仪器确认-附件8-天平确认-中英文

1、ANNEX8OFTHEOMCLNETWORKGUIDELINEQUALIFICATIONOFEQUIPMENT仪器确认QUALIFICATIONOFBALANCES天平的确认1.INTRODUCTION介绍Thisdocumentisthe8thAnnextothecoredocumentQualificationofEquipment,whichtogethershouldbeusedwhenplanning,performinganddocumentingthequalificationprocessofbalances.本文件是核心文件仪器的确认第8个附件，在计划、实施和记录天平的确认过

2、程时，应将本文件与核心文件一起使用。ThecoredocumentcontainstheintroductionandgeneralformsforLevelIandIIofqualification,whicharecommontoalltypesofinstruments.核心文件包括了第一级和第二级确认的介绍和通用表格，适用于所有类型的仪器。Annex8containsinstrument-relatedrecommendationsonparameterstobecheckedatLevelIIIandIVofqualificationandthecorrespondingtypica

3、lacceptancelimits,aswellaspracticalexamplesonthemethodologythatcanbeusedtocarryoutthesechecks.附件8包括了仪器相关的的推荐：在第三级和第四级确认中需要检查的参数和对应的典型的可接受标准，以及可用于进行这些检查的实用方法学举例。AIMANDSCOPEOFTHEGUIDELINE目的和范围Thisguidelinedescribestherequirementsforbalances(electronic-digital)usedinchemicalandbiologicaltestsinOMCLs.本指

4、南描述了用于OMCLs化学和生物测试所用天平的要求(电子-数字)。Thefollowingtypesofbalancesareconsideredinthisguideline(Table1):本指南中涉及的天平类型包括(表1)：Table1Type类型Ordinaryname名称Numberofdigitsafterdecimalposition(g)天平分度值AccuracyClass准确度等级1.UltraMicroBalances超微量天平7I2.MicroBalances微量天平6I3.Semi-microBalances半微量天平5I4.AnalyticalBalances分析天平

5、4I5.PrecisionBalances精密天平1to3II6.TechnicalBalances技术天平0to1mTheclassificationsarebasedontheOIMLR76-1InternationalRecommendationdocument(seeTable2).该分类基于OIMLR76-1国际推荐的文件(见表2)Table2:Theverificationscaleinterval,numberofverificationscaleintervalsandminimumcapacityinrelationtotheaccuracyclassofaninstrume

6、nt.表2：检定分度值，检定分度数和与仪器准确度级别相关的最小称量Accuracyclass准确度级Verificationscaleinterval(e)检定分度值(e)Numberofverificationscaleintervals(n=Max/e)检定分度数MinimumCapacity(Min)别MinimumMaximum(Lowerlimit)最小最大最小称量Special0.001ge(Itisnotnormallyfeasibletotestandverifyaninstrumenttoe1Itisnotnormallyfeasibletotestandverifyanin

7、strumenttoe1mgduetotheuncertaintyofthetestloads.由于测量负荷的不确定度，测试和确认e1mg的仪器通常是不可行的。50000(ForaninstrumentofclassIwithd0.1mg,nForaninstrumentofclassIwithd0.1mg,nmaybelessthan50000.Theminimumcapacityisreducedto5eforgradinginstruments,i.e.instrumentsthatdetermineatransporttariffortoll(eg.postalscalesandins

8、trumentsweighingwastematerial).对于具有d0.1mg的一级仪器，n可能小于50000,对于仪器的定级最小称量值减小到5e，即用于确定运输关税或过路费(例如：邮政磅秤和称量废料的仪器)。Onmultiplerangeinstruments,theverificationscaleintervalsaree1,e2,erwithe1e2er.Similarsub-scriptsarealsousedwiththetermsMin,nandMax.多量程仪器，检定分度值分别用e1,e2,er表示，其中e1e2er。术语Min,n和Max也使用类似的脚标。Onmultip

