ISO13485-2016中文版.pdf

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1、INTERNATIONALISOSTANDARD13485第3版2016-03-01医疗器械—质量管理体系—用于法规的要求Dispositifsmédicaux—Systèmesdemanagementdelaqualité—ExigencesàdesfinsréglementairesReferencenumberISO13485:2016(E)©ISO2016ISO13485:2016(E)COPYRIGHTPROTECTEDDOCUMENT©ISO2016,PublishedinSwitzerlandAllrightsreserved.Unlessotherwisespecifi

2、ed,nopartofthispublicationmaybereproducedorutilizedotherwiseinanyformorbyanymeans,electronicormechanical,includingphotocopying,orpostingontheinternetoranintranet,withoutpriorwrittenpermission.PermissioncanberequestedfromeitherISOattheaddressbeloworISO’smemberbodyinthecountryoftherequester.ISOcop

3、yrightofficeCh.deBlandonnet8•CP401CH-1214Vernier,Geneva,SwitzerlandTel.+41227490111Fax+41227490947copyright@iso.orgwww.iso.org2©ISO2016–AllrightsreservedISO13485:2016(E)目录Page前言.......................................................................................................................

4、...................................................................................................................................v引言..................................................................................................................................................................

5、......................................................................................vi1范围.............................................................................................................................................................................................................

6、.........................12规范性引用文件...........................................................................................................................................................................................................13术语和定义....................................................

7、.....................................................................................................................................................................14质量管理体系...................................................