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ASTM E1578-93(1999)

(Guide)

Standard Guide for Laboratory Information Management Systems (LIMS)

Standard Guide for Laboratory Information Management Systems (LIMS)

SCOPE
1.1 This guide describes computer systems used to manage laboratory information. The term Laboratory Information Management Systems (LIMS) describes this class of computer systems.  
1.2 This guide covers LIMS ranging from small laboratories with simple requirements to large multi-site laboratories with complex requirements. The elements of the LIMS guide may be selected based on specific laboratory requirements.  
1.3 The audience of this document includes: (1) end users of LIMS, (2) implementers of LIMS, (3) LIMS vendors, (4) instrument vendors, and (5) individuals who must approve LIMS funding.  
1.4 The purpose of this guide includes: (1) help educate new users of Laboratory Information Management Systems (LIMS), (2) provide standard terminology that can be used by LIMS vendors and end users, (3) establish minimum requirements for primary LIMS functions, (4) provide guidance for the specification, evaluation, cost justification, implementation, project management, training, and documentation, and (5) provide an example of a LIMS function checklist.  
1.5 Information contained in this guide will benefit a broad audience of people who work or interact with a laboratory. New LIMS users can use this guide to understand the purpose and functions of LIMS. The guide can help prospective LIMS users in understanding terminology, configurations, features, design, and costs. Individuals who are purchasing a LIMS can use this guide to identify functions that are recommended for specific laboratory environments. LIMS vendor Research and Development staffs can use the guide as a tool to evaluate, identify, and correct areas that need improvement. LIMS vendor sales staffs can use the guide to accurately represent functions of their LIMS product to prospective customers. This guide does not define laboratory instrument interfaces.  
1.6 This guide can be used by laboratories of all sizes. The guide addresses complex issues that impact primarily large LIMS implementations. Small laboratories should review issues that may impact their environments. The implementation times and recommendations listed in this guide are directed at medium and large laboratories.

General Information

Status
Historical
Publication Date
09-Aug-1999
ICS
35.240.80 - IT applications in health care technology
Technical Committee
E13 - Molecular Spectroscopy and Separation Science
Drafting Committee
E13.15 - Analytical Data
Current Stage
Ref Project

Relations

Replaced By
ASTM E1578-06 - Standard Guide for Laboratory Information Management Systems (LIMS)
Effective Date
01-Sep-2006
Referred By
ASTM C1009-21 - Standard Guide for Establishing and Maintaining a Quality Assurance Program for Analytical Laboratories Within the Nuclear Industry
Effective Date
10-Aug-1999

