欢迎来到麦多课文档分享! | 帮助中心 海量文档,免费浏览,给你所需,享你所想!
麦多课文档分享
全部分类
  • 标准规范>
  • 教学课件>
  • 考试资料>
  • 办公文档>
  • 学术论文>
  • 行业资料>
  • 易语言源码>
  • ImageVerifierCode 换一换
    首页 麦多课文档分享 > 资源分类 > PDF文档下载
    分享到微信 分享到微博 分享到QQ空间

    ASTM D2777-2013 Standard Practice for Determination of Precision and Bias of Applicable Test Methods of Committee D19 on Water《D19水委员会对水适用试验方法的精确性及偏差测定的标准操作规程》.pdf

    • 资源ID:513484       资源大小:202.69KB        全文页数:21页
    • 资源格式: PDF        下载积分:10000积分
    快捷下载 游客一键下载
    账号登录下载
    微信登录下载
    二维码
    微信扫一扫登录
    下载资源需要10000积分(如需开发票,请勿充值!)
    邮箱/手机:
    温馨提示:
    如需开发票,请勿充值!快捷下载时,用户名和密码都是您填写的邮箱或者手机号,方便查询和重复下载(系统自动生成)。
    如需开发票,请勿充值!如填写123,账号就是123,密码也是123。
    支付方式: 支付宝扫码支付    微信扫码支付   
    验证码:   换一换

    加入VIP,交流精品资源
     
    账号:
    密码:
    验证码:   换一换
      忘记密码?
        
    友情提示
    2、PDF文件下载后,可能会被浏览器默认打开,此种情况可以点击浏览器菜单,保存网页到桌面,就可以正常下载了。
    3、本站不支持迅雷下载,请使用电脑自带的IE浏览器,或者360浏览器、谷歌浏览器下载即可。
    4、本站资源下载后的文档和图纸-无水印,预览文档经过压缩,下载后原文更清晰。
    5、试题试卷类文档,如果标题没有明确说明有答案则都视为没有答案,请知晓。

    ASTM D2777-2013 Standard Practice for Determination of Precision and Bias of Applicable Test Methods of Committee D19 on Water《D19水委员会对水适用试验方法的精确性及偏差测定的标准操作规程》.pdf

    1、Designation: D2777 13Standard Practice forDetermination of Precision and Bias of Applicable TestMethods of Committee D19 on Water1This standard is issued under the fixed designation D2777; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revi

    2、sion, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This practice establishes uniform standards for estimat-ing and expressing the precision and bias of

    3、 applicable testmethods for Committee D19 on Water. Statements of precisionand bias in test methods are required by the Form and Style forASTM Standards, “Section A21. Precision and Bias (Manda-tory).” In principle, all test methods are covered by thispractice.1.2 Except as specified in 1.4, 1.5, an

    4、d 1.6, this practicerequires the task group proposing a new test method to carryout a collaborative study from which statements for precision(overall and single-operator standard-deviation estimates) andbias can be developed. This practice provides general guidanceto task groups in planning and cond

    5、ucting such determinationsof precision and bias.1.3 This practice also provides guidance to task groups forconducting limited-scale collaborative studies (known as“comparability studies”) for test methods that have beenrevised, when such revision includes substantive modifications.Examples of substa

    6、ntive modifications may include, but are notlimited to, changes in mandatory or allowable instrumentation,reagents, reaction times, etc.1.3.1 Changes to applicable water matrices in the Scope ofa method may constitute a substantive modification under thisprovision. However, recognize that even the o

    7、riginal collab-orative study may not have used all the various matrix typesspecified in the methods original Scope.1.3.2 A methods concentration-range extension that isdeemed to merit additional collaborative testing (even withouta method modification that would otherwise be consideredsubstantive) s

    8、hall require a full collaborative study, as de-scribed in Sections 7.1-7.5, but only at Youden-pair concen-trations representative of the extended range. Note that such acollaborative study could involve as little as a single-sampleYouden-pair study in a single reproducible matrix.1.3.3 Whether a re

