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ID:10349312
大小:1.35 MB
页数:80页
时间:2018-07-05
《BS-EN-ISO-10993-10-2013 biological evaluation ofmedical devices》由会员上传分享,免费在线阅读,更多相关内容在行业资料-天天文库。
1、BSENISO10993-10:2013BSIStandardsPublicationBiologicalevaluationofmedicaldevicesPart10:TestsforirritationandskinsensitizationBSENISO10993-10:2013BRITISHSTANDARDNationalforewordThisBritishStandardistheUKimplementationofENISO10993-10:2013.ItisidenticaltoISO10993-10:2010.Itsu
2、persedesBSENISO10993-10:2010whichiswithdrawn.TheUKparticipationinitspreparationwasentrustedtoTechnicalCommitteeCH/194,Biologicalevaluationofmedicaldevices.Alistoforganizationsrepresentedonthiscommitteecanbeobtainedonrequesttoitssecretary.Thispublicationdoesnotpurporttoinc
3、ludeallthenecessaryprovisionsofacontract.Usersareresponsibleforitscorrectapplication.©TheBritishStandardsInstitution2014.PublishedbyBSIStandardsLimited2014ISBN9780580854958ICS11.100.20CompliancewithaBritishStandardcannotconferimmunityfromlegalobligations.ThisBritishStanda
4、rdwaspublishedundertheauthorityoftheStandardsPolicyandStrategyCommitteeon28February2014.AmendmentsissuedsincepublicationDateTextaffectedEUROPEANSTANDARDENISO10993-10NORMEEUROPÉENNEEUROPÄISCHENORMAugust2013ICS11.100.20SupersedesENISO10993-10:2010EnglishVersionBiologicaleva
5、luationofmedicaldevices-Part10:Testsforirritationandskinsensitization(ISO10993-10:2010)Évaluationbiologiquedesdispositifsmédicaux-Partie10:Essaisd'irritationetdesensibilisationcutanée(ISO10993-10:2010)ThisEuropeanStandardwasapprovedbyCENon9July2013.CENmembersareboundtocom
6、plywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEuropeanStandardthestatusofanationalstandardwithoutanyalteration.Up-to-datelistsandbibliographicalreferencesconcerningsuchnationalstandardsmaybeobtainedonapplicationtotheCEN-CENELECManagementC
7、entreortoanyCENmember.ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).AversioninanyotherlanguagemadebytranslationundertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheCEN-CENELECManagementCentrehasthesamestatusastheofficialversions.C
8、ENmembersarethenationalstandardsbodiesofAustria,Belgium,Bulgaria,Croatia,Cyprus,CzechRepublic,De
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