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ASTM E1578-93(1999) - Standard Guide for Laboratory Information Management Systems (LIMS)ASTM E1578-93(1999) - Standard Guide for Laboratory Information Management Systems (LIMS)
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ASTM E1578-93(1999) - Standard Guide for Laboratory Information Management Systems (LIMS)
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:E1578–93(Reapproved1999)
Standard Guide for
Laboratory Information Management Systems (LIMS)
This standard is issued under the fixed designation E 1578; 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 times and recommendations listed in this guide are directed at
medium and large laboratories.
1.1 This guide describes computer systems used to manage
laboratoryinformation.ThetermLaboratoryInformationMan-
2. Referenced Documents
agement Systems (LIMS) describes this class of computer
2.1 ASTM Standards:
systems.
E 622 Generic Guide for Computerized Systems
1.2 ThisguidecoversLIMSrangingfromsmalllaboratories
E 625 Guide for Training Users of Computerized Systems
with simple requirements to large multi-site laboratories with
E 627 Guide for Documenting Computerized Systems
complex requirements. The elements of the LIMS guide may
E 730 Guide for Developing Functional Designs for Com-
be selected based on specific laboratory requirements.
puterized Systems
1.3 Theaudienceofthisdocumentincludes:(1)endusersof
E 731 GuideforSelectionandAcquisitionofCommercially
LIMS, (2) implementers of LIMS, (3) LIMS vendors, (4)
Available Computerized Systems
instrument vendors, and (5) individuals who must approve
E 792 Guide for Computer Automation in the Clinical
LIMS funding.
Laboratory
1.4 The purpose of this guide includes: ( 1) help educate
E 919 Specification for Software Documentation for a
new users of Laboratory Information Management Systems
Computerized System
(LIMS), (2) provide standard terminology that can be used by
E 1013 Terminology Relating to Computerized Systems
LIMS vendors and end users, (3) establish minimum require-
E 1029 Guide for Documentation of Clinical Laboratory
ments for primary LIMS functions, (4) provide guidance for
Computer Systems
thespecification,evaluation,costjustification,implementation,
E 1340 Guide for Rapid Prototyping of Computerized Sys-
project management, training, and documentation, and (5)
tems
provide an example of a LIMS function checklist.
E 1381 Specification for Low-Level Protocol to Transfer
1.5 Information contained in this guide will benefit a broad
Messages Between Clinical Laboratory Instruments and
audience of people who work or interact with a laboratory.
Computer Systems
New LIMS users can use this guide to understand the purpose
E 1394 Specification for Transferring Information Between
and functions of LIMS. The guide can help prospective LIMS
Clinical Instruments and Computer Systems
users in understanding terminology, configurations, features,
2.2 IEEE Standards:
design, and costs. Individuals who are purchasing a LIMS can
100—Standard Dictionary of Electrical and Electronic
use this guide to identify functions that are recommended for
Terms
specific laboratory environments. LIMS vendor Research and
610—Standard Glossaries of Computer-Related Terminol-
Development staffs can use the guide as a tool to evaluate,
ogy
identify, and correct areas that need improvement. LIMS
729—Glossary of Software Engineering Terminology
vendor sales staffs can use the guide to accurately represent
730.1—Standard for Software Quality Assurance Plans
functions of their LIMS product to prospective customers.This
730.2—Guide for Software Quality Assurance Plans
guide does not define laboratory instrument interfaces.
828—Standard for Software Configuration Management
1.6 This guide can be used by laboratories of all sizes. The
Plans
guide addresses complex issues that impact primarily large
829—Standard for Software Test Documentation
LIMS implementations. Small laboratories should review is-
830—Guide to Software Requirements Specifications
sues that may impact their environments. The implementation
1008—Standard for Software Unit Testing
This guide is under the jurisdiction of ASTM Committee E13 on Molecular
Spectroscopy and Chromatography and is the direct responsibility of Subcommittee Annual Book of ASTM Standards, Vol 14.01.
E13.15 on Analytical Data. Available from IEEE, 445 Hoes Lane, P.O. Box 1331, Piscataway, NJ
Current edition approved Oct. 15, 1993. Published December 1993. 08855-1331.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
E1578–93 (1999)
1012—Standard for Software Verification and Validation 3.3.4 data, n—record observations used for producing in-
Plans formation.
1016—Recommended Practice for Software Design De-
3.3.5 data analysis, n—the ability to display, manipulate,
scriptions transform, and verify LIMS database information.