9、lerangeinstruments,eachrangeistreatedasifitwereaninstrumentwithonerange.多量程仪器，每个量程均应按照单量程仪器处理。Forspecialapplicationsthatareclearlymarkedontheinstrument,aninstrumentmayhaveweighingrangesinclassesIandII,orinclassesIIandIII.Theinstrumentasawholeshallthencomplywiththemoresevererequirementsof3.9Variation

10、sdueto100eI特种High0.001ge0.05g10010000020eII高0.1ge500010000050eMedium0.1ge2g1001000020em中5ge5001000020eOrdinary5ge100100010em普通influencequantitiesandtimeapplicabletoeitherofthetwoclasses(seeOIMLR76-1InternationalRecommendationdocument)对于仪器上清楚标识的特殊用途，仪器可能有一级和二级或者三级和四级的称量范围。将仪器作为一个整体并符合更严格的要求，3.9由于影响量和

11、时间引起的变化(参见OIMLR76-1国际推荐文件)适用于两种情况。Max=Maximumcapacityofthebalance天平的最大量程e=verificationscaleinterval检定分度值e1,ei,er=verificationscaleinterval,rulesforindices检定分度值，索弓1规定CONSIDERATIONSFORLEVELIANDIIOFEQUIPMENTQUALIFICATION一级和二级设备确认的注意事项AtLevelIofthequalificationofbalances(selectionofinstrumentsandsupplie

12、rs),itisrecommendedtoselectamanufacturerofbalancesthatcansatisfytheneedsofthelaboratoryandworksunderISO9001certification.天平的一级确认(仪器和供应商选择)，推荐选择能够满足实验室需要和通过ISO9001认证的天平生产商。AtLevelIIofthequalificationofbalances(installationandreleaseforuse),itisrecommendedtocheckalltherequirementssetduringtheselection

13、oftheinstrumentandcalibrationshouldbeperformedbeforeputtingintoservicebyanaccreditedexternalservicesupplier,orinternallybyappropriatelyqualifiedpersonnel,usingcertifiedreferenceweightsaccordingtoanapprovedprocedure.天平的二级确认(安装和放行使用)，推荐检查在选择仪器时设定的所有要求，在投入使用前应由官方认可的外部服务提供商进行校准，或者由内部具有合适资质的人员使用标准砝码按照批准的

14、程序进行校准。REQUIREMENTSFORBALANCEUSE天平使用的要求LocationoftheBalance位置Theaccuracyandprecisionofweighingresultsarecloselyassociatedwiththelocationofthebalance.OMCLsshouldensurethatthebalancecanworkunderoptimalconditions(weighingroom/laboratory,weighingbench,temperature,light,air,etc.).称量结果的准确度和精确度与天平的放置位置密切相关

15、。OMCLs应该确保天平始终工作在最佳状态（称量间/实验室，称量台，温度，光线，空气等）。Itisrecommendedthatbalancesoftypes1to6(seeTable1above)arelocatedinaspeciallydesignedweighingroomthatisvibration-proof,dust-freeandhasananti-staticfloor.Forsubstancesthataresensibletostaticelectricityitisalsopossibletouseanionisingunit.类型16的天平(见上述表1)推荐放置在专

16、门设计的防振动、无尘、拥有防静电地板的称量室中。对于易产生静电的物质也可以使用电离单元。Ifabalanceoftype1to6islocatedinalaboratoryoutsideoftheweighingroom,thentheweighingbenchonwhichitisplacedshouldbeinaseparatepartofthelaboratorythatisvibration-proofanddust-free.Forbalancesoftypes1to4,astablebenchshouldbeused.如果类型16的天平被置于称量室外的实验室中使用时，则应将其放在位

17、于实验室中一个相对独立区域的称量台上，防振动且无尘。对于类型14的天平应该使用稳定的称量台。Itshouldbeensuredthattheweighingbenchisstable,nomatterfromwhatmaterialitismade.Theweighingbenchshouldnotdeformwhenworkiscarriedoutonitanditmustbevibration-prooforthetransferofvibrationsmustnotinfluencetheweighingprocess.Ifthereisariskofinstability,thebal

