ASTM D2777-21 PDF
Standard Practice for Determination of Precision and Bias of Applicable Test Methods of Committee D19 on Water
Standard Practice for Determination of Precision and Bias of Applicable Test Methods of Committee D19 on Water
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 21
- Дата публикации:
- 15 декабря 2021 г.
- Издание:
- D2777
- ICS:
- 13.060.50
SIGNIFICANCE AND USE 5.1 Following this practice should result in precision-and-bias statements that can be achieved by any laboratory properly using the test method studied. These precision-and-bias statements provide the basis for generic limits for use in the Quality Control section of the test method. Optionally, the detection and quantitation values provide estimates of the level at which most laboratories should be able to achieve confident detection and meet the minimum precision (expressed as relative standard deviation) expected. 5.2 The method specifies the matrices for which the test method is appropriate. The collaborative test corroborates the write-up within the limitations of the test design. An extensive test can only use representative matrices so that universal applicability cannot be implied from the results. 5.3 The fundamental assumption of the collaborative study is that the matrices tested, the concentrations tested, and the participating laboratories are a representative and fair evaluation of the scope and applicability of the test method as written. SCOPE 1.1 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 test methods are covered by this practice. However, the variability equations provided in this standard are applicable only to test methods that yield continuous function values. 1.2 Except as specified in 1.4, 1.5, and 1.6, this practice requires the task group proposing a new test method to carry out a collaborative study from which statements for precision (overall and single-operator standard-deviation estimates) and bias can be developed. This practice provides general guidance to task groups in planning and conducting such determinations of precision and bias. 1.3 This practice requires that a task group making a substantive revision to a test method also perform a limited-scale collaborative study (known as a ― comparability study) to evaluate the effect of the revision on the precision and bias statement. This practice provides guidance to task groups for conducting such limited-scale collaborative studies. Examples of substantive modifications may include, but are not limited to, changes in mandatory or allowable instrumentation, reagents, reaction times, etc. 1.3.1 Changes to applicable water matrices in the Scope of a method may constitute a substantive modification under this provision. Only matrices that have been evaluated in an approved collaborative study may be listed in the Scope of a method. It is recognized that the term “matrix” is generally vague. Terms specifying matrix types can cover significantly different chemical constituents, unless the matrix is synthesized to be of a standardized makeup. Substitute Wastewater (Practice D5905) is one such defined matrix. For purposes of this practice, the importance of this requirement is to assist the user of a D19 standard in determining the applicability of the method to their samples. Evaluated matrices should be described with as much detail as possible to minimize misapplication. 1.3.2 A method's concentration-range extension that is deemed to merit additional collaborative testing (even without a method modification that would otherwise be considered substantive) shall require a full collaborative study, as described in 7.1 through 7.5, but only at concentrations representative of the extended range. Note that such a collaborative study could involve as little as a single concentration study in a single reproducible matrix. 1.3.3 Whether a revision to a test method includes substantive modification shall be determined by consensus of the Committee. 1.4 If a full-scale collaborative study is not technically feasible, because...
Abstract
Overview
ASTM D2777-21, “Standard Practice for Determination of Precision and Bias of Applicable Test Methods of Committee D19 on Water,” establishes uniform guidelines for assessing and expressing the precision and bias of analytical test methods used in water analysis. Developed by ASTM Committee D19 on Water, this standard practice is crucial for laboratories and organizations involved in water quality measurement, ensuring that test results are both reliable and comparable across different laboratories and applications.
ASTM D2777-21 provides the framework required for developing and updating standardized test methods and supports quality control processes through defined collaborative studies. The practice covers the planning, execution, and statistical evaluation of precision and bias, enabling test method users and developers to generate meaningful statements of method performance.
Key Topics
- Precision and Bias Evaluation: The standard details procedures to estimate and report the precision (repeatability and reproducibility) and bias of water testing methods.
- Collaborative Studies: Provides protocols for interlaboratory studies that form the basis for precision and bias statements in test method documentation.
- Quality Control Integration: The results guide the creation of generic quality control limits used in standardized water test methods.
- Applicability of Matrices: Discusses the importance of clearly specifying water sample matrices applicable to a given method, based on the collaborative studies performed.
- Substantive Method Changes: Outlines requirements for comparability or validation studies when test methods undergo significant modification, such as changes in reagents, instrumentation, or sample type.
- Minimum Requirements: Sets minimum participation thresholds for laboratories and operators to ensure statistically valid outcomes for precision and bias estimates.
- Types of Evaluations: Supports development of statements for methods that yield numerical and non-numerical results, including procedures referencing other standards.
Applications
ASTM D2777-21 plays a pivotal role for:
- Analytical Laboratories: Assisting in the development and validation of new water analysis methods, and in maintaining accreditation through reliable, comparable test results.
- Test Method Development: Guiding task groups in planning robust collaborative and comparability studies for both new and substantively revised water test methods.
- Regulatory Compliance: Supporting the establishment of quality control procedures and performance specifications, often required for regulatory approval and reporting.
- Water Quality Assurance: Ensuring water analysis results, such as those produced by municipal, industrial, or environmental laboratories, are precise, unbiased, and consistent.
- Standard Revisions: Mandating that substantive updates to test methods (e.g., concentration ranges or matrix modifications) are accompanied by appropriate re-evaluations of method performance.
By establishing clear protocols for multi-laboratory studies, ASTM D2777-21 helps organizations build confidence in their analytical data, minimize misapplication of methods to inappropriate matrices, and meet international standards for test method validation.
Related Standards
ASTM D2777-21 references and is complemented by several related ASTM standards, including:
- ASTM D1129: Terminology Relating to Water
- ASTM D1193: Specification for Reagent Water
- ASTM D1141: Practice for Preparation of Substitute Ocean Water
- ASTM D5905: Practice for Preparation of Substitute Wastewater
- ASTM D5847: Practice for Writing Quality Control Specifications for Water Analysis
- ASTM D6091: Practice for 99%/95% Interlaboratory Detection Estimate (IDE)
- ASTM D6512: Practice for Interlaboratory Quantitation Estimate
- ASTM E177: Practice for Use of the Terms Precision and Bias in ASTM Test Methods
- ASTM E691: Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method
Together, these standards support robust water analysis and ensure alignment with global best practices for laboratory quality assurance and method validation.
ASTM D2777-21 is critical for any organization striving for consistent, transparent, and high-quality water testing outcomes.
Технические детали
- Технический комитет
- D19 - Water
- SKU
- ASTM D2777-21
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