1028—Standard for Software Reviews and Audits
3.3.6 data/information capture, v—the uni/bi-directional
1042—Guide to Software Configuration Management
communication of data/information to/from a LIMS.
1058.1—Standard for Software Project Management Plans
3.3.7 data integrity, n—the concept that information is not
1063—Standard for Software User Documentation
corrupted during communication, transfer, manipulation, stor-
1074—Standard for Developing Software Life Cycle Pro-
age, and recall functions.
cesses
3.3.8 determination, n—a single result, the lowest level of
1228—Standard for Software Safety Plans
information in a LIMS.
2.3 ANSI Standards:
3.3.8.1 Discussion—ALIMS example of a determination is
X3.172 American National Dictionary for Information Pro-
a pH result.
cessing Systems (ANDIS)
3.3.9 dynamictable(s),n—LIMSdatabasetable(s)orfile(s)
X3.135 Standard for Structured Query Language (SQL-2)
where sample and result information are stored.
X3.168 Standard for Embedding Structured Query Lan-
3.3.9.1 Discussion—The storage of LIMS sample and result
guage in Three GL Programs
data/information can be in one or more database tables.
2.4 ISO Standards:
Synonyms: LIMS database, active database.
InternationalStandardsOrganization(ISO)9000 Standards
3.3.10 event-triggering, v— action(s) performed following
2.5 Other Standards:
a specific condition(s).
Data Communication Standard for Chromatography
3.3.10.1 Discussion—Event triggering conditions can be
Data Communication Standard for Mass Spectrometry
initiated by way of data, process, or other external events.
CAALS-I Communication Specification
3.3.11 information, n—data plus context.
3.3.11.1 Discussion—Data are of little value without con-
3. Terminology
text.The information value of a LIMS is related not only to the
3.1 This guide defines terminology used in the LIMS field.
quality of data stored, but also the context or relationships that
Paragraph 3.3 defines LIMS terms specific to this guide.
are maintained within the system.
Paragraph 3.1 provides references to other computer-related
3.3.12 LIMS, n—acronym for Laboratory Information Man-
technical terms used in this guide. LIMS vendors use many
agement System. Computer application(s) [software] and hard-
different terms to define the items listed in 3.3. Users of this
ware that can acquire, analyze, report, and manage data and
document should request a terminology list from each vendor
information in the laboratory.
with a cross reference to the terms used in this guide.
3.3.13 laboratory management, n—the monitoring and
3.2 Definitions—For definitions of terms relating to com-
control of a laboratory’s data management, and to a lesser
puterized systems, refer to Terminology E 1013, Guide E 622,
degree, laboratory resources.
Glossaries IEEE 100, IEEE 610, IEEE 729, andANSI X3.172.
3.3.14 login, n—registration of a sample in a LIMS.
3.3 Definitions of Terms Specific to This Standard:
3.3.15 profile, n—a group of one or more tests.
3.3.1 archive (1), n—data from a working database that has
3.3.15.1 Discussion—A predefined list of tests that are
been transferred to storage media for long term storage.
assigned to a LIMS sample during login.
3.3.1.1 Discussion—Information stored in the archive can
3.3.16 raw data, n—the original record of an observation.
be retrieved for reporting or additional processing.
3.3.16.1 Discussion—Data entered into the system directly
3.3.2 archive (2), v—the process of making an archive (1).
from original observations (not from a source document) by
3.3.2.1 Discussion—Allows erasure of data from the work-
keyboard or automatically by laboratory test devices are
ing database in order to free space for additional data.
considered raw data. Raw data is recorded on laboratory
3.3.3 audit trail, n—a record of events related to a transac-
worksheets,memoranda,notes,notebooks,andaretheresultof
tion including the original information and any changes to the
original observations and activities related to laboratory test-
information.
ing. Raw data may include photographs, microfilms, computer
3.3.3.1 Discussion—The audit trail may be composed of
printouts, magnetic media, and recorded data from automated
manual or computerized records of events and information, or
instruments.
both. The audit trail is used to reconstruct a series of related
3.3.17 results, n—smallest unit of test data input into the
events that have occurred.
LIMS.
3.3.17.1 Discussion—For example, an individual pH result.
See determination.
Available from American Iron and Steel Institute (AISI), 1140 Connecticut
3.3.18 reporting, v—extracting, organizing, and presenting
Ave., Suite 705, Washington, DC 20036.
information stored in a LIMS.
Available from International Standards Organization, 1 Rue de Varembe, Case
Postale 56, Crt 1221, Geneva, Switzerland.
3.3.19 sample, n—a small part of portion of a material or