18、anceshouldbeequippedwithastabilityindicatorsothattheweightisonlyregisteredorprintedafterstabilisationofthebalance.无论用什么材质，都必须保证称量台稳固。在上面进行称量操作时，称量台不能变形，必须防振或者在转移振动时绝不能影响称量过程。如果存在不稳定风险，则天平必须装备稳定性指示器，只有天平处于稳定状态才能记录或打印称量值。Theweighingbenchshouldbenon-magnetic(i.e.nosteelplates)andprotectedagainstelectro

19、staticcharges(noplasticorglass).称量台应该不具有磁性(即非铁材料)且防静电(非塑料或玻璃材质)。Temperature温度Asweighingresultsareinfluencedbytemperature,OMCLsshouldensureaconstanttemperatureismaintainedinweighingrooms/laboratories.Thetypicaldriftofbalancesoftypes1and2is1-2ppm/C.Thedeviationshouldnotexceedmorethan5Cperhour.称量结果受到温度

20、影响时，OMCLs应该确保称量室/实验室的温度恒定。典型的温度漂移值类型1和2的天平是：12ppm/C。偏差每小时不得超过5C。Atmospherichumidity空气湿度Theoptimumrelativehumidity(%RH)duringaweighingprocessisbetween40%to60%forbalancesofclasslandII(seeTable1).Therelativehumiditymaybeexpandedto20%to80%incaseswheretheaccuracyandlinearityofmeasurementsarenotaffected.称

21、量过程第I级和第II级天平(见表1)的最佳相对湿度(RH)是40%60%。当相对湿度范围扩展到20%80%时，测量的准确度和线性可以不受影响(小于20%RH或大于80%RH，请勿操作天平)。Light光照Balancesshouldbeprotectedfromdirectsunlight(heat).天平应该避免阳光直射(温度)。Air气流OMCLsshouldnotplacebalancesintheairflowofairconditionersordeviceswithventilators(suchascomputersorlargelaboratoryequipment),next

22、todoorwaysorinareasofhightraffic.Thisisbecauseinadditiontothepotentialtemperaturedrift,strongaircurrentscaninterferewiththefunctioningofbalances.Ifabalanceisplacedinalaminarflowworkstation,e.g.forweighingoftoxicmaterial,thecabinetshouldbesuitablefortheintendeduse.OMCLs不应该将天平放置于空调或气扇等风源(电脑或大型实验室装置)产生

23、的气流中，靠近门或者人流多的地方。因为除了潜在的温度漂移，强气流可能干扰天平的运行。如果将天平置于层流台中，例如：有毒物料称量，应使用防风罩以满足要求。Weighingvesse/称量容器OMCLsmustensurethat:OMCLs必须确保thesmallestpossibleweighingvesselsareused.使用尽可能小的称量容器。ifthematerialsthattheweighingvesselismadeofhaveahighdegreeofelectricalinsulation(suchasglassandplastic),theyarenotelectrost

24、aticallycharged.具有高度绝缘性的材料（如：玻璃与塑料）不应带有静电电荷（注：高绝缘性材料本身不带静电，但不能释放集聚的电荷）。theweighingvesselandthesampleitcontainsshouldhavethesametemperatureastheirsurroundings.称量容器及样品的温度应当与环境温度相同。iftheweighingvesselhasbeenremovedfromadryingovenordishwasher,itshouldbecooledtoroomtemperaturepriortobeingplacedonthebalan

25、ce.从干燥箱或清洗机中取出的称量容器，称量前应冷却至室温。dependingonthetypeofbalance,itisrecommendedtousecottongloves.推荐使用棉手套，这取决于天平类型。nomagnetsshouldbeplacedonthebalanceorintotheweighingvessel.天平或称量容器中不能放置磁性物质。REQUIREMENTSFORWEIGHTSUSEDINTHEQUALIFICATION确认所用砝码的要求Weightsusedforqualificationshould:用于确认的砝码：becleanand,ifnecessar

