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ASTM E2538-06

(Practice)

Standard Practice for Defining and Implementing Pharmacotherapy Information Services within the Electronic Health Record (EHR) Environment and Networked Architectures

Standard Practice for Defining and Implementing Pharmacotherapy Information Services within the Electronic Health Record (EHR) Environment and Networked Architectures

SCOPE
1.1 This practice applies to the process of defining and documenting the capabilities, logical data sources, and pathways of data exchange regarding pharmacotherapy information services within a given network architecture serving a set of healthcare constituents.
1.2 This practice is not a technical implementation standard but, rather, describes how the implementation methods and techniques can be used to coordinate pharmacotherapy services logically within an electronic health record (EHR) systems environment involving participating organizations and sites connected by a networked communication system.
1.3 This practice covers the content of the nodes and arcs of the resulting logical network involving EHR, pharmacy, and clinical laboratory-capable sites. This practice also considers the various purposes and organizational arrangements for coordinating pharmacotherapy services within the network boundaries and the considerations for connections among external networks.
1.4 This practice refers to other standards for conventions within various data domains, such as pharmacy systems, clinical laboratory information management systems (CLIMS), and EHR systems, and for messaging conventions.
1.5 This practice is intended to outline how integration of pharmacy, CLIMS, and EHR information systems can be undertaken to result in a transparent pharmacotherapy clinical decision support environment, regardless of the underlying implementation architecture, by describing the logical interoperability of information domains as facilitated by information and communications technology (ICT).
1.6 This practice is directed at pharmacists, clinical pharmacologists, clinical laboratorians, information system managers, and information systems vendors for use in planning and implementing coordinated pharmacotherapy services through effective dialog.
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
30-Nov-2006
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 E2538-06(2011) - Standard Practice for Defining and Implementing Pharmacotherapy Information Services within the Electronic Health Record (EHR) Environment and Networked Architectures (Withdrawn 2020)
Effective Date
01-May-2011

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ASTM E2538-06 - Standard Practice for Defining and Implementing Pharmacotherapy Information Services within the Electronic Health Record (EHR) Environment and Networked ArchitecturesASTM E2538-06 - Standard Practice for Defining and Implementing Pharmacotherapy Information Services within the Electronic Health Record (EHR) Environment and Networked Architectures
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ASTM E2538-06 - Standard Practice for Defining and Implementing Pharmacotherapy Information Services within the Electronic Health Record (EHR) Environment and Networked Architectures
English language
39 pages
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Standards Content (Sample)


