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ASTM E1381-95

(Specification)

Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems

Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems

SCOPE
1.1 This specification describes the electronic transmission of digital information between clinical laboratory instruments and computer systems. The clinical laboratory instruments under consideration are those that measure one or more parameters from one or more patient samples. Often they will be automated instruments that measure many parameters from many patient samples. The computer systems considered here are those that are configured to accept instrument results for further processing, storage, reporting, or manipulation. This instrument output may include patient results, quality control results, and other related information. Typically, the computer system will be a Laboratory Information Management System (LIMS).
1.2 The terminology of the Organization for International Standards (ISO) Reference Model for Open Systems Interconnection (OSI) is generally followed in describing the communications protocol and services. The electrical and mechanical connection between instrument and computer is described in the Physical Layer section. The methods for establishing communication, error detection, error recovery, and sending and receiving of messages are described in the Data Link Layer section. The data link layer interacts with higher layers in terms of sends and receives "messages," handles data link connection and release requests, and reports the data link status.
1.3 Specification E 1394 is concerned with message content in the interface between clinical instruments and computer systems. The major topics are found in the following sections: SectionPhysical Layer5Overview 5.1Electrical Characteristics5.2 Signal Levels 5.2.1Character Structure 5.2.2Speed5.2.3Interface Connections5.2.4Mechanical Characteristics 5.3Connector5.3.1 Cable 5.3.2Data Link Layer6 Overview 6.1Establishment Phase (Link Connection)6.2Contention6. 2.1 Transfer Phase6.3 Frames 6.3.1Frame Number6.3.2 Checksum 6.3.3Acknowledgments 6.3.4Receiver Interrupts6.3.5 Termination Phase (Link Release)6.4Error Recovery6.5 Defective Frames6.5.1 Timeouts 6.5.2Restricted Message Characters6.6

General Information

Status
Historical
Publication Date
31-Dec-1994
ICS
35.240.80 - IT applications in health care technology
Technical Committee
E31 - Healthcare Informatics
Current Stage
Ref Project

