Standard Guide for Development and Optimization of D19 Chemical Analysis Methods Intended for EPA Compliance Reporting

SIGNIFICANCE AND USE
4.1 The ASTM guidance manual, Form and Style for ASTM Standards,4 Section A21, requires a precision and bias statement in all ASTM test methods. Section A21.2.2 states:    
Precision shall be estimated in accordance with the interlaboratory test program prescribed in Practice E691, Conducting an Interlaboratory Study to Determine the Precision of a Test Method, or by an interlaboratory test program that yields equivalent information, for example, a standard practice developed by an ASTM technical committee.  
4.2 Practice D2777, Section 1.1, states:    
This practice establishes uniform standards for estimating and expressing the precision and bias of applicable test methods for Committee D19 on Water. Statements of precision and bias in test methods are required by the Form and Style for ASTM Standards, “Section A21. Precision and Bias (Mandatory).” In principle, all (ASTM Committee D19) test methods are covered by this practice.  
4.3 Practice D2777, Section 1.2, requires a task group proposing a new test method to carry out a collaborative study from which concentration limits, repeatability and reproducibility precision and bias statements are developed.  
4.3.1 This guide describes options for developing and optimizing chemical test methods for Committee D19, not implementation of a test method by a laboratory. Refer to Guide E2857 for procedures used in validating existing test methods for your laboratory.  
4.3.2 The collaborative study described in Practice D2777 is not the test method validation. The collaborative study verifies the new test method is reproducible among different laboratories, different instruments/apparatus, and different analysts.  
4.3.3 Practice D2777, Section 6.1, assumes the test method has already been optimized prior to conducting the collaborative study.  
4.4 Practice D2777, Section 4 (Summary of Practice), requires, a collaborative study only after the task group has assured itself that preliminary evaluation ...
SCOPE
1.1 This guide identifies procedures for use in developing and optimizing new or modified Subcommitees D19.05 and D19.06 test methods intended for regulatory compliance reporting in EPA drinking water and wastewater programs. This guide may also be useful for developing test methods for emerging contaminants that may not yet have regulatory requirements.  
1.2 This guide also cites statistical procedures that are useful in the single laboratory characterization and optimization and in the inter-laboratory studies (ILSs).  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 This guide offers an organized collection of information or a series of options and does not recommend a specific course of action. This document cannot replace education or experience and should be used in conjunction with professional judgment. Not all aspects of this guide may be applicable in all circumstances. This ASTM standard is not intended to represent or replace the standard of care by which the adequacy of a given professional service must be judged, nor should this document be applied without consideration of a project’s many unique aspects. The word “Standard” in the title of this document means only that the document has been approved through the ASTM consensus process.  
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...

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Publication Date
30-Nov-2019
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ASTM D8272-19 - Standard Guide for Development and Optimization of D19 Chemical Analysis Methods Intended for EPA Compliance Reporting
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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.
Designation: D8272 − 19
Standard Guide for
Development and Optimization of D19 Chemical Analysis
1
Methods Intended for EPA Compliance Reporting
This standard is issued under the fixed designation D8272; 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 mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
1.1 This guide identifies procedures for use in developing
and optimizing new or modified Subcommitees D19.05 and
2. Referenced Documents
D19.06 test methods intended for regulatory compliance re-
2
2.1 ASTM Standards:
porting in EPA drinking water and wastewater programs. This
D1129 Terminology Relating to Water
guide may also be useful for developing test methods for
D1141 Practice for the Preparation of Substitute Ocean
emerging contaminants that may not yet have regulatory
Water
requirements.
D2777 Practice for Determination of Precision and Bias of
1.2 This guide also cites statistical procedures that are
Applicable Test Methods of Committee D19 on Water
useful in the single laboratory characterization and optimiza-
D4841 Practice for Estimation of Holding Time for Water
tion and in the inter-laboratory studies (ILSs).
Samples Containing Organic and Inorganic Constituents
1.3 The values stated in SI units are to be regarded as
D5847 Practice for Writing Quality Control Specifications
standard. No other units of measurement are included in this
for Standard Test Methods for Water Analysis
standard.
E178 Practice for Dealing With Outlying Observations
E691 Practice for Conducting an Interlaboratory Study to
1.4 This guide offers an organized collection of information
Determine the Precision of a Test Method
or a series of options and does not recommend a specific
E1169 Practice for Conducting Ruggedness Tests
course of action. This document cannot replace education or
E1488 GuideforStatisticalProcedurestoUseinDeveloping
experienceandshouldbeusedinconjunctionwithprofessional
and Applying Test Methods
judgment. Not all aspects of this guide may be applicable in all
E1601 Practice for Conducting an Interlaboratory Study to
circumstances. This ASTM standard is not intended to repre-
Evaluate the Performance of an Analytical Method
sent or replace the standard of care by which the adequacy of
E2857 Guide for Validating Analytical Methods
a given professional service must be judged, nor should this
E2935 Practice for Conducting Equivalence Testing in
document be applied without consideration of a project’s many
Laboratory Applications
unique aspects. The word “Standard” in the title of this
E3080 Practice for Regression Analysis
document means only that the document has been approved
3
2.2 Code of Federal Regulations (CFR) Standard:
through the ASTM consensus process.
1.5 This standard does not purport to address all of the 40 CFR Part 136, Appendix B Definition and Procedure for
the Determination of the Method Detection Limit
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
3. Terminology
priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use.
3.1 Definitions:
1.6 This international standard was developed in accor-
3.1.1 For definitions of terms used in this standard, refer to
dance with internationally recognized principles on standard-
Terminology D1129.
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
1
This guide is under the jurisdiction ofASTM Committee D19 on Water and is Standards volume information, refer to the standard’s Document Summary page on
thedirectresponsibilityofSubcommitteeD19.02onQualitySystems,Specification, the ASTM website.
3
and Statistics. Available from U.S. Government Printing Office, Superintendent of
Current edition approved Dec. 1, 2019. Published January 2020. DOI: 10.1520/ Documents, 732 N. Capitol St., NW, Washington, DC 20401-0001, http://
D8272-19. www.access.gpo.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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D8272 − 19
3.2 Definitions of Terms Specific to This Standard: 4.3 Practice D27
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