1.1 本指南确定了用于开发和优化新的或修改的子委员会D19.05和D19.06测试方法的程序，这些测试方法用于EPA饮用水和废水项目中的法规遵从性报告。本指南还可用于制定可能尚未达到监管要求的新兴污染物的测试方法。 1.2 本指南还引用了在单实验室表征和优化以及实验室间研究（ILSs）中有用的统计程序。 1.3 以国际单位制表示的数值应视为标准值。本标准不包括其他计量单位。 1.4 本指南提供了有组织的信息收集或一系列选项，并不推荐具体的行动方案。本文件不能取代教育或经验，应与专业判断一起使用。并非本指南的所有方面都适用于所有情况。 本ASTM标准不代表或取代必须根据其判断给定专业服务的充分性的谨慎标准，也不应在不考虑项目的许多独特方面的情况下应用本文件。本文件标题中的“标准”一词仅表示该文件已通过ASTM共识程序获得批准。 1.5 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的用户有责任在使用前制定适当的安全、健康和环境实践，并确定监管限制的适用性。 1.6 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。 ====意义和用途====== 4.1 ASTM指导手册， ASTM标准的形式和样式 , 4. 第A21节要求在所有ASTM试验方法中提供精度和偏差声明。第A21.2.2节规定: 应根据实践中规定的实验室间测试程序估计精度 E691 ，进行实验室间研究以确定试验方法的精度，或通过产生等效信息的实验室间试验程序，例如，由ASTM技术委员会制定的标准实践。 4.2 实践 D2777 ，第1.1节规定: 本规程为D19水委员会适用试验方法的精度和偏差的估计和表示建立了统一标准。试验方法中的精度和偏差声明由 ASTM标准的形式和样式 ，“第A21节精度和偏差（强制性）。”原则上，本规程涵盖了所有（ASTM委员会D19）试验方法。 4.3 实践 D2777 ，第1.2节，要求一个任务组提出一种新的测试方法，以进行合作研究，从中制定浓度限值、重复性和再现性精度以及偏差声明。 4.3.1 本指南描述了为D19委员会开发和优化化学测试方法的选项，而不是由实验室实施测试方法。请参阅指南 E2857 用于验证实验室现有测试方法的程序。 4.3.2 实践中描述的协作研究 D2777 不是测试方法验证。合作研究验证了新测试方法在不同实验室、不同仪器/装置和不同分析员之间的可重复性。 4.3.3 实践 D2777 ，第6.1节，假设在进行协作研究之前已经优化了测试方法。 4.4 实践 D2777 第4节（实践总结）要求，只有在任务组确保初步评估工作已完成且测试方法已以最终形式编写后，才能进行协作研究。 4.5 实践 D2777 第5.2节（重要性和用途）要求协作测试在测试设计的限制范围内证实测试方法编写（初步评估）。 4.5.1 假设在使用测试方法分析基质和测试方法中规定的浓度范围时，协作研究是对实验室间可变性的公平评估。 4.6 实践 D2777 ，第6节（初步研究），要求在确定精度和偏差（协作研究）之前，对测试方法进行大量的试点工作。该试点工作评估了以下变量: 4.6.1 代表性采样， 4.6.2 容器的适用性， 4.6.3 保存要求， 4.6.4 干扰识别， 4.6.5 保持时间（练习 D4841 ), 4.6.6 浓度范围， 4.6.7 定量范围， 4.6.8 试剂的浓缩和制备， 4.6.9 试剂标准化， 4.6.10 试剂的保质期， 4.6.11 标定 4.6.12 QC，以及 4.6.13 样本量。 4.7 预先调查潜在的重要因素，并在为协作测试分发的书面测试方法中进行控制。 4.8 只有在提议的测试方法经过彻底的尝试和证明，并简化为明确的书面形式后，才能进行协作测试。 4.9 委员会D19试验方法分两步编写: 4.9.1 第一步- 单个实验室表征或优化（实践 D2777 ，第6.3.1.1节）。 4.9.2 第二步- 协作学习（实践 D2777 ，第6.3.1.2节）。 4.10 本文件是D19委员会工作组制定化学测试方法的指南。

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 Barriers to Trade (TBT) Committee. ====== 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 work is complete and the test method has been written in its final form. 4.5 Practice D2777 , Section 5.2 (Significance and Use), requires the collaborative test corroborates the test method write up (preliminary evaluation) within the limits of the test design. 4.5.1 The assumption is that the collaborative study is a fair evaluation of the inter-laboratory variability when using the test method to analyze the matrices, and concentration ranges specified in the test method. 4.6 Practice D2777 , Section 6 (Preliminary Studies), requires considerable pilot work on a test method should precede the determination of precision and bias (collaborative study). This pilot work evaluates such variables as: 4.6.1 Representative Sampling, 4.6.2 Suitability of containers, 4.6.3 Preservation requirements, 4.6.4 Identification of interferences, 4.6.5 Holding times (Practice D4841 ), 4.6.6 Concentration range, 4.6.7 Quantitation ranges, 4.6.8 Concentration and preparation of reagents, 4.6.9 Reagent standardization, 4.6.10 Shelf life of reagents, 4.6.11 Calibration, 4.6.12 QC, and 4.6.13 Sample size. 4.7 Potentially significant factors are investigated in advance and are controlled in the written test method that is distributed for the collaborative test. 4.8 Only after the proposed test method has been thoroughly tried and proved and reduced to unequivocal written form should a collaborative test be conducted. 4.9 The Committee D19 test method is written in two steps: 4.9.1 Step I— Single laboratory characterization or optimization (Practice D2777 , Section 6.3.1.1). 4.9.2 Step II— Collaborative study (Practice D2777 , Section 6.3.1.2). 4.10 This document is a guide to Committee D19 task groups developing chemical test methods.