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ASTM E1579-94

(Guide)

Standard Guide for Ensuring Data Integrity in Highly Computerized Laboratory Operations (Withdrawn 2002)

Standard Guide for Ensuring Data Integrity in Highly Computerized Laboratory Operations (Withdrawn 2002)

SCOPE
1.1 This guide covers general requirements for data integrity for computer operations in a laboratory. This guide expands upon the requirements of paragraph 10.7 in ISO/ IEC Guide 25 (currently being balloted as a replacement for Guide E548) for those laboratories that are highly computerized and is intended to be used in conjunction with ISO/IEC Guide 25 in the assessment of testing laboratories.  
1.2 This guide presents requirements that are generally in harmony with and in addition to those in Guide E548 and ISO/IEC Guide 25; the paragraphs dealing with similar subjects carry similar numbers.  
1.3 Additional requirements may be necessary for fields of testing where the computer system(s) are integrated into the test methods themselves. These requirements can normally be found in the test methods.  
1.4 In highly computerized laboratories, computers are increasingly being used for:  
1.4.1 Direct capture of data from instruments and testing machines;  
1.4.2 Automatic control and monitoring of test processes;  
1.4.3 Control of critical environmental conditions;  
1.4.4 Capture, processing, and display of laboratory quality-control data;  
1.4.5 Basic data processing;  
1.4.6 Data storage and retrieval;  
1.4.7 Generation of test reports;  
1.4.8 Scheduling and monitoring of work throughput;  
1.4.9 Monitoring and control of inventories;  
1.4.10 Equipment inventories, and calibration and maintenance schedules;  
1.4.11 Design of statistical experiments; and  
1.4.12 Communication between laboratories (and with clients).  
1.5 The assessment of the highly computerized laboratory will depend upon the nature of the computer systems and the functions they are intended to perform. This guide may be useful in assessing portions of computer systems in less highly computerized laboratories.  
1.6 This standard does not purport to address all of the safety problems, 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
Withdrawn
Publication Date
14-Oct-1994
Withdrawal Date
09-Dec-2002
ICS
35.240.80 - IT applications in health care technology
Technical Committee
E36 - Accreditation & Certification
Drafting Committee
E36.10 - Laboratory/Inspection Standards
Current Stage
Ref Project

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ASTM E1579-94 - Standard Guide for Ensuring Data Integrity in Highly Computerized Laboratory Operations (Withdrawn 2002)ASTM E1579-94 - Standard Guide for Ensuring Data Integrity in Highly Computerized Laboratory Operations (Withdrawn 2002)
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ASTM E1579-94 - Standard Guide for Ensuring Data Integrity in Highly Computerized Laboratory Operations (Withdrawn 2002)
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Standards Content (Sample)

Designation: E 1579 – 94
AMERICAN SOCIETY FOR TESTING AND MATERIALS
100 Barr Harbor Dr., West Conshohocken, PA 19428
Reprinted from the Annual Book of ASTM Standards. Copyright ASTM
Standard Guide for
Ensuring Data Integrity in Highly Computerized Laboratory
1
Operations
This standard is issued under the fixed designation E 1579; 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.
2
1. Scope computerized laboratories.
1.6 This standard does not purport to address all of the
1.1 This guide covers general requirements for data integ-
safety problems, if any, associated with its use. It is the
rity for computer operations in a laboratory. This guide
responsibility of the user of this standard to establish appro-
expands upon the requirements of paragraph 11.7 in Guide E
priate safety and health practices and determine the applica-
548 for those laboratories that are highly computerized and is
bility of regulatory limitations prior to use.
intended to be used in conjunction with Guide E 548 in the
assessment of testing laboratories.
2. Referenced Documents
1.2 This guide presents requirements that are generally in
2.1 ASTM Standards:
harmony with and in addition to those in Guide E 548
E 548 Guide for General Criteria Used for Evaluating
(ISO/IEC Guide 25); the paragraphs dealing with similar
3
Laboratory Competence
subjects carry similar numbers.
3
E 1187 Terminology Relating to Laboratory Accreditation
1.3 Additional requirements may be necessary for fields of
2.2 ISO Standards:
testing where the computer system(s) are integrated into the
ISO/IEC Guide 25: General Requirements for the Compe-
test methods themselves. These requirements can normally be
4
tence of Calibration and Testing Laboratories
found in the test methods.
1.4 In highly computerized laboratories, computers are
3. Terminology
increasingly being used for:
3.1 Definitions—Basic definitions are those of Terminology
1.4.1 Direct capture of data from instruments and testing
E 1178.
machines;
3.2 Definitions of Terms Specific to This Standard:
1.4.2 Automatic control and monitoring of test processes;
3.2.1 highly computerized laboratory—one in which com-
1.4.3 Control of critical environmental conditions;
puters are employed to perform almost all of the laboratory
1.4.4 Capture, processing, and display of laboratory quality-
functions (for example, as identified in 1.4) with staff merely
control data;
setting up the samples for testing and overseeing the process.
1.4.5 Basic data processing;
3.2.2 raw data—data used as input to a computerized
1.4.6 Data storage and retrieval;
operation in the laboratory: must be defined explicitly for each
1.4.7 Generation of test reports;
computer operation. Section 13 further amplifies the meaning.
1.4.8 Scheduling and monitoring of work throughput;
3.2.3 software—written instructions that, when imple-
1.4.9 Monitoring and control of inventories;
mented, cause the computer or application program to operate.
1.4.10 Equipment inventories, and calibration and mainte-
nance schedules;
4. Significance and Use
1.4.11 Design of statistical experiments; and
4.1 A laboratory is the processor and provider of informa-
1.4.12 Communication between laboratories (and with cli-
tion. Like other processors and providers of information,
ents).
laboratories are exploiting the benefits of modern information
1.5 The assessment of the highly computerized laboratory
technology.
will depend upon the nature of the computer systems and the
4.2 The assessment of a highly computerized laboratory
functions they are intended to perform. This guide may be
useful in assessing portions of computer systems in less highly
2
Older laboratory computer systems or less “highly computerized” systems in
laboratories may not be capable of conforming to the provisions of this guide due
to software or hardware limitations, or both. If conformance to this guide is
1 important to the laboratory’s operations, it may be necessary to appropriately
This guide is under the jurisdiction of ASTM Committee E-36 on Laboratory
upgrade the software or hardware, or both, before it is possible to achieve guide
and Inspection Agency Evaluation and Accreditation and is the direct responsibility
criteria.
of Subcommittee E36.10 on Genetic Criteria.
3
Annual Book of ASTM Standards, Vol 14.02.
Current edition approved Oct. 15, 1994. Published March 1999.Originally
4
Available from American National Standards Institute, 11 W. 42nd St., 13th
published as E 1579 - 93. Last previous edition E 1579 - 93.
Floor, New York, NY 10036.
1

---------------------- Page: 1 ----------------------
E 1579
using this guide will depend upon the nature of the computer audit the computer system(s) and the related test information
systems and the functions
...

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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
ASTM E2699-20(Practice)
Standard Practice for Digital Imaging and Communication in Nondestructive Evaluation (DICONDE) for Digital Radiographic (DR) Test Methods

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

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ASTM
ASTM 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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