医療機器指令 93/42/EEC の概要(第2版)
Contents
1.2.
3.
4.
5. 98 79 EC IVD e 90 385
6. ts 8 9 10 11 12 13 62 00000 Declaration Conformity NB MED S 01 99 63 0000000 500 1500
7. 9 4 0000 Article 15 Annex VIII Annex X MEDDEV 2 78 9 5 0000
8. Annex II 000000 0000 000000 1000000 20000 Class Class V V V V v v v V Class v v TY V V Class IIb V V V Class III v V J 4 00000 Annex II Annex VII Annex VII EC notified body 3 41 Annex 0000000000 1 2 EC design examination certificate Class IIb 3
9. 11
10. 3 1 1 1 transient 60 2 short term 30 3 long term 30 3 1 2 1 invasive device 2 body orifice 3 surgically invasive device 4 implantable device 5 reusable surgical instrument 6 active medical device T active therapeutical device 8 active device for diagnosis 0000000000000000000000000000000000000000000000000000000080 000000000000000000000000000000000 LTD 4 OHTAMA
11. 111 Consensus Statements of Notified Bodies Medical Devices om Council Directives 90 385 EEC 93 42 EEC and 98 79 Consensus Statement S 01 99 Declaration of Conformity 4 0000000000000000000000000000000000 00 00 0000 000000000000000000000000000000000000000000 00000000 0 0 000000000000000000000000000000 000000000000000000000000000 LTD 4 OHTAMA
12. 1 00 medical device directive MDD 1 11 00000 93 42 2007 47 m 93 42 EEC 2007 47 EC 03 42 as amended by 2007 47 12 0000000000800 93 42 EEC MDD
13. Annex IV EC 0 Annex V Annex VI 1 00 2 3 type examination certificate 4 5 EC 4 3 Annex IV Annex III EC Annex VII EC 1 Hm 2 a EC b 3 4 CE t10 Annex 0000 000000000000000 e OHTAMA LTD 4 OHTTAM A 4 4 Annex 1080000
14. Class Class IIb Class I Class IIb Class IIa 3 2 2 Class I lass I lass I lass IIa lass IIa lass IIb ass
15. 51 00000 1 b 2 state of the art a b c 3 4 5 6 SEA 52 00000000000 Annex
16. 13 LTD 4 OHTAMA
17. 3 2 00000 Annex IX Class ITa 4 e Class e Class IIa e Class IIb e Class III MEDDEV 2 4 1 Guidance document classification of medical devices 3 2 1 Class I Class IIa Class IIa Class Class I
18. LTD 4 6 _ 7 5 3 L 2 STERILE y d LOT f g custom made device h exclusively for clinical investigations i i k 1 m n 3 4 5 a 12 LTD 4 OHTAMA I 02 aa E
19. 3 2 5 Class III Class III Class III Class IIb Class IIb Class IIb Class IIa X Class IIa Class III Class IIb 33 0 00000000000 1 Class I a Annex VII EC b Annex II IV V VI 2 Class IIa a Annex II b Annex VII EC Annex IV EC c Annex VII EC Annex V d Annex VII EC Annex VI 3 Class IIb a Annex II b Annex III EC Annex IV EC c Annex EC Annex d Annex III EC Annex VI 4 Class III a Annex II b Annex III EC Annex IV EC c Annex III EC Annex 000000000000000000000000000000000000000000000000000000 00 00000000000 5 00000000000000000000000000000000000000000000 LTD 4 OHTAMA
20. 2 3 000000000 3 0 00000000000 31 000000000000 00000000000
21. Annex III EC Annex VII EC 4 5 Annex 100000 Annex III EC Annex VII EC Li 2 CE
22. Class LTD 4 OHTAMA 3 2 3 lass lass III lass I lass III lass IIb lass IIb lass IIb lass lass lass lass IIb lass III lass IIb lass IIb lass IIa lass III lass III ass III