    9、vision to a test method includes substan-tive modification shall be determined by consensus of theCommittee.1.4 If a full-scale collaborative study is not technicallyfeasible, due to the nature of the test method or instability ofsamples, the largest feasible scaled-down collaborative studyshall be

    10、conducted to provide the best possible limited basis forestimating the overall and single-operator standard deviations.1.4.1 Examples of acceptable scaled-down studies are thelocal-area studies conducted by Subcommittee D19.24 onmicrobiological methods because of inherent sample instabil-ity. These

    11、studies involve six or more completely independentlocal-area analysts who can begin analysis of uniform samplesat an agreed upon time.1.4.2 If uniform samples are not feasible under anycircumstances, a statement of single-operator precision willmeet the requirements of this practice. Whenever possib

    12、le, thisstatement should be developed from data generated by inde-pendent multiple operators, each doing replicate analyses onindependent samples (of a specific matrix type), which gener-ally fall within specified concentration ranges (see 7.2.5.2 (3).1.4.3 This practice is not applicable to methodo

    13、logy involv-ing continuous sampling or continuous measurement, or both,of specific constituents and properties.1.4.4 This practice is also not applicable to open-channelflow measurements.1.5 A collaborative study that satisfied the requirements ofthe version of this practice in force when the study

    14、wasconducted will continue to be considered an adequate basis forthe precision-and-bias statement required in each test method.If the study does not satisfy the current minimum requirementsfor a collaborative study, a statement listing the studysdeficiencies and a reference to this paragraph shall b

    15、e includedin the precision-and-bias statement as the basis for an exemp-tion from the current requirements.1.6 This paragraph relates to special exemptions not clearlyacceptable under 1.4 or 1.5. With the approval of CommitteeD19 on the recommendation of the Results Advisor and theTechnical Operatio

    16、ns Section of the Executive Subcommitteeof Committee D19, a statement giving a compelling reasonwhy compliance with all or specific points of this practice1This practice is under the jurisdiction of ASTM Committee D19 on Water andis the direct responsibility of Subcommittee D19.02 on Quality Systems

    17、,Specification, and Statistics.Current edition approved Jan. 1, 2013. Published February 2013. Originallyapproved in 1969. Last previous edition approved in 2012 as D2777 12. DOI:10.1520/D2777-13.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. Unit

    18、ed States1cannot be achieved will meet both ASTM requirements (1)2and the related requirements of this practice. In addition,Committee D19, through a Main Committee ballot, mayapprove publication of a “Preliminary” Standard Method for aperiod not to exceed 5 years. Preliminary Standards mustcontain

    19、a minimum of a single-operator precision-and-biasstatement and a Quality Control section based on the singleoperator data. Publication of a Preliminary Standard is condi-tional on the approval of a full D2777 collaborative studydesign for the standard. Precision-and-bias statements autho-rized by th

    20、is paragraph shall include the date of approval byCommittee D19.1.7 Per Section A21.2.3 of the ASTM Form and StyleManual the committee may delay an interlaboratory study fora new method and include a temporary statement in thePrecision and Bias Section that addresses only single operatorprecision (“

    21、repeatability”). This statement is valid for fiveyears from the initial publication date. In this case, a singlelaboratory study shall be conducted in accordance with Section7.6.1.8 In Section 12 this practice shows exemplary precision-and-bias-statement formats for: (1) test methods yielding anumer

    22、ical measure, (2) test methods yielding a non-numericalreport of success or failure based on criteria specified in theprocedure, and (3) test methods specifying that procedures inanother ASTM test method are to be used with only insignifi-cant modifications.1.9 All studies, even those exempt from so

    23、me requirementsunder Sections 1.4 through 1.8, shall receive approval from theResults Advisor before being conducted (see Section 8) andafter completion (see Section 13).1.10 This practice satisfies the QC requirements of PracticeD5847.1.11 It is the intent of this practice that task groups makeever