Available from Analytical Instrument Assoc., 225 Reinekers Lane, Suite 625,
product intended to be a representative of the whole.
Alexandria, VA 22314.
3.3.19.1 Discussion—A LIMS sample may be further sub-
Available from National Institute for Standards and Technology, Gaithersburg,
MD 20899. divided into sub samples or aliquots.
E1578–93 (1999)
NOTE 1—LIMS Database: A computer database application that can acquire, analyze, report, and manage data and information in the laboratory.
Functional Areas: 1: Data/Information Capture, 2: Data Analysis, 3: Reporting, 4: Laboratory Management, 5: System Management.
Level Definitions: I: Minimum Core LIMS functions, II: Intermediate LIMS functions, and III: Advanced LIMS functions.
Global Items: Issues that have an impact on all LIMS functions. The global issues have different capability levels (I–III). Specific global items
include: Change Control (Configuration Management), Communication Infrastructures, Documentation, Performance, Quality, Security,
Training, User Interface, and Validation.
Information Domain: The environment into which LIMS delivers information.
External Systems: Computer systems that send and receive data/information to/from a LIMS.
FIG. 1 LIMS Concept Model
3.3.20 static tables, n—descriptive LIMS database tables database technology and structures, computer hardware plat-
where profiles, tests, calculations, specifications, and related forms, LIMS life cycle, LIMS costs and benefits, LIMS
information are defined and stored (commonly found in “look implementation guide and LIMS functions checklist. This
up/reference/dictionary” tables). guide will aid in LIMS selection, implementation, and use.
3.3.20.1 Discussion—LIMS stores look up information to This guide will improve the effectiveness of implemented
speed login and test assignments. Generally prior to login the LIMS through a better understanding of the LIMS structures
static tables need to be configured. Some LIMS implementa- and functions, and by expanding the horizon of the LIMS
tions can enter static table information directly from login step. information domain.
3.3.21 system management, n—monitoring and maintaining
5. LIMS Concept Model
the computer system.
3.3.22 test, n—operation performed on a sample.Atest may 5.1 The LIMS concept model is a graphical representation
result in one or more determinations. A test may include of the major components that comprise a LIMS. The concept
specifications and procedures for the determinations involved model can be used as a communication tool for defining LIMS
plus sample preparation and biographical information. functions to people in different disciplines. The diagram (Fig.
3.3.23 validation, n—establishing documented evidence 1) is composed of a circle in the middle representing a LIMS
which provides a high degree of assurance that a specific computer database. The LIMS database is surrounded by five
implementation of a LIMS will consistently meet its predeter- functional components: (1) Data/Information Capture, (2) Data
mined specifications and quality attributes. Analysis, (3) Reporting, (4) Laboratory Management, and (5)
3.3.24 verification, n—process of checking the accuracy of System Management. Three concentric rings expand out from
manually, or automatically (electronically) entered informa- the center and represent degrees of LIMS capabilities. Level 1
tion. depicts core (mandatory) LIMS functions. Level 2 represents
3.3.25 work flow, n—description of tasks performed within intermediate functions. Level 3 represents advanced functions
a laboratory, including sample flow, inputs, process and out-
and technology. The box that surrounds the inner circles
puts. represents global issues that have an impact on all parts of the
LIMS model. Global issues include: change control (configu-
4. Significance and Use
ration management), communication infrastructure, documen-
4.1 This guide includes information on LIMS terminology, tation, performance, quality, security, training, user interface,
a concept model, LIMS functions/work flow model, LIMS and validation.
E1578–93 (1999)
TABLE 1 LIMS Concept Model Sections
Level I—Minimum LIMS Functions
Global Issues LIMS Database Data/Information Capture Data Analysis Reporting Lab Management System Management
Change Control Manual Sample Login Result Verification Pre-Defined Reports Sample/Order Backup and Recovery
Status
Documentation Fixed Database Sample/Order
Structure Tracking
Quality Manual Result Entry Basic Calculations Sample Labels Backlog Report
Security Limited Capacity
User-Interface Limited Performance
Validation
Level II—Intermediate LIMS Functions
Global Issues LIMS Database Data/Information Capture Data Analysis Reporting Lab Management System Management
On-Line Documentation Intermediate Capacity On-Line from Comparison of Result User Defined Reports Scheduling of Lab Archiving
and Performance instruments (one-way
...