26、y,wipedwithethanol.Inthelattercaseawaitingtimemustbetakenintoaccountbeforetheweightisused应干净，必要时用乙醇擦拭。如用乙醇进行过擦拭，则在称量前必须考虑等待时间。bestoredinadust-freeenvironment.应储存在无尘环境中。behandledwithcare;theuseofcottonglovesorforceps/tweezersisespeciallyrecommended.应该小心取用；推荐使用棉手套或镊子/钳子。haveasuitableaccuracy,depending

27、onthetypeofbalance.有合适的准确度，这取决于所用的天平类型becalibratedbyanaccreditedexternalserviceprovider.由官方认可的外部服务提供商校准合格。bere-calibratedperiodically.应周期性再校准。beclearlymarkedaftereachcalibration.每次校准后应清楚标识notbemadeofmagnetisablematerial.不能用磁性材料制作theverification(inusecontrol,seeTable3)maybedonewithnon-calibratedweigh

28、ts.检定(使用控制，见表3)可以使用未校准砝码FREQUENCYOFQUALIFICATION确认频次OMCLsmustensurethatqualification/calibrationofbalancesisdoneonreceipt(i.e.immediatelyafterdelivery)orpriortotheirfirstuseandafteranyrepairormove.OMCLs必须确保天平接收时进行了确认/校准(即交货后立即进行)或者在第一次使用前和维修或移动后进行。Thefrequencyofqualification/calibrationdependsonthee

29、xtentofuseofthebalancesandisatthediscretionofindividualOMCLs.确认/校准频次取决于天平使用程度和各OMCLs的决定。Qualification/calibrationmustbeperformedinaccordancewithapre-determinedprotocolinwhichacceptancecriteriaaredefined.Anexternalcalibrationshouldbeperformedbyorganisationsaccreditedascalibratinglaboratoriesaccording

30、toISO/IEC17025or,ifperformedinternally,thelaboratoryshouldsatisfythesamerequirementsintermsofmeasurementstandards,calibrationprocedure,useofcertifiedweightsandqualificationofpersonnel.确认/校准必须按照预定方案执行，方案中应规定可接受标准。外部校准应由被认可作为校准实验室的机构根据ISO/IEC17025进行；或者执行内部校准，实验室应该在测量标准、校准程序、标准砝码使用和人员资质确认方面满足相同的要求。Tabl

31、e3prescribestheparameters,typicalfrequenciesandtolerancelimitsforthequalificationofbalancesforperiodicandmotivatedinstrumentchecks(LevelIII)andin-useinstrumentchecks(LevelIV)表3天平的周期性主动仪器检查(第三级)和在用仪器检查(第四级)建议的参数，典型的频次和可接受限度Table3Parametertobechecked检查参数Frequency频次Typicaltolerancelimit接受标准Levelling调节水

32、平everydaybeforeweighingbegins每天称量开始前Acceptancelimitsofthebalance天平的接受标准Internalcalibration(adjustment)(automaticormanual)内部校准(校正)(自动或手动)everydaybeforeweighingbegins每天称量开始前Automaticacceptancelimitsofthebalance天平的自动接受标准Verification(inusecontrol)检定(使用控制)Atleastonceaweek至少一周一次OMCLsshalldefinetheirownacc

33、eptancecriteriaOMCL应该规定自己的可接受标准Accuracy准确度FrequencytobedefinedbyOMCL,typicallyonceayear由OMCL规定频次，通常一年一次OMCLsshalldefinetheirownacceptancecriteriaOMCL应该规定自己的可接受标准Linearity线性FrequencytobedefinedbyOMCL,typicallyonceayear由OMCL规定频次，通常一年一次OMCLsshalldefinetheirownacceptancecriteria(k=10.0001)OMCL应该规定自己的可接受