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: E2538 – 06
Standard Practice for
Defining and Implementing Pharmacotherapy Information
Services within the Electronic Health Record (EHR)
Environment and Networked Architectures
This standard is issued under the fixed designation E2538; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 1.7 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
1.1 This practice applies to the process of defining and
responsibility of the user of this standard to establish appro-
documenting the capabilities, logical data sources, and path-
priate safety and health practices and determine the applica-
waysofdataexchangeregardingpharmacotherapyinformation
bility of regulatory limitations prior to use.
services within a given network architecture serving a set of
healthcare constituents.
2. Referenced Documents
1.2 This practice is not a technical implementation standard
2.1 ASTM Standards:
but, rather, describes how the implementation methods and
E1239 PracticeforDescriptionofReservation/Registration-
techniquescanbeusedtocoordinatepharmacotherapyservices
Admission, Discharge, Transfer (R-ADT) Systems for
logically within an electronic health record (EHR) systems
Electronic Health Record (EHR) Systems
environment involving participating organizations and sites
E1340 GuideforRapidPrototypingofInformationSystems
connected by a networked communication system.
E1384 Practice for Content and Structure of the Electronic
1.3 This practice covers the content of the nodes and arcs of
Health Record (EHR)
the resulting logical network involving EHR, pharmacy, and
E1578 Guide for Laboratory Information Management Sys-
clinical laboratory-capable sites. This practice also considers
tems (LIMS)
the various purposes and organizational arrangements for
E1633 Specification for Coded Values Used in the Elec-
coordinating pharmacotherapy services within the network
tronic Health Record
boundaries and the considerations for connections among
E1714 Guide for Properties of a Universal Healthcare
external networks.
Identifier (UHID)
1.4 This practice refers to other standards for conventions
E1715 Practice forAn Object-Oriented Model for Registra-
within various data domains, such as pharmacy systems,
tion, Admitting, Discharge, and Transfer (RADT) Func-
clinicallaboratoryinformationmanagementsystems(CLIMS),
tions in Computer-Based Patient Record Systems
and EHR systems, and for messaging conventions.
E1744 Practice for View of Emergency Medical Care in the
1.5 This practice is intended to outline how integration of
Electronic Health Record
pharmacy, CLIMS, and EHR information systems can be
E1762 Guide for Electronic Authentication of Health Care
undertaken to result in a transparent pharmacotherapy clinical
Information
decision support environment, regardless of the underlying
E1869 Guide for Confidentiality, Privacy,Access, and Data
implementation architecture, by describing the logical interop-
Security Principles for Health Information Including Elec-
erability of information domains as facilitated by information
tronic Health Records
and communications technology (ICT).
E1985 Guide for User Authentication and Authorization
1.6 This practice is directed at pharmacists, clinical phar-
E1986 Guide for Information Access Privileges to Health
macologists, clinical laboratorians, information system manag-
Information
ers, and information systems vendors for use in planning and
implementing coordinated pharmacotherapy services through
effective dialog.
This practice is under the jurisdiction ofASTM Committee E31 on Healthcare
Informatics and is the direct responsibility of Subcommittee E31.25 on Healthcare For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Data Management, Security, Confidentiality, and Privacy. contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Current edition approved Dec. 1, 2006. Published January 2007. DOI: 10.1520/ Standards volume information, refer to the standard’s Document Summary page on
E2538-06. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
E2538 – 06
E1987 Guide for Individual Rights Regarding Health Infor- ANSI/IEEE 1320.1y 1998 (R2004) Standard for Concep-
mation tual Modeling Language—Syntax and Semantics for
E1988 Guide for Training of Persons who have Access to IDEF0
Health Information ANSI/IEEE 1320.2y 1998 (R2004) Standard for Concep-
E2017 Guide for Amendments to Health Information tual Modeling Language—Syntax and Semantics for
E2066 Guide for Validation of Laboratory Information IDEF1X97 (IDEF Object)
Management Systems
ANSI/IEEE 1362y 1998 Guide for Information
E2084 Specification forAuthentication of Healthcare Infor- Technology—System Definition—Concept of Operations
mation Using Digital Signatures
Document
E2085 Guide on Security Framework for Healthcare Infor- ANSI/IEEE 1490y 2003 IEEE Guide IEEE—Adoption of
mation
PMI Standard—AGuide to Project Management Body of
E2086 Guide for Internet and Intranet Healthcare Security Knowledge, 2000 Edition PMI
E2145 Practice for Information Modeling
ANSI/IEEE 12207.0y 1996 Standard for Information
E2147 Specification forAudit and Disclosure Logs for Use
Technology—Software Life Cycle Processes
in Health Information Systems
ANSI/IEEE 12207.1y 1997 Guide for Information
E2171 Practice for Rating-Scale Measures Relevant to the
Technology—Software Life Cycle Processes—Life Cycle
Electronic Health Record
Data
E2457 Terminology for Healthcare Informatics
ANSI/IEEE 12207.2y 1997 Guide for Information
E2473 Practice for the Occupational/Environmental Health
Technology—Software Life Cycle Processes—
View of the Electronic Health Record
Implementation Considerations
P110 Proposed Guide to Assist in the Defining, Procuring,
2.3 ANSI/HL7 Standards:
Installing, and Implementing of a Computerized Hospital
ANSI/HL7 Interface Standard v2.4, v2.5, v3.0
Pharmacy System
HL7 Message Development Framework v3.3, Dec. 1999
2.2 ANSI/IEEE Standards:
2.4 ANSI/ADA Standards:
ANSI X3.172 American National Dictionary for Informa-
ANSI/ADA TR 1039 2005 Clinical Content Data Model
tion Systems
ANSI/ADA 1000.0 Introduction, Model Architecture, and
ANSI/IEEE 610.12y 1990 (R2002) Standard Glossary of
Specification Framework
Software Engineering Terminology
ANSI/ADA 1000.1 Individual Identification
ANSI/IEEE 830y 1998 Software Requirements Specifica- ANSI/ADA 1000.2 Codes and Nomenclature
tion
ANSI/ADA 1000.3 Individual Characteristics
ANSI/IEEE 1058y 1998 Software Project Management ANSI/ADA 1000.4 Population Characteristics
Plans ANSI/ADA 1000.5 Organization
ANSI/IEEE 1062y 1998 (R2002 includes 1062a) Recom- ANSI/ADA 1000.6 Location
mended Practice for Software Acquisition ANSI/ADA 1000.7 Communication
ANSI/IEEE 1063y 2001 Software User Documentation ANSI/ADA 1000.8 Healthcare Event
ANSI/ADA 1000.9 Health Materiel
ANSI/IEEE 1073y 1996 Framework and Overview
ANSI/ADA 1000.10 Health Services
ANSI/IEEE 1073.3.1y 2001/Amd1-2001 Transport Profile
ANSI/ADA 1000.11 Health Service Resources
(redesignated 11073-3-1, Standard for Medical Device
ANSI/ADA 1000.12 Population Health Facts
