.
available funds. Finally, this guide will prescribe very thorough
4.6 If the individual chosen is not well-versed in computers,
planning and documentation of criteria prior to commitment to
he or she must acquire some of that knowledge. It is important
a particular system. All too often, the decision to use the
that the project leader, while not necessarily an expert in all the
product of a particular vendor is made before the requirements
areas of specialization needed for the project, be able to
of the project are fully understood.
communicate with individuals in both the computer technology
field and the medical field.
4. Project Leader and Project Team
4.7 It is also important that a proper team be selected to
4.1 The project leader should be chosen early in the project
carry out the automation project. This team should be config-
with care since success of the project depends in large part on
ured to give representation to all concerned parties. These
this individual. It is best if the project leader is based in the
include the users of the laboratory services (test requestors,
laboratory as opposed to other hospital units. The leader must
readers of reports, etc); the laboratory personnel that perform
be well-motivated and respected by the hospital staff. This
the services; the hospital admission-discharge-transfer (ADT)
usually means the individual should be a member of the senior
and billing personnel; the hospital computer center, and the
medical staff of the clinical laboratory, or at least someone with
hospital management. The project leader may elect to include
good rapport with that staff. If not a physician, the individual
assistance from individuals with specific proven expertise from
must have sufficient knowledge of medicine and hospital
the institution.
procedure to converse with the medical staff.
4.8 It is possible for a project team to become so large and
4.2 A good candidate for the project leader is the director of
unwieldly that little can be accomplished. A core team may be
clinical laboratories, provided the individual has sufficient
selected to carry out most of the work turning to the entire body
knowledge of computers a
...

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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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