欧州進出に必要な医療機器の CEマーク制度の概要
Contents
1. gt A TUVRheinland Genau Richtig MDDS amp S amp EO2 37200 2 MDD amp zalEO2 32 0D A T VRheinland A Genau Richtig MDD EOI D OXJ YF 12 EKITEA TORRE RT B HE o 2 EU 3 Genau Richtig N MM INN o RN gom a WW LI PI LE LPS E NA er PA ej2. A TUVRheinland Genau Richtig CE MDD93 42 EEC 1 a a medical device means any instrument apparatus appliance software material or other article whether used alone or in combination including the software intended by its manufacturer to be used specifically for diagnostic and or therapeutic purposes and necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of Event Date Location Author A TUVRheinland Genau Richtig CE
3. ADI T J A TUVRheinland Genau Richtig Event Date Location Author CE 2F SIR I E A TUVRheinland Genau Richtig CE EU EU Ns A TUVRheinland Genau Richtig CE EU EU Harmonization A TUVRheinland _ A Genau Richtig BA 9M 3 HH LPS S2 7 Bs EET 00 CE x 7 AENM OM on TR ROSUR CC a TUVRheinland Genau Richtig PAM 3E EH I
4. C Genau Richtig A1 CE Evidence Technical Documentation CE EU ri Genau Richtig Q2 CE Technical Documentation Genau Richtig A2 Technical Documentation EU Declaration of Conformity TCF Technical Construction File TF Technical File
5. 1983 y 8 TUVRheinland CERTIFIED 6 AR 360 2012 A TUVRheinland Genau Richtig 1983 3 7 400 Mc A lt es n 27 1 A bow Ne 4e EM Ww e nae YA j FAR Du e NS 1 23 he tan gt 1 de r 5 7 N d o 4 F gt r And WE s eli ie GA A E tet a ip p t A E f DAE et T Ban Ca MEA ROER SM 3 A h ru 1 Mo e ON IRA a eet d E NY
6. GHTF rules cpm Class LRAT Class lla Low moderate risk Moderate high risk Ds Class llb Class Class Il Class Ill and IV A TUVRheinland Genau Richtig BA JM 38 EH 4p 2273 Ps TEES s 00 CE x HEN 93 42 EEC llb Ib gg Class lla IIb III Class lla Class Class IM Class IS CRATER DODD A TUVRheinland p Genau Richtig PAX JM 3 EH P S273 Ps TEES a 02 CE x 7 fll I 00 9L fap X A AU r3 CI Ilb E 7 z as
7. NB CA A TUVRheinland Genau Richtig PA JM 38 EH TP 327a ES TEASE 02 CE NC FREIEM CE EU EU EU iE MbeXEIS Genau Richtig CE Medical Device Directive 93 42 EEC InVitro Diagnostic Medical Device Directive 98 79 EC ANSIEHT Active implantable Medical Device Directive 90 385 EEC 3 2012 9 EU http ec europa eu health medical devices documents revision A TUVRheinland Genau Richtig Q1 CE
8. 2012 19264 19754 1969 1900 2010 2007 5 A TUVRheinland Genau Richtig 2008 2012 100 r47 I T VRheinland Genau Richtig One for all 2013 1 au TUVRheinland CERTIFIED A T VRheinland Genau Richtig 717 t A TUVRheinland Genau Richtig 1
9. CE CE S A T VRheinland Genau Richtig PA 9M 3E EH LP S273 s EISE 00 CE x 7 AENM CE Technical Documentation EU MOSHOSE SCRHTEIICOBECS 0197 A TUVRheinland Genau Richtig D Ok gt Q3 A3 Medical Device Directive 93 42 EEC EU Active Implantable Medical Device Directive 90 385 EEC BESJIERGA x PESE SR TE T EU InVitro Diagnostic Medical Device Directive98 79 EC A TUVRheinland Genau Richtig Q4 Declaration o
10. A T V 18 10 2013 28 Ss TUVRheinland Hheinland ism rw Service GmbH Genau Richtig CE A MALES gt SX an x E OD RE UR L ma KE Y ON m O n Ei TRE A T VRheinland Genau Richtig PX JM 3S EH Lp S273 E TEES a 02 CE x 7 AENM CE 8 Classification EU 6 MDD ILIII IV V VIVII Essential Requirement EN ISO 14971 EN ISO 13485 gt OMS 5 Clinical Evaluation Technical Documentation Class ll Design Dossier 6
11. RN Lg TUVRheinland Genau Richtig 2013150 18 Presentation T V Rheinland TTUVIEIK T echnischer con i berwachungs BE ER EA Verein I24722F1 amp 1872 A TUVRheinland Genau Richtig E f TUVRheinland Precisely Right 141 65 500 18 000 JA T VRheinland Genau Richtig 140 1872 1957 DUV 1918 2006 2009 PV