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

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

SIGNIFICANCE AND USE
3.1 The primary use of this guide is to provide a standardized approach for the data file to be used for the transfer of digital radiological data from one user to another where the two users are working with dissimilar systems. This guide describes the contents, both required and optional for an intermediate data file that can be created from the native format of the radiological system on which the data was collected and that can be converted into the native format of the receiving radiological data analysis system. This guide will also be useful in the archival storage and retrieval of radiological data as either a data format specifier or as a guide to the data elements which should be included in the archival file.  
3.2 Although the recommended field listing includes more than 100 field numbers, only about half of those are regarded as essential and are marked Footnote C in Table 1. Fields so marked must be included in the data base. The other fields recommended provide additional information that a user will find helpful in understanding the radiological image and examination result. These header field items will, in most cases, make up only a very small part of a radiological examination file. The actual stream of radiological data that make up the image will take up the largest part of the data base. Since a radiological image file will normally be large, the concept of data compression will be considered in many cases. Compressed data should be noted, along with a description of the compression method, as indicated in Field No. 92 (see Table 1). (A) Field numbers are for reference only. They do not imply a necessity to include all these fields in any specific data base nor imply a requirement that fields used be in this particular order.(B) Units listed first are SI; those in parentheses are inch-pound (English).(C) Denotes essential field for computerization of examination results, regardless of examination method.(D) Denotes essential field for radiogra...
SCOPE
1.1 This guide provides a listing and description of the fields that are recommended for inclusion in a digital radiological examination data base to facilitate the transfer of such data. This guide sets guidelines for the format of data fields for computerized transfer of digital image files obtained from radiographic, radioscopic, computed radiographic, or other radiological examination systems. The field listing includes those fields regarded as necessary for inclusion in the data base: (1) regardless of the radiological examination method (as indicated by Footnote C in Table 1), (2) for radioscopic examination (as indicated by Footnote F in Table 1), and (3) for radiographic examination (as indicated by Footnote D in Table 1). In addition, other optional fields are listed as a reminder of the types of information that may be useful for additional understanding of the data or applicable to a limited number of applications.  
1.2 It is recognized that organizations may have in place an internal format for the storage and retrieval of radiological examination data. This guide should not impede the use of such formats since it is probable that the necessary fields are already included in such internal data bases, or that the few additions can easily be made. The numerical listing and its order indicated in this guide is only for convenience; the specific numbers and their order carry no inherent significance and are not part of the data file.  
1.3 Current users of Guide E1475 do not have to change their software. First time users should use the XML structure of Table A1.1 for their data.  
1.4 The types of radiological examination systems that appear useful in relation to this guide include radioscopic systems as described in Guide E1000, Practices E1255, E1411, E2597, E2698 and E2737, and radiographic systems as described in Guide E94 and Practices E748, E1742, E2033, E2445, and E2446. Many of the terms used are def...

