ISO 15197-2013 In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

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1、INTERNATIONALISOSTANDARD15197Secondedition2013-05-15Invitrodiagnostictestsystems—Requirementsforblood-glucosemonitoringsystemsforself-testinginmanagingdiabetesmellitusSystèmesd’essaisdediagnosticinvitro—Exigencesrelativesauxsystèmesd’autosurveillancedelaglycémiedes

2、tinésàlapriseenchargedudiabètesucréReferencenumberISO15197:2013(E)Licensedtookbiotech/Ms.wangISOStoreorder#:10-1335875/Downloaded:2013-06-14Singleuserlicenceonly,copyingandnetworkingprohibited©ISO2013ISO15197:2013(E)COPYRIGHTPROTECTEDDOCUMENT©ISO2013Allrightsreserv

3、ed.Unlessotherwisespecified,nopartofthispublicationmaybereproducedorutilizedotherwiseinanyformorbyanymeans,electronicormechanical,includingphotocopying,orpostingontheinternetoranintranet,withoutpriorwrittenpermission.PermissioncanberequestedfromeitherISOattheaddres

4、sbeloworISO’smemberbodyinthecountryoftherequester.ISOcopyrightofficeCasepostale56•CH-1211Geneva20Tel.+41227490111Fax+41227490947E-mailcopyright@iso.orgWebwww.iso.orgPublishedinSwitzerlandLicensedtookbiotech/Ms.wangISOStoreorder#:10-1335875/Downloaded:2013-06-14Sing

5、leuserlicenceonly,copyingandnetworkingprohibitedii©ISO2013–AllrightsreservedISO15197:2013(E)ContentsPageForeword.........................................................................................................................................................

6、...............................................................................ivIntroduction............................................................................................................................................................................

7、......................................................v1Scope............................................................................................................................................................................................................

8、.....................12Normativereferences.......................................................................................................