Communications-Transport Profile-Connection Mode)
ANSI/ADA 1000.13 Patient Health Facts
ANSI/IEEE 1073.4.1y 2001 Physical Layer-Cable Con-
ANSI/ADA 1000.14 Health Condition Diagnosis
nected (redesignated 11073-4-1, Standard for Medical
ANSI/ADA 1000.15 Health Service Plan
Device Communications—Physical Layer Interface—
ANSI/ADA 1000.16 Patient Health Service
Cable Connection)
ANSI/ADA 1000.17 Clinical Investigation
ANSI/IEEE 1074y 2006 Standard for Developing Life
ANSI/ADA 1000.18 Comments Subject Area
Cycle Processes
2.5 ISO Standards:
ANSI/IEEE 1074.1y 1995 Guide for Developing Life
ISO/IECTR 9789 InformationTechnology—Guidelines for
Cycle Processes
the Organization and Representation of Data Elements for
ANSI/IEEE 1220y 2005 Standard for Application and
Data Interchange-Coding Methods and Principles
Management of the System Engineering Process
ISO 12200 Computer Applications in Terminology—
ANSI/IEEE 1233y 1998 (R2002 includes 1233a) Guide to
Machine-Readable Terminology Interchange Format
Preparing System Requirements Specifications
(MARTIF)—Negotiated Interchange
ISO 12620 Computer Applications in Terminology—Data
Categories
Withdrawn. The last approved version of this historical standard is referenced
ISO IS 12207 Information Technology—Software Life
on www.astm.org.
Cycle Processes
Withdrawn 1988.
ISO IS 15188 Project Management Guidelines for Termi-
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
4th Floor, New York, NY 10036, http://www.ansi.org. nology Standardization
E2538 – 06
ISO 15189 Quality Management in the Clinical Laboratory men Tubes in the Clinical Laboratory
ISO DIS 15193 Measurement of Quantities in Samples of
CLSI LIS-8A Guide for Functional Requirements of Clini-
Biologic Origin—Reference Methods
cal Laboratory Information Management Systems
ISO DIS 15194 Measurement of Quantities in Samples of
CLSI LIS-9A Guide for Coordination of Clinical Labora-
Biologic Origin—Reference Materials
tory Services in an Electronic Health Record Environment
ISO 15195 Requirements for Reference Measurement
and Networked Architectures
Laboratories
CLSI POCT1 Point of Care Connectivity
ISO WD 15288 System Life Cycle Processes
DICOM Supplement 15 Visible Light Image, Anatomic
ISO 15440 Guide for Life Cycle Processes
Frame of Reference, Accession and Specimen for Endos-
ISO 17511 Traceability of Calibration and Control Materi-
copy, Microscopy, and Photography
als
EIA/IEEE J-Std-016 Standard for Information Technology,
2.6 Other Standards:
Software Life Cycle Processes, Software Development,
AAMI SW68:2001 Medical Device Software-Software Life 10
Acquirer-Supplier Agreement
Cycle Processes
IUPAC/IFCC Silver Book: Compendium of Terminology
ANSI X12
and Nomenclature of Properties in Clinical Laboratory
CEN ENV 1613 Medical Informatics—Messages for the
Sciences
exchange of laboratory information
IUPAC/IFCC Properties and Units in Clinical Laboratory
CEN ENV 1614 Healthcare Informatics—Structure for no-
Sciences X Properties and Units in General Clinical
menclature, classification and coding of properties in
Chemistry
clinical laboratory sciences
IUPAC/IFCC Properties and Units in Clinical Laboratory
CEN EN 12017 Medical Informatics Vocabulary (MIVoc)
Sciences XII Properties and Units in Clinical Pharmacol-
CEN EN 12264 Categorical Structures of Systems of
ogy and Toxicology
Concepts—Model for Representation of Semantics
NCPDP SCRIPT v9.0
(MOSE)
RxNorm
Internet RFC 1521 N. Borenstein, N Freed MIME [Multi-
purposeInternet Mail Extensions] Purpose: Mechanisms
3. Terminology
for Specifying and Designating the Format of Internet
Message Bodies Bellcore Innosoft Sept. 1993 3.1 Definitions—Terminology related to general informa-
ANSI/CLSI ASTP2 Point of Care In-vitro Diagnostic Test- tion systems appears inANSI X3.172 andANSI/IEEE 610.12.
ing Terminology relating generally to healthcare information ap-
CLSI AUTO1-A Laboratory Automation: Specimen pears in CEN EN 12264 and CEN EN 12017, Terminology
Container/Specimen Carrier E2457, and Unified Medical Language System (UMLS). The
CLSI AUTO2-A Laboratory Automation: Bar codes for terms used frequently from these sources appear here, in
Specimen Container Identification addition to those terms specific to this practice.
CLSI AUTO3-A Laboratory Automation: Communications
3.2 Definitions of Terms Specific to This Standard:
with Automated Clinical Laboratory Systems, Instru- 3.2.1 health information network, n—set of data domains
ments, Devices and Information Systems
(nodes) and communications pathways (arcs) serving a health-
CLSI AUTO4-A Laboratory Automation: Systems Opera- care constituency with information management services.
tional Requirements, Characteristics and Information El-
3.2.2 identifier, n—symbol used to name, indicate, or lo-
ements cate. ANSI/IEEE 610.12
CLSI AUTO5-A Laboratory Automation: Electromechani-
3.2.2.1 Discussion—Identifiersmaybeassociatedwithsuch
cal Interfaces things as data structures, data items, or program locations.
CLSI LIS-1A Specification for Low Level Protocol to
3.2.3 practitioner, licensed, n—individual at any level of
Transfer Messages between Clinical Laboratory Instru- professional specialization who requires a public license/
ments and Computer Systems certification to practice the delivery of care to patients.
CLSI LIS-2A Specification for Transferring Information E1384
between Clinical Instruments and Computer Systems 3.2.3.1 Discussion—A practitioner may also be a provider.
CLSI LIS-3A Guide for Procurement of a Clinical Labora- 3.2.4 provider, n—business entity that furnishes healthcare
tory Information Management System (CLIMS) to a consumer. E1384
CLSI LIS-5A Specification for Transferring Clinical Obser-
vations between Independent Computer Systems
CLSI LIS-7A Specification for Use of Bar Codes on Speci-
Available from NEMA, Suite 1752, 1300 N. 17th St., Rosslyn, VA 22209.
Available from the Institute of Electrical and Electronics Engineers, Inc., 1828
L St., NW, Suite 1202, Washington, DC 20036-5104.
6 11
Available from the Association for Advancement of Medical Instrumentation, Available from the IUPAC Secretariat, PO Box 13757, Research Triangle
1110 N. Glebe Rd., Suite 220, Arlington, VA 22201-4795. Park, NC 27709-3757.
7 12
Available from the European Committee for Standardization, 36 rue de Available from the National Council for Prescription Drug Programs, 9240 E.
Stassart, B-1050 Brussels, Belgium. Raintree Dr., Scottsdale, AZ 85260-7518.
8 13
AvailablefromtheClinicalandLaboratoryStandardsInstitute,940WestValley Available from Reference and Web Services, National Library of Medicine,
Rd., Suite 1400, Wayne, PA 19087-1898. 8600 Rockville Pike, Bethesda, MD 20894.
E2538 – 06
3.2.4.1 Discussion—This term includes a professionally than a single IDS itself and are buying such services for
licensed practitioner who is authorized to operate a healthcare themselves rather than offering them internally.
delivery facility. 4.3 These organizations will need a frame of reference for
3.3 Acronyms—The following acronyms are used in
...

