ASTM E2438-05
(Practice)Standard Practice for Implementing Standard Performance Based Test Methods for the Analysis of Metals, Ores, and Related Materials (Withdrawn 2014)
Standard Practice for Implementing Standard Performance Based Test Methods for the Analysis of Metals, Ores, and Related Materials (Withdrawn 2014)
SCOPE
1.1 This practice describes a model for use by analytical chemistry laboratories in implementing standard performance-based test methods, such as those developed in accordance with Practice E 2437.
1.2 The principles in these practices can also be used by ISO 17025 compliant laboratories that need to implement other performance-based test methods or need to document and validate extensions of standard test methods, or non-standard test methods.
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 and health practices and determine the applicability of regulatory limitations prior to use.
WITHDRAWN RATIONALE
This practice described a model for use by analytical chemistry laboratories in implementing standard performance-based test methods.
Formerly under the jurisdiction of Committee E01 on Analytical Chemistry for Metals, Ores, and Related Materials, this practice was withdrawn in January 2014 in accordance with section 10.6.3 of the Regulations Governing ASTM Technical Committees, which requires that standards shall be updated by the end of the eighth year since the last approval date.
General Information
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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
Designation: E2438 − 05
StandardPractice for
Implementing Standard Performance Based Test Methods
for the Analysis of Metals, Ores, and Related Materials
This standard is issued under the fixed designation E2438; 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 Scope Materials (Withdrawn 2007)
E2437 Practice for Designing and Validating Performance-
1.1 This practice describes a model for use by analytical
Based Test Methods for theAnalysis of Metals, Ores, and
chemistry laboratories in implementing standard performance-
Related Materials
based test methods, such as those developed in accordance
with Practice E2437. 2.2 ISO Standards
ISO 17025 General Requirements for the Competence of
1.2 TheprinciplesinthesepracticescanalsobeusedbyISO
Testing and Calibration Laboratories
17025 compliant laboratories that need to implement other
ISO Guide 32 Calibration in Analytical Chemistry and Use
performance-based test methods or need to document and
of Certified Reference Materials
validate extensions of standard test methods, or non-standard
ISO 5725 Precision of Test Results – Determination of
test methods.
repeatability and reproducibility by interlaboratory tests
1.3 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
3. Terminology
responsibility of the user of this standard to establish appro-
3.1 Definitions—For definitions of terms used in the
priate safety and health practices and determine the applica-
Practice, refer to Terminology E135.
bility of regulatory limitations prior to use.
3.2 Definitions of Terms Specific to This Standard:
2. Referenced Documents 3.2.1 aim total intralaboratory uncertainty, n—the maxi-
2 mum deviation (95 % confidence) to be allowed in the design
2.1 ASTM Standards:
of the total intralaboratory uncertainty of a test method,
E135 Terminology Relating to Analytical Chemistry for
beginning with the preparation of a homogeneous sample and
Metals, Ores, and Related Materials
ending with a final report value to the client.
E691 Practice for Conducting an Interlaboratory Study to
3.2.2 performance based method, n—a test method that
Determine the Precision of a Test Method
defines (1) the general approaches for sampling, sample
E1329 Practice for Verification and Use of Control Charts in
preparation, and making measurements on a specified type of
Spectrochemical Analysis
material, and, (2) defines maximum allowable uncertainties for
E1601 Practice for Conducting an Interlaboratory Study to
each measured constituent over its validated concentration
Evaluate the Performance of an Analytical Method
range.
E2027 Practice for Conducting Proficiency Tests in the
ChemicalAnalysis of Metals, Ores, and Related Materials
3.2.3 total intralaboratory uncertainty, n—in a performance
E2093 GuideforOptimizing,ControllingandAssessingTest
based standard test method, the precision (95 % confidence)
Method Uncertainties from Multiple Workstations in the
that a laboratory achieves when the method is used by more
Same Laboratory Organization
than one operator.
E2165 Practice for Establishing an Uncertainty Budget for
3.2.3.1 Discussion—In test methods that establish maxi-
the Chemical Analysis of Metals, Ores, and Related
mum allowable intralaboratory uncertainties, users must be
able to demonstrate compliance with those uncertainties in
order to report that a given test result was produced using the
This practice is under the jurisdiction of ASTM Committee E01 on Analytical
named method.
Chemistry for Metals, Ores, and Related Materials and is the direct responsibility of
Subcommittee E01.22 on Laboratory Quality.
Current edition approved May 1, 2005. Published July 2005. DOI: 10.1520/
E2438-05.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or The last approved version of this historical standard is referenced on
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM www.astm.org.
Standards volume information, refer to the standard’s Document Summary page on Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036, http://www.ansi.org.
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E2438 − 05
3.2.4 uncertainty budget, n—theallocationoftotalmeasure- comply with the standard test method, the instructions in the
ment uncertainty among specific components of a measure- SOP or referenced documents shall include all documentation
ment process that contribute significantly to the overall devia- required by the standard. In order for the laboratory to report
tion. test results based on the standard test method in accordance
with ISO 17025, it shall not violate any of the requirements in
4. Significance and Use
the standard test method. It may elect to determine fewer
analytes specified in the method and/or to calibrate its method
4.1 This practice is aimed at guiding analytical chemistry
over more-limited concentration ranges specified in the test
laboratories through the implementation of ASTM standard
method. However, if the laboratory elects to extend determined
performance-based test methods in a manner that complies
elements or concentration ranges, or both, not included in the
with ISO 17025. The principles incorporated in this practice
standard method, it must validate those extensions and report a
can also be applied in laboratories that wish to extend the
statement of variation in any test reports that refer to the
application of standard test methods beyond their published
standard test method. The form and style of the SOP is not
scopes or to validate and document non-standard methods.
prescribed; each laboratory is encouraged to incorporate the
4.2 The major responsibilities described in this practice
required documentation within its existing structure.
include (1) writing an in-house standard operating procedure
5.2 Scope—List the elements and concentration ranges, or
that describes how the laboratory carries out the test method,
grade specifications, to be included in the laboratory’s imple-
(2) developing and documenting data to demonstrate that the
mentation of the standard. Also, list the elements and concen-
laboratory can meet the data quality requirements specified in
tration ranges to be determined by the laboratory using this
the standard test method, and, (3) monitoring the quality
method. If a laboratory includes more than one similar work-
control and proficiency test data, where available, over time, to
station in an SOP, it may coordinate them as described in
ensure sustained data quality performance.
Practice E2093, provided that all data quality objectives
4.3 Someperformance-basedstandardmethodsspecifyonly
described in the standard test method are complied with. Be
intralaboratory precision, while others may include either full
sure to reference the standard test method under implementa-
or partial uncertainty budgets, with required performance
tion.
levels at each step in the procedure. Users of the standard
5.3 Apparatus—List all pieces of equipment used in the
performance-based methods are expected to comply with all
testing that might influence the quality of test results. Make
performance requirements in each method.
sure that items on the list are uniquely identified and traceable
4.4 Proficiency test programs, such as those carried out
to other related documentation such as maintenance records. If
under Practice E2027, provide interlaboratory performance
multiple workstations are used, such as described in Practice
data from large numbers of laboratories, using a vari
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