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1、Council Directive 93/42/EEC of 14June 1993 concerning medicaldevicesMDDDirectiveCENov 2008TV SD ChinaTUV SD China, Shanghai branchWCC 08.10.29WCC 08.10.29WCC 08.10.29MDDMDD1993712Official Journal of the European:Communities19982000200220200320072007/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXn

2、umdoc&lg=en&numdoc=31993L0042&model=guichettL1.2.3.CETUV SD China, Shanghai branchWCC 08.10.29TUV SD China, Shanghai branchMDDMDD:-TUV SD China, Shanghai branchWCC 08.10.29TUV SD China, Shanghai branch1MDDMDDMDDMDDMDD90/385/EEC98/79/ECAIMDDIVDD76/768/EEC2001/83/EC89/686/EEC76/768/EEC2001/83/EC89/686

3、/EEC TUV SD China, Shanghai branchWCC 08.10.29WCC 08.10.29WCC 08.10.29TUV SD China, Shanghai branchWCC 08.10.29WCC 08.10.29WCC 08.10.29MDDMDDIEssential RequirementsMDDMDDIIVIII68ICE.5.6.CECETUV SD China, Shanghai branchTUV SD China, Shanghai branchMDDIXIIIa IIb III60CE6030CETUV SD China, Shan

4、ghai branchTUV SD China, Shanghai branch2145.IIIIaIIaIIbIIaIIaIIaIIaIIbTUV SD China, Shanghai branchTUV SD China, Shanghai branchTUV SD China, Shanghai branchWCC 08.10.29WCC 08.10.29WCC 08.10.29TUV SD China, Shanghai branchWCC 08.10.29WCC 08.10.29WCC 08.10.299-12.6-8.IIaIIaIIbIIaIIbIIbIIaIIIIIIb/III

5、IIaITUV SD China, Shanghai branchMDDMDD13-18.X-rayIIbIIIIIbIIIIIbIIaIIIIIIIIbTUV SD China, Shanghai branch3IVII +VIIIIIb,IIaIII,IIbIIa,IIVIIAnnex3CE Type ExaminationCE Type Examination CertificateAnnex7Annex2Annex2EC Declarationof ConformityEC Declarationof ConformityECIIaDeclarationof ConformityFul

6、l QASystemAuditFull QASystemAuditIII,IIb,IIa,I*Annex4III,IIb,IIa,I*III,IIb,IIa,I*IIb,IIa,I*Annex6ISO13485IIIIAnnex4 Annex5+4EC DesignExaminationECECECECVerificationStatisticalSamplingVerification Declaration DeclarationProductAuditDecisionAuditDecisionISO13485VII + VTestingProductionQA SystemAuditPr

7、oductQA SystemAuditSurveillanceSurveillanceISurveillance SurveillanceTUV SD China, Shanghai branchWCC 08.10.29TUV SD China, Shanghai branchWCC 08.10.29IVII +VIVII +V/VIVIIIIIaVIIIIIIaISO13485VII +IV/VIVII +VIIIbISO13485IIIIVII +IV4ISO13485VIII +TUV SD China, Shanghai branchWCC 08.10.29TUV SD China,

8、Shanghai branchWCC 08.10.29IVII +V/VIVII +VIIIaVIIIIIaVIIIIVII +IV/VIIIIIVII +III +IV/IV/V/V/VIVIIIbISO13485VII + VIIIbIIIISO13485IIIII +IVISO13485VIII +III +IVTUV SD China, Shanghai branchWCC 08.10.29TUV SD China, Shanghai branchWCC 08.10.294VII ECV ECII ECCEMDDCECEICEII4IIITUV SD China, Shanghai b

9、ranchWCC 08.10.29TUV SD China, Shanghai branchWCC 08.10.29CEIIICETUVCEIV ECVI ECVIIIPart ATUV SD China, Shanghai branchWCC 08.10.29TUV SD China, Shanghai branchWCC 08.10.29CECETUVMDDIIMDDCEPart BPart BTUVISOTUV SD China, Shanghai branchWCC 08.10.29TUV SD China, Shanghai branchWCC 08.10.295MDD EN980

10、2008EOhttp:/ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist/meddevic.htmlEN 60601EN ISO 10993EN ISO 11137EN ISO 11607LTUV SD China, Shanghai branchWCC 08.10.29TUV SD China, Shanghai branchWCC 08.10.29CENotified Bodyhttp:/ec.europa.eu/enterprise/manufacturer()newapproach/nando/in

11、dex.cfmCE2006 11 MEDICA53%TUV SUDCETUV SUD35%Siemens Johnson & Johnson GE 3M65Cardinal500TUV SD China, Shanghai branchWCC 08.10.29TUV SD China, Shanghai branchWCC 08.10.29MDDEK-MED 3.9B16CECEpart Aa.b.CETUV SUDISO13485ISO13485TUV SUDTUV SUDTUV SUDc.TUV SD China, Shanghai branchWCC 08.10.29TUV SD Chi

12、na, Shanghai branchWCC 08.10.296a.EN550/EN552/EN554/EN ISO11137ISO13485 TUV SUDb.TUV SUDTUV SD China, Shanghai branchWCC 08.10.29WCC 08.10.29WCC 08.10.29TUV SD China, Shanghai branchWCC 08.10.29WCC 08.10.29WCC 08.10.29CECECECEMDD5CECEICE5CETUV SUD50123TUV SD China, Shanghai branchTUV SD China, Shang

13、hai branchCECE.CECETUV SD China, Shanghai branchTUV SD China, Shanghai branch7CETV SDCETV SD2TUV SD China, Shanghai branchWCC 08.10.29TUV SD China, Shanghai branchWCC 08.10.29TV SDMDD 20072007 09MDDCETUV1.2.TUVTUV(arcus aorta)IIaIIICE()IIbXIIa3.MDD Annex I)67/548/EECTUV SD China, Shanghai bra

14、nchWCC 08.10.29TUV SD China, Shanghai branchWCC 08.10.29MDD 20072007 09MDDMEDICAL DEVICES Guidancedocument4.5.28MEDDEVCE5152.12/12008 12 212010 03 21MEDDEV 2.7.1MEDDEV 2.5/9http:/ec.europa.eu/enterprise/medical_devices/meddev/index.htmTUV SD China, Shanghai branchWCC 08.10.29TUV SD China, Shanghai branchWCC 08.10.298Recommendation NB-MEDAuditingofSubcontractorsCertification of OEM devicesZLG27NB-MED/2.5.1/CECERec52.5.5/Rec1NB-MED/http:/EK-MED 3.9B16/ index.php?http:

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