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1、?ISO2014Needlebasedinjectionsystemsfmedicaluse—Requirementstestmethods—Part1:NeedlebasedinjectionsystemsSystmesd’injectionaiguillepourusagemdical—Exigencesetmthodesd’essai—Partie1:Systmesd’injectionaiguilleINTERNATIONALS
2、TARDISO116081Thirdedition20141215ReferencenumberISO116081:2014(E)CopyrightInternationalganizationfStardizationProvidedbyIHSunderlicensewithISOLicensee=UniversityofAlberta5966844001User=ahmadirozitaNotfResale0106201523:28
3、:34MSTNoreproductionwkingpermittedwithoutlicensefromIHS````````````````````````ISO116081:2014(E)ContentsPageFewd............................................................................................................
4、..............................................................................................................................vIntroduction.................................................................................
5、.............................................................................................................................................vii1Scope......................................................................
6、...........................................................................................................................................................12Nmativereferences..............................................
7、........................................................................................................................................13Termsdefinitions..................................................................
8、...................................................................................................................14Symbolsabbreviatedterms................................................................................
9、...........................................................................35Requirements...................................................................................................................................
10、.......................................................................45.1General..........................................................................................................................................
11、.................................................................45.2Systemdesignations.....................................................................................................................................
12、......................................55.3Riskanalysisrequirements..........................................................................................................................................................
13、55.4Uncertaintyofmeasurementconfmancewithspecifications........................................................55.5Generaldesignrequirements................................................................................
14、.....................................................................56Reagentapparatus.....................................................................................................................................
15、.............................................76.1General....................................................................................................................................................................
16、.......................................76.2Testliquid.......................................................................................................................................................................
17、.............................76.3Balance....................................................................................................................................................................................
18、.......................76.4Testsurfaceffreefalltesting................................................................................................................................................77Determinationofdosea
19、ccuracy...........................................................................................................................................................77.1General...............................................
20、............................................................................................................................................................77.2Dosingregions...............................................
21、..........................................................................................................................................87.3Dosesettings..................................................................
22、...........................................................................................................................97.3.1Multidosecontainers(systemdesignationsAC)..................................................
23、..................97.3.2Singledosecontainers(systemdesignationsBD).................................................................97.4Assessment...........................................................................
24、......................................................................................................................97.4.1General.........................................................................................
25、.............................................................................................97.4.2Determinationofdoseaccuracylimits........................................................................................
26、..............107.4.3Determinationoflastdoseerrlastdoseaccuracylimits(systemdesignationsAC).................................................................................................................................
27、..............117.4.4Calculationofdosedeliveryefficiency(systemdesignationsB1D1userfilled)..................................................................................................................................
28、..............................117.4.5Calculationoftoleranceintervals...................................................................................................................128PreparationoperationofNISs........
29、.........................................................................................................................................129Testmatrix......................................................................
30、.........................................................................................................................................1310Testdeions.....................................................................
31、..........................................................................................................................1610.1General.....................................................................................
32、...................................................................................................................1610.2Coolstardwarmatmospheretesting.....................................................................
33、.....................................1610.2.1Preconditioning...........................................................................................................................................................1610.
34、2.2Testing....................................................................................................................................................................................1610.3Lastdosetesting(systemde
35、signationsAConly)......................................................................................1710.3.1General......................................................................................................
36、.............................................................................1710.3.2Preconditioning........................................................................................................................
37、...................................1710.3.3Testing..........................................................................................................................................................................
38、..........1710.4Lifecycletesting(systemsdesignationsABonly)—Preconditioning................................1710.5Freefalltesting............................................................................................
39、........................................................................................1710.6Dryheatcoldstagetesting—Preconditioning....................................................................................191
40、0.7Dampheattesting(systemdesignationsABonly)—Preconditioning...............................1910.8Cyclicaltesting(systemdesignationsABonly)—Preconditioning........................................1910.9Vibrationtesting—Pre
41、conditioning..............................................................................................................................20?ISO2014–AllrightsreservediiiCopyrightInternationalganizationfStardizationProvid
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