34、标准(k=10.0001)Precision精确度FrequencytobedefinedbyOMCL,typicallyonceayear由OMCL规定频次，通常一年一次OMCLsshalldefinetheirownacceptancecriteria(SD=maximum5*d)OMCL应该规定自己的可接受标准(SD=maximum5*d)Eccentricity偏载FrequencytobedefinedbyOMCL,typicallyonceayear由OMCL规定频次，通常一年一次OMCLsshalldefinetheirownacceptancecriteria(RSD=0.05

35、%)OMCL应该规定自己的可接受标准(RSD=0.05%)k=correlationcoefficient相关系数SD=standarddeviation标准偏差RSD=relativestandarddeviation相对标准偏差ThefollowingqualificationtestsmayalsobeperformedinadditiontothosedescribedinTable3(recommended,notobligatory):除表3中描述的项目，还可以执行下述确认测试(推荐，非强制)：Parametertobechecked检查参数Frequency(recommende

36、d)频次(推荐)Typicaltolerancelimit可接受标准Linearityerror线性误差onceeverysixmonths每6个月1次OMCLsshalldefinetheirownacceptancecriteria(accuracyofthebalances)OMCL应该规定自己的可接受标准(天平的准确度)Drifttest漂移测试onceeverysixmonths每6个月1次OMCLsshalldefinetheirownacceptancecriteria(RSD=0.05%)OMCL应该规定自己的可接受标准(RSD=0.05%)Minimumweight最小称量o

37、nceayear每年1次OMCLsshalldefinetheirownacceptancecriteriadependingonthetypeofthebalanceOMCL应该规定自己的可接受标准，取决于天平类型Measurementuncertainty测量不确定度onceayear每年1次OMCLsshalldefinetheirownacceptancecriteriadependingonthetypeofthebalanceOMCL应该规定自己的可接受标准，取决于天平类型QUALIFICATIONPROCEDURE确认程序Verification校准Verificationoft

38、hebalanceisperformedbyplacingasuitableweight(dependingonthetypeofbalance)inthecentreoftheweighingpanonceandcomparingtheresultwithpre-definedacceptancecriteria.Thesameweightshouldalwaysbeusedintheseverifications.TheacceptancecriteriashallbedefinedbyeachindividualOMCL.天平的校准就是把合适的砝码(取决于天平的类型)放置在秤盘中央进行一

39、次称量，然后和预定的可接受标准比较。在这些检查中，应始终使用相同的砝码。可接受标准应该由每个OMCL单独规定。Accuracy准确度Theaccuracyofthebalanceischeckedbyweighingatleastthreedifferentcertifiedweightsthatcovertheusualweighingrangeofthebalance.Itisrecommendedthattheweightshaveapproximate%,50%and100%ofthemaximumcapacityofthebalance(orofthemaximumweightuse

40、donthebalance),dependingonthetypeofbalance.Itisrecommendedthattheweighingisrepeatedatleast5timesforeveryweight,particularly,whentheresultsshallalsobeusedinthetestforprecision.TheacceptancecriteriashallbedefinedbyeachindividualOMCL.天平的准确度检查应选择涵盖天平称量使用范围的至少3个不同的标准砝码进行称量。推荐的砝码为天平最大称量能力5%，50%和100%的砝码(或天

41、平使用的最大称量值)，这取决于天平类型。推荐每个砝码重复称量5次，特别是当结果同时用于评估精确度时。Linearity线性Theresultsobtainedfromaseriesofaccuracycheckscanbeusedtocalculatethecorrelationcoefficientandtocheckforlinearity.Thecorrelationcoefficientiscalculatedbycomparingthenominalandmeasuredmassesoftheweights.Theacceptancecriteriaforthecorrelation

42、coefficientshallbedefinedbyeachindividualOMCL.(Proposedcriterion:k=10.0001).准确度测试所得系列结果可以用于计算相关系数和检查线性。相关系数通过比较砝码的标称值和测量值进行计算。相关系数的可接受标准应由各OMCL分别规定。(建议标准:k=10.0001).Precision精确度Theprecisionofthebalanceshouldbeverifiedbyweighingatleast5timesaweightthatisequivalenttoapproximately50%ofthemaximumcapacit