23. guidelines on a medical devices vigilance system MEDDEV 2 12 1 Guidance document 96 0000000000000000000 2004 108 93 42 EEC amended by 2007 47 Article 1 6 2006 95 Annex II 2006 42 EC EEC Article 3 EHSR
24. lt gt SS B d oo WIL MED 6 00000 61 0000000000
25. EN 60601 1 EN 60601 1 2 9 2 000000 Article 14 EU authorized rep resentative Class IIa IIb III
26. 93 93 42 EEC manufacturer J OEM own brand labeller 16 LTD 4 OHTAMA
27. 00000 Annex DD IV 0 0 000 000000000 000 0000 D Class 0000 DD 0000000000000000000000000000000000000000 Annex 0 D 00 0 D Annex 0 000 Annex 000000 00000 Annex 0 000 Annex 000000 00000000 0 00000000 0 0000000000000000000000000000000 000000000000000000000 000000000000 LTD 4 OHTAMA 4 CE EC 4 2 Annex III 0 000
28. 0 B 2 0000000000000000000000 5mm CE CE R amp TTE CE CE 8 000000 Annex II JU Annex 0 Annex VI EN ISO 13485 3 4 Annex 0 D 0 020 VII 000000000000000000000000000000000000000 5180 13485 Medical devices Quality management systems Requirements for regulatory purposes Annex IV 0 00 000 Annex HI EC
29. lm lac 3 2 4 Class lass IIb lass IIb lass lass lass IIb lass IIa lass IIb Class IIb lass IIa Class I LTD 4 OHTAMA
30. LTD 4 OHTAMA 93 4 EEC 00 0 20 OOOO 0000 20130 10020 6 13 13 HE 2 62 14 2 Ge THHHH 14 TII 2 CE 15 P 2 TOPPED uuuuunl 15 o 3 3 16 3 DOO es xaxa 16 MP 3 93 16 A HIHI 17 Oa 9 17 quidc 5 5 LIT 372 8 oed a bua 17 5 E TT 6 6 DATA 7 T 7 E 10111 8 1 1 0000000000 8 Cee bees 9 9 4 Annex V 10 1 5 Annex VI 10 TETTE 10 HHL 10 11 11 12 LTD 4 OHTAMA
31. Interpretation the medical device directives in relation to medical device own brand labellers European Commission 2008 18
32. 4 6 Annex ECO O00 Annex IV EC Annex V Annex VI 2 CE 3 Class I Annex II EC IV EC 5 0000 essential requirements 10 10
33. LTD 4 OHTAMA
34. 98 79 ECO000000000 142001 83 20 0 00000000000000000000000000000000000000000000000000 000 2001 83 0 000 000 HD 0000 custom made device 00000 0000000000 000 0000 00 00000 00000 0000 0000 0000 164 intended for clinical investigation 0 0 0 00 00000000000 000000000000000000000 00000000000 e OHTAMA LTD 4 OHTTAM A
35. 17 e OHTAMA LTD 4 OA TAMA e R amp TTE 1999 5 EC R amp TTE R amp TTE Article 3 2 334 R amp TTE e RoHS 2011 65 EU 20140 70 22 RoHS WEEE 2002 96 EC 2012 19 EU WEEE 2006 66 10 0000 1 93 42 EEC Council Directive 98 42 of 14 June 1993 concerning medical devices N European Commission Enterprise and Industry Policies Harmonised standards Medical devices Team NB The European Association for Medical devices of Notified Bodies
36. 000 Annex IV 15 LTD 4 OHTAMA 9 00 9 4 0000 harmonised standards Official Journal OJ 2
37. EEC AIMD 2 0000 EU medical device B 20120 90000000000 0000000000 0000000000000000000006000000000000000000000000000000000000 000000000000000000000000000 LTD 4 OHTAMA 21 00000000000 1 yun B 2 90 385 3 2001 83 4 76 768 EEC 22 00000000000000 i Annex VIII CE
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