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ASTM E1381-95 - Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer SystemsASTM E1381-95 - Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems
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ASTM E1381-95 - Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems
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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.
An American National Standard
Designation: E 1381 – 95
Standard Specification for
Low-Level Protocol to Transfer Messages Between Clinical
Laboratory Instruments and Computer Systems
This standard is issued under the fixed designation E 1381; 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
Data Link Layer 6
Overview 6.1
1.1 This specification describes the electronic transmission
Establishment Phase (Link Connection) 6.2
of digital information between clinical laboratory instruments Contention 6.2.1
Transfer Phase 6.3
and computer systems. The clinical laboratory instruments
Frames 6.3.1
under consideration are those that measure one or more
Frame Number 6.3.2
parameters from one or more patient samples. Often they will
Checksum 6.3.3
Acknowledgments 6.3.4
be automated instruments that measure many parameters from
Receiver Interrupts 6.3.5
many patient samples. The computer systems considered here
Termination Phase (Link Release) 6.4
are those that are configured to accept instrument results for
Error Recovery 6.5
Defective Frames 6.5.1
further processing, storage, reporting, or manipulation. This
Timeouts 6.5.2
instrument output may include patient results, quality control
Restricted Message Characters 6.6
results, and other related information. Typically, the computer
2. Referenced Documents
system will be a Laboratory Information Management System
(LIMS).
2.1 ASTM Standards:
1.2 The terminology of the Organization for International
E 1394 Specification for Transferring Information Between
Standards (ISO) Reference Model for Open Systems Intercon-
Clinical Instruments and Computer Systems
nection (OSI) is generally followed in describing the commu-
2.2 ANSI Standards:
nications protocol and services. The electrical and mechanical
X3.4-1986 American National Standard Code for Informa-
connection between instrument and computer is described in
tion Systems—Coded Character Sets—7-Bit American
the Physical Layer section. The methods for establishing
National Standard Code for Information Interchange (7-
communication, error detection, error recovery, and sending
Bit ASCII)
and receiving of messages are described in the Data Link Layer X3.15-1976 American National Standard for Bit Sequenc-
section. The data link layer interacts with higher layers in terms
ing of the American National Standard Code for Informa-
of sends and receives “messages,” handles data link connection tion Interchange in Serial-by-Bit Data Transmission
and release requests, and reports the data link status.
X3.16-1976 American National Standard Character Struc-
1.3 Specification E 1394 is concerned with message content ture and Character Parity Sense for Serial-by-Bit Data
in the interface between clinical instruments and computer
Communication in the American National Standard Code
systems. The major topics are found in the following sections:
for Information Interchange
Section 2.3 ISO Standard:
Physical Layer 5
International Standard ISO 7498-1984(E), Information Pro-
Overview 5.1
cessing Systems—Open Systems Interconnection—Basic
Electrical Characteristics 5.2
Signal Levels 5.2.1 Reference Model, International Organization for Stan-
Character Structure 5.2.2
dardization
Speed 5.2.3
2.4 Other Document:
Interface Connections 5.2.4
Mechanical Characteristics 5.3
EIA-232-D-1986 Interface Between Data Terminal Equip-
Connector 5.3.1
ment and Data Circuit-Terminating Equipment Employing
Cable 5.3.2
Serial Binary Data Interchange
1 2
This specification is under the jurisdiction of ASTM Committee E31 on Annual Book of ASTM Standards, Vol 14.01.
Healthcare Informatics and is the direct responsibility of Subcommittee E31.13 on Available from American National Standards Institute, 11 W. 42nd St., 13th
Clinical Laboratory Systems. Floor, New York, NY 10036.
Current edition approved Oct. 10, 1995. Published January 1996. Originally Available from Electronics Industries Association, 2001 I Street, N.W., Wash-
published as E 1381 – 91. Last previous edition E 1381 – 91. ington, DC 20006.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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.
E 1381
3. Terminology tion corresponds to a voltage more negative than minus three
volts with respect to signal ground at the interface point. A
3.1 receiver—the device that responds to the sender and
spacing condition corresponds to a voltage more positive than
accepts the message.
plus three volts with respect to signal ground at the interface
3.2 sender—the device that has a message to send and
point.
initiates the transmission process.
5.2.1.2 Binary state ONE (1) corresponds to the marking
3.3 The parts of a communication between instrument and
condition; binary state ZERO (0) corresponds to the spacing
computer are identified by the following terms. The parts are
condition.
hierarchical and are listed in order of most encompassing first.
5.2.1.3 The signal levels conform to the EIA-232-D-1986
3.4 session—a total unit of communication activity, used in
standard.
this standard to indicate the events starting with the establish-
ment phase and ending with the termination phase, as de- 5.2.2 Character Structure:
scribed in subsequent sections.
5.2.2.1 The method of data transmission is serial-by-bit
3.5 message—a collection of related information on a single
start/stop. The order of the bits in a character is:
topic, used here to mean all the identity, tests, and comments
(1) One start bit, corresponding to a binary 0,
sent at one time. When used with Specification E 1394, this
(2) The data bits of the character, least significant bit
term means a record as defined by Specification E 1394.
transmitted first,
3.6 frame—a subdivision of a message, used to allow
(3) Parity bit,
periodic communication housekeeping such as error checks
(4) Stop bit(s), corresponding to a binary 1.
and acknowledgements.
5.2.2.2 The time between the stop bit of one character and
4. Significance and Use
the start bit of the next character may be of any duration. The
data interchange circuit is in the marking condition between
4.1 Nearly all recent major clinical instruments have provi-
characters.
sion for connection to a computer system, and in nearly all
5.2.2.3 Even parity corresponds to a parity bit chosen in
laboratories that have implemented a LIMS, there is a need to
such a way that there are an even number of ONE bits in the
connect the laboratory’s high volume automated instruments to
sequence of data bits and parity bit. Odd parity corresponds to
the LIMS so that results can be transferred automatically. To
an odd number of ONE bits when formed in the same way.
accomplish this connection, both the instrument and the
computer must have compatible circuits and appropriate soft- 5.2.2.4 All devices must be capable of sending and receiv-
ware, and there must be a proper cable to connect the two ing characters consisting of one start bit, eight data bits, no