43、yofthebalance.Itisrecommendedtorepeatthetestwithaweightthatisequivalenttoapproximately5%ofthemaximumcapacityofthebalance,ifthebalanceisusedatthelowerrange.TheacceptancecriteriashallbedefinedbyeachindividualOMCL.(Proposedcriterion:SD=max5*d,whered=(actual)scaleinterval(eg.d=0.1mg).天平的精确度应该使用天平最大量程大约5

44、0%的砝码进行确认，砝码称量至少5次。如果天平在低量程使用，推荐使用天平最大量程大约5%的砝码重复该测试。可接受标准应该由各OMCL分别规定。(建议标准：SD=最大5*d，此处d=实际分度值(例如d=0.1mg)Eccentricity偏载Theeccentricitytestshouldbecarriedoutusingaweightequivalenttoatleast30%ofthemaximumcapacityofthebalance(orofthemaximumweightusedonthebalance).Theweightshouldbeplacedbetweenhalfwayt

45、o%ofthedistancefromthecentreofthepantoitsedgeandbemeasuredateachlocationinthefollowingsequencecentre,frontleft,backleft,backright,frontright,and（optional）againcentre.TheacceptancecriteriashallbedefinedbyeachindividualOMCL.（Proposedcriterion:RSDnotmorethan0.05%,calculatedfromallweighingsatdifferentlo

46、cationsonthepan）.偏载测试应该使用天平最大量程大约30%的砝码进行确认（或者实际使用的最大称量值）。砝码应放置在从秤盘中心到其边缘一半到3/4的位置，按照如下顺序测量每个位置的显示值：中心、左前、左后、右后、右前和中心（可选）。可接受标准应该由各OMCL分别规定。（建议标准:在称盘中不同位置测量结果的RSD不得过0.05%）Linearityerror线性误差Linearityerroristestedatleast3timesusingfourweightsofdefinedmasseswhoseaggregatetotalmassisapproximatelyequalto

47、halfofthemaximumcapacity,dependingonthetypeofbalance.线性误差应使用4个标准砝码进行测定，其合计的总重量约等于最大量程的一半，至少测定3次，取决于天平的类型。First,thecombinedmassofallfourweightsisweighedandrecorded.Then,twosub-setsofweightsaremadeandtheirmassesarerecorded.首先，所有四个砝码的组合重量被称量记录。然后，将砝码分成两组，称量记录砝码的重量。Thelinearityerrorofthebalanceisanabsol

48、utevaluecalculatedbythedifferencebetweenthecombinedmassofallfourweightsandthesumofthemassesfromthetwosub-setsofweights,dividedby2.天平的线性误差是四个砝码的组合质量和两组砝码质量总和的差值除以2的绝对值。TheacceptancecriteriashallbedefinedbyeachindividualOMCL.（Proposedcriterion:linearityerroraccuracyofthebalances）.可接受标准应该由各OMCL分别规定。（建议

49、标准:线性误差天平的准确度）Drifttest漂移测试Adrifttestisonlyperformedon5,6or7decimalscalebalances.Itiscarriedoutbyrepeatedmeasurements(every5minutesfor30minutes)ofacontrolweight(dependingonthetypeofbalance)inthemorningandafternoon.Themeanmeasurement,standarddeviationandrelativestandarddeviationcanbecalculatedfromtheresultingdata.Thedriftcanalsobeextractedfromthetrendanalysisoftheverificationtest(Table3).TheacceptancecriteriashallbedefinedbyeachindividualOMCL.(Proposedcriterion:RSD=0.05%).仅仅显示位数为小数点后5,6或7位的天平做漂移测试。使用一个控制砝码(取决于天平类型)进行重复测量(每5分钟测定一次，测