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

SIGNIFICANCE AND USE
5.1 The purpose of this practice is to provide data that can be used for comparison and evaluation of the accuracy of different CAS systems.  
5.2 The use of CAS systems and robotic tracking systems is becoming increasingly common and requires a degree of trust by the user that the data provided by the system meets necessary accuracy requirements. In order to evaluate the potential use of these systems, and to make informed decisions about suitability of a system for a given procedure, objective performance data of such systems are necessary. While the end user will ultimately want to know the accuracy parameters of a system under clinical application, the first step must be to characterize the digitization accuracy of the tracking subsystem in a controlled environment under controlled conditions.  
5.3 In order to make comparisons within and between systems, a standardized way of measuring and reporting point accuracy is needed. Parameters such as coordinate system, units of measure, terminology, and operational conditions must be standardized.
SCOPE
1.1 This standard will measure the effects on the accuracy of computer assisted surgery (CAS) systems of the environmental influences caused by equipment utilized for bone preparation during the intended clinical application for the system. The environmental vibration effect covered in this standard will include mechanical vibration from: cutting saw (sagittal or reciprocating), burrs, drills, and impact loading. The change in accuracy from detaching and re-attaching or disturbing a restrained connection that does not by design require repeating the registration process of a reference base will also be measured.  
1.2 It should be noted that one system may need to undergo multiple iterations (one for each clinical application) of this standard to document its accuracy during different clinical applications since each procedure may have different exposure to outside forces given the surgical procedure variability from one procedure to the next.  
1.3 All units of measure will be reported as millimeters for this standard.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM F2554-22(Practice)
Standard Practice for Measurement of Positional Accuracy of Computer-Assisted Surgical Systems

SIGNIFICANCE AND USE
5.1 The purpose of this practice is to provide data that can be used for evaluation of the accuracy of different CAS systems.  
5.2 The use of surgical navigation and robotic positioning systems is becoming increasingly common. In order to make informed decisions about the suitability of such systems for a given procedure, their accuracy capability needs to be evaluated under clinical application and compared to the requirements. As the performance of a whole system is constrained by those of its subparts, a preliminary step must be to objectively characterize the accuracy of the tracking subsystem in a controlled environment under controlled conditions.  
5.3 In order to make comparisons within and between systems, a standardized way of measuring and reporting accuracy is needed. Parameters such as coordinate system, units of measurement, terminology, and operational conditions must be standardized.
SCOPE
1.1 This document provides procedures for measurement and reporting of basic static performance of surgical navigation and/or robotic positioning devices under defined conditions. They can be performed on a subsystem (for example, tracking only) or a full computer-aided surgery system as would be used clinically. Testing a subsystem does not mean that the whole system has been tested. The functionality to be tested based on this practice is limited to the performance (accuracy in terms of bias and precision) of the system regarding point localization in space by means of a pointer. A point in space has no orientation; only multidimensional objects have orientation. Therefore, orientation of objects is not within the scope of this practice. However, in localizing a point the different orientations of the pointer can produce errors. These errors and the pointer orientation are within the scope of this practice. The aim is to provide a standardized measurement of performance variables by which end users can compare within a system (for example, with different reference elements or pointers) and between different systems (for example, from different manufacturers). Parameters to be evaluated include (based upon the features of the system being evaluated):
(1) Accuracy of a single point relative to a coordinate system.
(2) Sensitivity of tracking accuracy due to changes in pointer orientation.
(3) Relative point-to-point accuracy.  
1.1.1 This method covers all configurations of the evaluated system as well as extreme placements across the measurement volume.  
1.2 This practice defines a standardized reporting format, which includes definition of the coordinate systems to be used for reporting the measurements, and statistical measures (for example, mean, RMS, and maximum error).  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard, except for angular measurements, which may be reported in terms of radians or degrees.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM E2891-20(Guide)
Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications

