ASTM E2935-2016 Standard Practice for Conducting Equivalence Testing in Laboratory Applications《实验室设施中进行等效性试验的标准实施规程》.pdf
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1、Designation: E2935 16 An American National StandardStandard Practice forConducting Equivalence Testing in Laboratory Applications1This standard is issued under the fixed designation E2935; 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 provides statistical methodology for con-ducting equivalence testing on numerical data
3、 from twosources to determine if their true means or variances differ byno more than predetermined limits.1.2 Applications include (1) equivalence testing for biasagainst an accepted reference value, (2) determining meansequivalence of two test methods, test apparatus, instruments,reagent sources, o
4、r operators within a laboratory or equiva-lence of two laboratories in a method transfer, and (3)determining non-inferiority of a modified test procedure versusa current test procedure with respect to a performance charac-teristic.1.3 The guidance in this standard applies only to experi-ments conduc
5、ted on a single material at a given level of the testresult.1.4 Guidance is given for determining the amount of datarequired for an equivalence trial. The control of risks associ-ated with the equivalence decision is discussed.1.5 The values stated in SI units are to be regarded asstandard. No other
6、 units of measurement are included in thisstandard.1.6 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of
7、regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2E177 Practice for Use of the Terms Precision and Bias inASTM Test MethodsE456 Terminology Relating to Quality and StatisticsE2282 Guide for Defining the Test Result of a Test MethodE2586 Practice for Calculating and Using
8、 Basic Statistics2.2 USP Standard:3USP Validation of Alternative MicrobiologicalMethods3. Terminology3.1 DefinitionsSee Terminology E456 for a more exten-sive listing of statistical terms.3.1.1 accepted reference value, na value that serves as anagreed-upon reference for comparison, and which is der
9、ivedas: (1) a theoretical or established value, based on scientificprinciples, (2) an assigned or certified value, based on experi-mental work of some national or international organization, or(3) a consensus or certified value, based on collaborativeexperimental work under the auspices of a scienti
10、fic orengineering group. E1773.1.2 bias, nthe difference between the expectation of thetest results and an accepted reference value. E1773.1.3 confidence interval, nan interval estimate L, Uwith the statistics L and U as limits for the parameter andwith confidence level 1 , where Pr(L U) 1 . E25863.
11、1.3.1 DiscussionThe confidence level, 1 , reflects theproportion of cases that the confidence interval L, U wouldcontain or cover the true parameter value in a series of repeatedrandom samples under identical conditions. Once L and U aregiven values, the resulting confidence interval either does ord
12、oes not contain it. In this sense “confidence” applies not to theparticular interval but only to the long run proportion of caseswhen repeating the procedure many times.3.1.4 confidence level, nthe value, 1 , of the probabilityassociated with a confidence interval, often expressed as apercentage. E2
13、5863.1.4.1 Discussion is generally a small number. Confi-dence level is often 95 % or 99 %.3.1.5 confidence limit, neach of the limits, L and U, of aconfidence interval, or the limit of a one-sided confidenceinterval. E25861This test method is under the jurisdiction of ASTM Committee E11 on Qualitya
14、nd Statistics and is the direct responsibility of Subcommittee E11.20 on TestMethod Evaluation and Quality Control.Current edition approved Nov. 15, 2016. Published January 2017. Originallyapproved in 2013. Last previous edition approved in 2015 as E2935 15. DOI:10.1520/E2935-16.2For referenced ASTM
15、 standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.3Available from U.S. Pharmacopeial Convention (USP), 12601 TwinbrookPkwy., Rockvi
16、lle, MD 20852-1790, http:/www.usp.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on
17、Principles for theDevelopment of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.13.1.6 degrees of freedom, nthe number of independentdata points minus the number of parameters that have to beestimated before calc
18、ulating the variance. E25863.1.7 equivalence, ncondition that two population param-eters differ by no more than predetermined limits.3.1.8 intermediate precision conditions, nconditions un-der which test results are obtained with the same test methodusing test units or test specimens taken at random
19、 from a singlequantity of material that is as nearly homogeneous as possible,and with changing conditions such as operator, measuringequipment, location within the laboratory, and time. E1773.1.9 mean, nof a population, , average or expectedvalue of a characteristic in a population of a sample, Xsum
20、of the observed values in the sample divided by the samplesize. E25863.1.10 percentile, nquantile of a sample or a population,for which the fraction less than or equal to the value isexpressed as a percentage. E25863.1.11 population, nthe totality of items or units ofmaterial under consideration. E2
21、5863.1.12 population parameter, nsummary measure of thevalues of some characteristic of a population. E25863.1.13 precision, nthe closeness of agreement betweenindependent test results obtained under stipulated conditions.E1773.1.14 quantile, nvalue such that a fraction f of the sampleor population
22、is less than or equal to that value. E25863.1.15 repeatability, nprecision under repeatabilityconditions. E1773.1.16 repeatability conditions, nconditions where inde-pendent test results are obtained with the same method onidentical test items in the same laboratory by the same operatorusing the sam
23、e equipment within short intervals of time. E1773.1.17 repeatability standard deviation (sr), nthe standarddeviation of test results obtained under repeatabilityconditions. E1773.1.18 sample, na group of observations or test results,taken from a larger collection of observations or test results,whic
24、h serves to provide information that may be used as a basisfor making a decision concerning the larger collection. E25863.1.19 sample size, n, nnumber of observed values in thesample. E25863.1.20 sample statistic, nsummary measure of the ob-served values of a sample. E25863.1.21 standard deviationof
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