    24、y effort to retain all the data from their round-robin studies.Values should not be eliminated unless solid evidence exists fortheir exclusion. The Results Advisor should work closely withthe task groups to effect this goal.2. Referenced Documents2.1 ASTM Standards:3D1129 Terminology Relating to Wat

    25、erD1141 Practice for the Preparation of Substitute OceanWaterD1193 Specification for Reagent WaterD4375 Practice for Basic Statistics in Committee D19 onWaterD5790 Test Method for Measurement of Purgeable OrganicCompounds in Water by Capillary Column GasChromatography/Mass SpectrometryD5847 Practice

    26、 for Writing Quality Control Specificationsfor Standard Test Methods for Water AnalysisD5905 Practice for the Preparation of Substitute WastewaterD6091 Practice for 99a?%/95a?% Interlaboratory Detec-tion Estimate (IDE) for Analytical Methods with Negli-gible Calibration ErrorD6512 Practice for Inter

    27、laboratory Quantitation EstimateE177 Practice for Use of the Terms Precision and Bias inASTM Test MethodsE178 Practice for Dealing With Outlying ObservationsE456 Terminology Relating to Quality and StatisticsE691 Practice for Conducting an Interlaboratory Study toDetermine the Precision of a Test Me

    28、thodE1169 Practice for Conducting Ruggedness Tests2.2 ASTM Adjuncts:DQCALC Microsoft Excel-based software for the Interlabo-ratory Quantitation Estimate (IQE)43. Terminology3.1 DefinitionsFor definitions of terms used in thispractice, refer to Terminologies D1129, D4375 and E456, andPractice E177.3.

    29、2 Definitions of Terms Specific to This Standard:3.2.1 accuracy, na measure of the degree of conformityof a single test result generated by a specific procedure to theassumed or accepted true value, and includes both precisionand bias.3.2.2 bias, nthe persistent positive or negative deviationof the

    30、average value of a test method from the assumed oraccepted true value.3.2.3 comparability study, na collaborative study thatincorporates side-by-side evaluation of the test method beforeand after a substantive modification to a test method.3.2.4 degrees of freedom, nthe total number of replicatesana

    31、lyzed across all laboratories/analysts minus the number oflaboratories/analysts.3.2.5 laboratory, na single and completely independentanalytical system with its own specific apparatus, source ofreagents, set of internal standard-operating procedures, etc.3.2.5.1 DiscussionDifferent laboratories will

    32、 differ fromeach other in all of these aspects, regardless of how physicallyor organizationally close they may be to each other.3.2.6 limited validation study, nin a test method, a vali-dation study that does not fulfill all D2777 requirements for afull-scale collaborative study, but that can be use

    33、d for re-validation of revised methods.3.2.7 operator, nusually the individual analyst within eachlaboratory who performs the test method throughout thecollaborative study.3.2.7.1 DiscussionHowever, for complicated testmethods, the operator may be a team of individuals, eachperforming a specific fun

    34、ction throughout the study.3.2.8 precision, nthe degree of agreement of repeatedmeasurements of the same property, expressed in terms of2The boldface numbers in parentheses refer to the list of standards at the end ofthis practice.3For referenced ASTM standards, visit the ASTM website, www.astm.org,

    35、 orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.4Available from ASTM International Headquarters. Order Adjunct No.ADJDQ-CALC. Original adjunct produced in 2007.D2777 132dispersio

    36、n of test results about the arithmetical-mean resultobtained by repetitive testing of a homogeneous sample underspecified conditions.3.2.8.1 DiscussionThe precision of a test method is ex-pressed quantitatively as the standard deviation computed fromthe results of a series of controlled determinatio

    37、ns.3.2.9 substantive modification, nin a test method, achange (or changes) that is deemed by the Committee to be ofsuch magnitude that the change might affect the precision-and-bias data published with the original method.3.3 Acronyms3.3.1 MDL, nmethod detection limit4. Summary of Practice4.1 After