SIGNIFICANCE AND USE
4.1 A significant amount of data is generated during pharmaceutical development and manufacturing activities. The interpretation of such data is becoming increasingly difficult. Individual examination of the univariate process variables is relevant but can be significantly complemented by multivariate data analysis (MVDA). MVDA may be particularly appropriate for exploring and handling large sets of heterogenous data, mapping data of high dimensionality onto lower dimensional representations, exposing significant correlations among multivariate variables within a single data set or significant correlations among multivariate variables across data sets. MVDA may extract statistically significant information which may enhance process understanding, decision making in process development, process monitoring and control (including product release), product life-cycle management, and continuous improvement.  
4.2 MVDA is widely used in various industries including the pharmaceutical industry. To achieve a valid outcome, an MVDA model/application should incorporate the following:  
4.2.1 A predefined risk-based objective incorporating one or more relevant scientific hypotheses specific to the application;  
4.2.2 Sufficient relevant data of requisite quality covering the variance space encountered during intended use, that is, pharmaceutical development, or pharmaceutical manufacturing, or both;  
4.2.3 Appropriate data analysis and model utilization practices including considerations on testing, validation, and qualification of all new data prior to using a model to analyze it;  
4.2.4 Appropriately trained staff;  
4.2.5 Appropriate standard operating procedures; and  
4.2.6 Life-cycle management.  
4.3 This guide can be used to support data analysis activities associated with pharmaceutical development and manufacturing, process performance and product quality monitoring in manufacturing, as well as for troubleshooting and investigation events. Technical detai...
SCOPE
1.1 This guide covers the applications of multivariate data analysis (MVDA) to support pharmaceutical development and manufacturing activities. MVDA is one of the key enablers for process understanding and decision making in pharmaceutical development, and for the release of intermediate and final products after being validated appropriately using a science and risk-based approach.  
1.2 The scope of this guide is to provide general guidelines on the application of MVDA in the pharmaceutical industry. While MVDA refers to typical empirical data analysis, the scope is limited to providing a high level guidance and not intended to provide application-specific data analysis procedures. This guide provides considerations on the following aspects:  
1.2.1 Use of a risk-based approach (understanding the objective requirements and assessing the fit-for-use status);  
1.2.2 Considerations on the data collection and diagnostics used for MVDA (including data preprocessing and outliers);  
1.2.3 Considerations on the different types of data analysis, model testing, and validation;  
1.2.4 Qualified and competent personnel; and  
1.2.5 Life-cycle management of MVDA model.  
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM E1935-97(2019)(Test Method)
Standard Test Method for Calibrating and Measuring CT Density

SIGNIFICANCE AND USE
5.1 This test method allows specification of the density calibration procedures to be used to calibrate and perform material density measurements using CT image data. Such measurements can be used to evaluate parts, characterize a particular system, or compare different systems, provided that observed variations are dominated by true changes in object density rather than by image artifacts. The specified procedure may also be used to determine the effective X-ray energy of a CT system.  
5.2 The recommended test method is more accurate and less susceptible to errors than alternative CT-based approaches, because it takes into account the effective energy of the CT system and the energy-dependent effects of the X-ray attenuation process.
FIG. 1 Density Calibration Phantom  
5.3 This (or any) test method for measuring density is valid only to the extent that observed CT-number variations are reflective of true changes in object density rather than image artifacts. Artifacts are always present at some level and can masquerade as density variations. Beam hardening artifacts are particularly detrimental. It is the responsibility of the user to determine or establish, or both, the validity of the density measurements; that is, they are performed in regions of the image which are not overly influenced by artifacts.  
5.4 Linear attenuation and mass attenuation may be measured in various ways. For a discussion of attenuation and attenuation measurement, see Guide E1441 and Practice E1570.
SCOPE
1.1 This test method covers instruction for determining the density calibration of X- and γ-ray computed tomography (CT) systems and for using this information to measure material densities from CT images. The calibration is based on an examination of the CT image of a disk of material with embedded specimens of known composition and density. The measured mean CT values of the known standards are determined from an analysis of the image, and their linear attenuation coefficients are determined by multiplying their measured physical density by their published mass attenuation coefficient. The density calibration is performed by applying a linear regression to the data. Once calibrated, the linear attenuation coefficient of an unknown feature in an image can be measured from a determination of its mean CT value. Its density can then be extracted from a knowledge of its mass attenuation coefficient, or one representative of the feature.  
1.2 CT provides an excellent method of nondestructively measuring density variations, which would be very difficult to quantify otherwise. Density is inherently a volumetric property of matter. As the measurement volume shrinks, local material inhomogeneities become more important; and measured values will begin to vary about the bulk density value of the material.  
1.3 All values are stated in SI units.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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