1、Designation:C106815Standard Guide forQualification of Measurement Methods by a LaboratoryWithin the Nuclear Industry1This standard is issued under the fixed designation C1068;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year o
2、f 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 guide provides guidance for selecting,validating,and qualifying measurement methods when qualification isrequired fo
3、r a specific program.The recommended practicespresented in this guide provide a major part of a qualityassurance program for the laboratory data(see Fig.1).Quali-fication helps to assure that the data produced will meetestablished requirements.1.2 The activities intended to assure the quality of ana
4、lyticallaboratory measurement data are diagrammed in Fig.1.Dis-cussion and guidance related to some of these activities appearin the following sections:SectionSelection of Measurement Methods5Validation of Measurement Methods6Qualification of Measurement Methods7Control8Personnel Qualification91.3 T
5、his 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 regulatory limitations prior to use.2.Referenced Documents2
6、.1 ASTM Standards:2C859 Terminology Relating to Nuclear MaterialsC1009 Guide for Establishing and Maintaining a QualityAssurance Program forAnalytical Laboratories Within theNuclear IndustryC1128 Guide for Preparation of Working Reference Materi-als for Use in Analysis of Nuclear Fuel Cycle Material
7、sC1156 Guide for Establishing Calibration for a Measure-ment Method Used to Analyze Nuclear Fuel Cycle Mate-rialsC1210 Guide for Establishing a Measurement System Qual-ity Control Program for Analytical Chemistry Laborato-ries Within the Nuclear IndustryC1297 Guide for Qualification of Laboratory An
8、alysts forthe Analysis of Nuclear Fuel Cycle MaterialsE177 Practice for Use of the Terms Precision and Bias inASTM Test MethodsE2554 Practice for Estimating and Monitoring the Uncer-tainty of Test Results of a Test Method Using ControlChart TechniquesE2655 Guide for Reporting Uncertainty of Test Res
9、ults andUse of the Term Measurement Uncertainty in ASTM TestMethods2.2 ISO Standards:3ISO/IEC 17025 General Requirements for the Competenceof Testing and Calibration Laboratories2.3 Other Standards:ASME NQA-1 QualityAssurance Requirements for NuclearFacility Applications4IEEE/ASTM SI 10 American Nat
10、ional Standard for MetricPractice5JCGM-100 Evaluation of Measurement Data Guide to theExpression of Uncertainty in Measurement(GUM)6JCGM-200 International Vocabulary of Metrology Basicand General Concepts and Associated Terms(VIM)63.Terminology3.1 Except as otherwise defined herein,definitions of te
11、rmsare as given in Terminology C859.3.2 Definitions of Terms Specific to This Standard:1This guide is under the jurisdiction of ASTM Committee C26 on Nuclear FuelCycle and is the direct responsibility of Subcommittee C26.08 on QualityAssurance,Statistical Applications,and Reference Materials.Current
12、 edition approved June 1,2015.Published June 2015.Originallyapproved in 1986.Last previous edition approved in 2011 as C1068 03(2011).DOI:10.1520/C1068-15.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStan
13、dards volume information,refer to the standards Document Summary page onthe ASTM website.3Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.4Available from American Society of Mechanical Engineers(ASME),ASMEInternational Headquart
14、ers,Two Park Ave.,New York,NY 10016-5990,http:/www.asme.org.5Available from Institute of Electrical and Electronics Engineers,Inc.(IEEE),445 Hoes Ln.,Piscataway,NJ 08854-4141,http:/www.ieee.org.6Available from International Organization for Standardization(ISO),1,ch.dela Voie-Creuse,CP 56,CH-1211 Ge
15、neva 20,Switzerland,http:/www.iso.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.2.1 fitness for purpose,ndegree to which data producedby a measurement process enables a user to make technicallyand administratively correct decision
16、s for a stated purpose(1).73.2.2 qualificationa formal process to provide a desiredlevel of confidence that measurement methods used willproduce data suitable for their intended use.The methods mustmeet established criteria prior to use and must be used underconditions established for qualifications.3.2.3 representative sample,na sample resulting from asampling plan that can be expected to adequately reflect theproperties of interest of the parent population(1).3.2.4 validation,ninvestigation to