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1、?ISO2017Biocompatibilityevaluationofbreathinggaspathwaysinhealthcareapplications—Part1:Evaluationtestingwithinariskmanagementprocessvaluationdelabiocompatibilitdesvoiesdegazrespiratoiresdanslesapplicationsdesoinsdesant—P
2、artie1:valuationetessaisauseind’unprocessusdegestiondurisqueINTERNATIONALSTARDISO185621Firstedition201703ReferencenumberISO185621:2017(E)ISO185621:2017(E)Fewd..............................................................
3、..........................................................................................................................................................................ivIntroduction....................................
4、..............................................................................................................................................................................................v1Scope.......................
5、..........................................................................................................................................................................................................12Nmativereference
6、s......................................................................................................................................................................................2???????????????????????.............
7、........................................................................................................................................................................24Generalprinciplesapplyingto????????????????evaluat
8、ionof???????????????..........................64.1General...................................................................................................................................................................
9、........................................64.2??????????......................................................................................................................................................................
10、...........................74.3??????????????????????????????????????.......................................................................................................................84.4Extentof???????????????.....
11、......................................................................................................................................................84.5????????????????evaluationplan....................................
12、...................................................................................................94.6ionoftests...........................................................................................................
13、......................................................................104.7Subsequentevaluation.............................................................................................................................
14、.....................................105Contaminationofbreathinggasfrom????????????..................................................................................................115.1Durationofuse.....................
15、............................................................................................................................................................115.2???????????????????(??)emissions...........................
16、..................................................................................................135.3??????????????????????????(???)emissions.............................................................................
17、.........................135.4?????????????????????incondensate..........................................................................................................................136Adjustmentfdifferent???????group
18、s................................................................................................................................136.1Generalconsiderations.................................................................
19、................................................................................................13??????????????????????????????............................................................................................
20、.........................................................136.3Derivingapermittedconcentrationfroma??????????????????.....................................................147Derivingallowablelimits.........................
21、.............................................................................................................................................147.1General???????............................................................
22、......................................................................................................................147.2F?????????????????????????????????????????????????????????.......................................
23、.....................157.3F???????????????intendedfprolongedexposureuse(24hbut30d)..........................167.4F??????????????????????????????????????????????????????....................................................
24、............168?????????????????????....................................................................................................................................................................................169A
25、ssessthe????????????????ofthe??????????????....................................................................................................17AnnexA(infmative)Rationaleguidance.........................................
26、............................................................................................18AnnexB(infmative)Referencetotheessentialprinciples............................................................................
27、......................20AnnexC(infmative)??????????????????????????????????????????????????.......................................................21Bibliography............................................................
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