    38、the task group has assured itself that the testmethod has had all preliminary evaluation work completed, thetask group should prepare the test-method write-up in finalform. The plan for collaborative study is developed in accor-dance with this practice and submitted along with the test-method write-

    39、up to the Results Advisor for concurrence exceptas specified in 1.4, 1.5, and 1.6. Upon receipt of concurrence,the collaborative test is conducted, data analyzed, andprecision-and-bias statements formulated by the task group.Estimates of the lower limits of quantitation and detection mayalso be deve

    40、loped. The final precision-and-bias statistics mustbe based on usable data from at least six independent labora-tories. The statements, with backup data including thereported-results summary, the calculations leading up to thestatements, and the test method write-up with precision-and-bias statement

    41、s included are submitted to the subcommitteevice-chairman, who in turn sends a copy to the ResultsAdvisorfor concurrence before balloting. This procedure assures hav-ing an acceptable copy of the collaborative-study results tosend toASTM for items on the main-committee ballot. In mostinstances, the

    42、collaborative study shall be complete before asubcommittee ballot. If the collaborative study is not complete,the test method may go on the ballot as a provisional testmethod rather than a standard test method. Copies of the testdata, approved calculations, and statistical results shall be filedat A

    43、STM Headquarters when the test method is submitted bythe subcommittee chairman as an item for the main-committeeballot.4.1.1 The appendix shows an example of “FormAApproval of Plans for Interlaboratory Testing,” as Fig.X1.1.4.1.2 For examples of data-reporting forms, see AppendixX3, 6.0.4.1.3 In add

    44、ition, the appendix shows a sample calculationof precision and bias from real collaborative-test data, therelated table of statistics, and the related precision-and-biasstatement.5. Significance and Use5.1 Following this practice should result in precision-and-bias statements that can be achieved by

    45、 any laboratory properlyusing the test method studied. These precision-and-bias state-ments provide the basis for generic limits for use in the QualityControl section of the test method. Optionally, the detectionand quantitation values provide estimates of the level at whichmost laboratories should

    46、be able to achieve confident detectionand meet the minimum precision (expressed as relative stan-dard deviation) expected.5.2 The method specifies the matrices for which the testmethod is appropriate. The collaborative test corroborates thewrite-up within the limitations of the test design. An exten

    47、sivetest can only use representative matrices so that universalapplicability cannot be implied from the results.5.3 The fundamental assumption of the collaborative studyis that the matrices tested, the concentrations tested, and theparticipating laboratories are a representative and fair evalua-tion

    48、 of the scope and applicability of the test method as written.6. Preliminary Studies6.1 Considerable pilot work on a test method must precedethe determination of its precision and bias (2, 3). This pilotwork should explore such variables as preservationrequirements, reaction time, concentration of r

    49、eagents,interferences, calibration, and sample size. Potentially signifi-cant factors must be investigated and controlled in the writtentest method in advance of the collaborative test.Also, disregardof such factors may introduce so much variation amongoperators that results are misleading or inconclusive (4) (see9.3 and 9.4). A ruggedness study conducted in a singlelaboratory is particularly useful for such investigations andshould be conducted to prove a test method is ready forinterlaboratory testing (see Guide E1169 for details).6.2 Only after a proposed te


    注意事项

    本文(ASTM D2777-2013 Standard Practice for Determination of Precision and Bias of Applicable Test Methods of Committee D19 on Water《D19水委员会对水适用试验方法的精确性及偏差测定的标准操作规程》.pdf)为本站会员(eveningprove235)主动上传,麦多课文档分享仅提供信息存储空间,仅对用户上传内容的表现方式做保护处理,对上载内容本身不做任何修改或编辑。 若此文所含内容侵犯了您的版权或隐私,请立即通知麦多课文档分享(点击联系客服),我们立即给予删除!




    关于我们 - 网站声明 - 网站地图 - 资源地图 - 友情链接 - 网站客服 - 联系我们

    copyright@ 2008-2019 麦多课文库(www.mydoc123.com)网站版权所有
    备案/许可证编号:苏ICP备17064731号-1 

    收起
    展开