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ASTM E2147-18(Specification)
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ABSTRACT
This specification describes the security requirements involved in the development and implementation of audit and disclosure logs used in health information systems. It specifies how to design an access audit log to record all access to patient identifiable information maintained in computer systems, and includes principles for developing policies, procedures, and functions of health information logs to document all disclosure of confidential health care information to external users for use in manual and computer systems. This specification provides for two main purposes, namely: to define the nature, role, and function of system access audit logs and their use in health information systems as a technical and procedural tool to help provide security oversight; and to identify principles for establishing a permanent record of disclosure of health information to external users and the data to be recorded in maintaining it.
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5.1 Personnel that are responsible for the creation, transfer, and storage of X-ray tomographic NDE data will use this standard. This practice defines a set of information modules that along with Practice E2339 and the DICOM standard provide a standard means to organize X-ray tomography test parameters and results. The X-ray CT test results may be displayed and analyzed on any device that conforms to this standard. Personnel wishing to view any tomographic 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.
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Standard Practice for Digital Imaging and Communication in Nondestructive Evaluation (DICONDE) for Computed Radiography (CR) Test Methods

SIGNIFICANCE AND USE
5.1 Personnel that are responsible for the creation, transfer, and storage of computed radiography NDE data will use this practice. This practice will define a set of information modules that along with the Practice E2339 and the DICOM standard will provide a standard means to organize CR inspection data. The CR inspection data may be displayed and analyzed on any device that conforms to the standard. Personnel wishing to view any CR inspection data stored in accordance with Practice E2339 may use this practice to help them decode and display the data contained in the DICONDE compliant inspection record.
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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