systems. parity bit, and one stop bit.
4.1.1 Without this standard specification, the interface be-
5.2.2.5 The default character structure consists of one start
tween each different instrument and each different computer
bit, eight data bits, no parity bit, and one stop bit. Eight data bit
system is likely to be a different product. This increases the
character sets are allowed but not specified by this standard.
cost, the chances for compatibility problems, and the difficulty
Other character structures can be used for specialized applica-
of specifying and designing a proper system. In addition,
tions, for example, seven data bits, odd, even, mark or space
interfaces for every instrument-computer combination may not
parity, or two stop bits.
be available, forcing expensive and time-consuming custom
5.2.2.6 The character bit sequencing, structure, and parity
development projects.
sense definitions conform to ANSI standards X3.15-1976 and
4.2 This standard specification defines the electrical param-
X3.16-1976.
eters, cabling, data codes, transmission protocol, and error
5.2.3 Speed:
recovery for the information that passes between the instru-
5.2.3.1 The data transmission rate for instruments shall be at
ment and the laboratory computer. It is expected that future
least one of these baud rates: 1200, 2400, 4800, or 9600 baud.
products from instrument manufacturers and computer system
The preferred rate is 9600 baud and should be the default
developers, released after the publication of this specification,
setting of the instrument when more than one baud rate is
will conform to this specification, and that will lead to
available. The computer system must have the capability for all
plug-together compatibility of clinical instruments and com-
four baud rates.
puter systems.
5.2.3.2 Devices may optionally have the capability for other
baud rates such as 300, 19 200, and 38 400 baud for use in
5. Physical Layer
specialized applications.
5.1 Overview—The mechanical and electrical connection
5.2.4 Interface Connections:
for serial binary data bit transmission between instrument and
5.2.4.1 The conforming connection specified here defines
computer system is described in the physical layer. The
the point of interconnection between the domain of the
topology is point-to-point, a direct connection between two
instrument and domain of the computer system. (See Fig. 1 and
devices.
Fig. 2.) Within the domain of either device, any appropriate
5.2 Electrical Characteristics—The voltage and impedance
connection system may be used, preferably with suitable cable
levels for the generator and receiver circuits are as specified in
locking hardware.
the EIA-232-D-1986 standard.
5.2.1 Signal Levels: 5.2.4.2 The conforming connection utilizes a 25-position
5.2.1.1 For the data interchange circuits, a marking condi- connector. The connector contact assignments are listed in
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.
E 1381
FIG. 1 Connector Strategy for Instrument Computer
Connection—Cable Mounted
FIG. 2 Connector Strategy for Instrument Computer
Connections—Chassis Mounted
Table 1. Connector contacts not listed are unused. The connec- 5.3.1.4 When the conforming connector of the instrument is
tor contact assignments conform to the EIA-232-D-1986 stan- cable mounted and the conforming connector of the computer
dard for the circuits that are used. is chassis mounted, then a change in the cable mounted locking
5.2.4.3 Contact 1 is the shield connection, it connects to the hardware is necessary.
instrument’s (the DTE) frame. The shield connection is left 5.3.2 Cable—Any extension cables to connect the instru-
open at the computer (the DCE) to avoid ground loops. There ment to the computer require a female connector on one end to
will be no connections on any other pins. All other pins will be mate with the instrument and a male connector on the other end
open circuits. to mate with the computer. Detailed requirements of an
5.3 Mechanical Characteristics: interconnecting cable are undefined but good engineering
5.3.1 Connector: practice should be followed in selecting the cable and connec-
5.3.1.1 The conforming connector associated with the in- tors. Shielded cable and connectors may be necessary to
strument is a commercial type DB-25P (subminiature D male) suppress electromagnetic interface (EMI). Low capacitance
style connector. The conforming connector associated with the cable may be necessary for long cable lengths or the higher
computer is a commercial type DB-25S (subminiature D data rates. Appropriate connector locking hardware should be
female) style connector. The connector dimensions must cor- used at the conforming connectors.
respond to those given in the EIA-232-D-1986 standard.
6. Data Link Layer
5.3.1.2 When the conforming connector of the instrument is
6.1 Overview—The data link layer has procedures for link
cable mounted, it shall be configured with a locking device
connection and release, delimiting and synchronism, sequential
such as No. 4-40 or M-3 thread female screw locking hard-
ware. When the conforming connector of the computer is cable control, error detection, and error recovery.
6.1.1 Link connection and release establish which system
mounted, it shall be configured with a locking device such as
No. 4-40 or M-3 thread male screw locking hardware. (See Fig. sends and which system receives information. Delimiting and
synchronism provide for framing of the data and recognition of
1.)
5.3.1.3 When the conforming connector of either device is frames. Sequence control maintains the sequential order of
information across the connection. Error detection senses
chassis mounted, it shall be configured with devices such as
No. 4-40 or M-3 thread female screw locking hardware. The transmission or format errors. Error recovery attempts to
recover from detected errors by retransmitting defective frames
mating cable connector shall use devices such as No. 4-40 or
M-3 thread male screw locking hardware. (See Fig. 2.) or returning the link to a neutral state from otherwise unrecov-
erable errors.
6.1.2 The data link layer uses a character-oriented protocol
TABLE 1 Connector Contact Assignments
to send messages between directly connected systems. (See
Direction
ANSI X3.4-1986. Also, see Appendix X1 for the coding of the
Contact No. EIA Circuit Description
Instrument Computer
ASCI characters.) Some restrictions are placed on the charac-
1 . Shield . No Connection ters which can appear in the message content.
2 BA Transmitted Data Output Input
6.1.3 The data link mode of operation is one-way transfer of
3 BB Received Data Input Output
information with alternate supervision. Information flows in
7 AB Signal Ground . .
one direction at a time. Replies occur after information is sent,
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.
E 1381
never at the same time. It is a simplex stop-and-wait protocol. frame. Every message must begin in a new frame.
6.1.4 At times, the two systems are actively operating to 6.3.1.2 A frame is one of two types, an
...

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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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