ISO 10993-1-2009

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1、INTERNATIONALISOSTANDARD10993-1Fourthedition2009-10-15Biologicalevaluationofmedicaldevices—Part1:EvaluationandtestingwithinariskmanagementprocessÉvaluationbiologiquedesdispositifsmédicaux—Partie1:Évaluationetessaisauseind'unprocessusdegestiondurisqueReferencenumberISO10993-1:2009(E)©I

2、SO2009ISO10993-1:2009(E)PDFdisclaimerThisPDFfilemaycontainembeddedtypefaces.InaccordancewithAdobe'slicensingpolicy,thisfilemaybeprintedorviewedbutshallnotbeeditedunlessthetypefaceswhichareembeddedarelicensedtoandinstalledonthecomputerperformingtheediting.Indownloadingthisfile,partiesa

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6、1Fax+41227490947E-mailcopyright@iso.orgWebwww.iso.orgPublishedinSwitzerlandii©ISO2009–AllrightsreservedISO10993-1:2009(E)ContentsPageForeword................................................................................................................................................

7、............ivIntroduction........................................................................................................................................................vi1Scope...................................................................................................

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