12. hme gt g gm EMC rip Ai m mw i x aec u 24277 ISO 9001 14001 27001 OSHAS 18001 ISO 22000 ISO 28000 201320 18 Presentation TUV Rheinland LA TUVRheinland Genau Richtig 2012 3 7 m B LACT mm T vRheinland Genau Richtig 65 18 000 Y jb Jy 1983 gt 7 400 Assessment Cantar GTAC Office Location 54 2013 10 18 Presentation T V Rheinland T VRheinland Genau Richtig E 1978 1979
13. European Authorized Representative Vigillance System 7 JFN Audit amp Certification by Notified Body 8 Declaration of Conformity p T D ox A TUVRheinland Genau Richtig PA JM 38 EH T 37a ES EA 02 CEN FREIEM EC mus EPHUE HU UR URRTON C A TUVRheinland enau Richtig a PAX JM 3 EH Lp S273 E EISE s 00 CE x 7 AENM E EU Class MDD EUOMDD3 r A 3 44 05 MDD m Class Classll Class IIb
14. A TUVRheinland Genau Richtig NORDRHEIN WESTFALEN CE BS Products P 05 Medical Manager RE EH E BE Genau Richtig ERWEE 00 ER s O A h DH IHGHTF Global Harmonization Task Force Health Canada 27 58 RE FDA510 k Therapeutic MDD IVDD Pre Market Goods AIMD Notification Regulations Approval EN ISO 13485 16 169 ISO 13485 under ISO 13485 QMS CMDCAS A TUVRheinland Genau Richtig PA JM 38 EH T 327a BS EAE 02 CE NC FREIEM EUNZEBIENZF m m m 3r hugs is e 1 EUMHEI lt a 20134E 2D 7 7 dong ZEN 28 ens S 5 EFTA V
15. Genau Richtig PA JM 38 EH T 327a S EAS 02 CEN FREIEM Technical Documentation CE A TUVRheinland Genau Richtig PA JM 38 EH T 37a S Mea 02 CE NC 7 fill S 00 40 e Technical File A TUVRheinland Genau Richtig
16. TI ET ER ERE 00 CE x IENE Er THAI DLE TH N loe EH 3 1 FE HE TH T EMC 21 Event Date Location Author A TUVRheinland Genau Richtig BA 9M 38 EH LPS S2 7 Ps EISE a 00 CE x 7 AENM C ENFEMON ITERNEUER CE EU S ROI VA EU CE gt Comunit Europ en BECIMZE aITA DES X F A TUVRheinland Genau Richtig PA Jh 38 EB TERT ER TREE SR 0 CE x 7 fll E 00 12 32 CE mEU ms EC U amp DoC Declaration of Conformity CE EU Essential Requirement State of the at
17. Y v g i ya 1978 A TUVRheinland Genau Richtig Global Technology Assessment Center GTAC 2005 6 GTAC Solar Energy Assessment Center 2009 FR TE EMC Kansai Technology Assessment Center KTAC ADOX 2012 A TUVRheinland Genau Richtig Info jpn tuv com TUVRheinland
18. f Conformity A4 Declaration of Conformity EU i 2005 3 31 SANBENE A TUVRheinland enau Richtig Q5 EU EU Genau Richtig A5 T V Rheinland EU N
19. heinland Genau Richtig CE EU State of the art State of the art A TUVRheinland Genau Richtig E Medical devices European standards Enterprise and Industry Microsoft Internet Explorer File Edit wiew Favorites Tools Help O i gt T N j Search S Favorites dynamic imaging EC 62420 1 Cenele EN 82304 2008 Medical device software Software life cycle processes C B2304 2006 EN ISO mmj Mun TI rmt Z7 A TUVRheinland Genau Richtig Cenelec EN 52356 2008 211 2008 Medica
20. l devices Application of usability engineering to medical devices EC 62365 2007 MDD 3 MDD 3 A TUVRhei nland ER can m MDD 3 3 MDD MDD MDD ENR ERTER HA 2 fHmEosste e 52 HCA A TUVRheinland Genau Richtig MDD 3 3 MDD
21. otified Body CE j O9 ft RECS Genau ei E u IE 4S ZR 422 La TUV Technischer Uberwachungs Verein 1872 G DUV DUV DUV TUV er A T VRheinland Genau Richtig SEEEEM a 3 I TOIRE L TERE 000
22. s Fidel ACIDS e Class Ill A TUVRheinland J Genau Richtig 93 42 EEC Vigilance System MEDDEV 10 U MEDDEV 2 12 1 rev 8 2013 Guidelines on a medical devices vigilance system A TUVR
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