脳動静脈奇形手術用クリップ承認基準の制定について（PDF：701KB）
Contents
1. 16 169 2 32. 2 3 4
3. AN 3 4 i 5
4. Z E SUR RE ER CHE b S rs 5348 MERRE GOET Se fet Ci ieWIUDI DA 16 169 8
5. 4 8 i 49 tuU 4 9 1 GE
6. JIS T 14971
7. ESEON 5 ESURRINSHDNEIBBIIHRECRUERUNRGES NOE TuS ERR ERASOA EM SACER TEMERE CODD Bt ISEGXCHNSENEHUONEAURWE CRISE AR BOREAIOREO BERN UEIUV T REENE 4 8 RA DARE SR MB Eo C ERORAR BR
8. 5 PEDE 14 2
9. 4 ERRER E fivc Ro 530518 8 ITERA o HEROE vs dk SURRCOUE AMETE SERERE RR BE JR BL PIT REO WIE 5 JIS T 0993 1 1 JIS T 7402 4 4
10. 3 MENS 0
11. 2 aatis po d 1 16 169
12. 6 d n4 AMEA 8 AREAN T OAREN MATAME ERER E RA 12
13. REGAT 11 BAR RER 2 7
14. j pi 10 i 7 3 10 ARAH 0310003 4
15. 4 16 169 5 BONED HAE SCEHE FEE REGEL CR 8 IO MUR Re OU d JIS T 14971 WSR
16. ZAWP e 6 5 ISO 9713 4 1 JIS T 7402 4 ISO 5832 7 ASTM F1058 4 2 3 Y D 3 4 3 3 5 4 4 mm 6 9 2 5 0 7 0 9 45 4 5 1 N FE gD 0 69 70 4 5 2 1 z
17. 2 1 6 0216002 1 7 4 2 1 7 3 3 1 0331012 SS 1 ABRIAM FA Y y TAREN 2 5 7
18. 2 3 4 WERE TAISE FCR EO ELE LI 5
19. 6 6 amp 0 HOD RURSHSIV CIO RRETAN 13
20. 1 1 E 2 pal JIS T 0993 1 2 i JIS T 7402 4 4 JTS T 7402 4 JIS T 14971
21. 3 9 T m 3 10 MR Ii MR I MR I C 3 1 E uj i lj 3 12 MR 1 MR I
22. 4 9 2 5 ISO 9713 pe c Q WETS RAE FA Ximi 2 3 3 3 4 5 mm 0 0 8 3 6 2 3 6 1 9 3 4 1
23. 2 1 7 2 1 6 0216002 3 1 4 9 6 2 1 4 1 1 9 2 1
24. 16 169 TIS T 14971 i 4 9 JIS T 14971 6 DERI GEN 07 v 72K ER dE 4 3 4 4 4 5
25. o Q0 QD 12 3 MR 1 UMR I 14 15 MR I MR I 16
26. IBARRA 8088 Y y 7 RU 5 1 l 9 JIS T 14971 isl ERI TRUST TEAREN JIS T 14971 MOARE ERY EAREN RR 9S 37253 EL CCS 4 6 K
27. JIS T 14971 17 3 30 0330001 GMP QMS 4 4 dd ISO 5832 7 Implants for surgery Metallic materials Part 7 Forgeable and cold formed cobalt chromium nickel molybdenum iron alloy IS0 5832 7 ISO 9718 Neurosurgical implants Self closing intracranial aneurysm clips OAT FISO 9713 ISO 11134 Sterilization of health care products Requirements for validation and routine control Industrial moist heat sterilization IS0 11134 ISO 11135 Medical devices Validation and routine control of ethylene oxide sterilization AF TISO 11135 IS0 11137 Sterilization of health care products Requirements for validation and routine control Radiation sterilization PAF ISO 11137 5 1S0 14630 Non Active surgical implants General requirements A F TISO 14630 ASTM F10
28. JIS T 14971 2 dg hie Ye 4E 51 3 ERDUT 4
29. p iid 15 2 16 TG 2 3
30. 7 GERI MARR 8088 7 v 77 RE dE TS 13 EU MEM RB S Cu 2l 0 2 Z5 ELORE NER RARO STRA c3 4 8 DEDE 8 16 169 9 Esci 4 9
31. 2 196 045 5 60 2 4 5 2 1 1 Omm 1mn 4 6 4 6 1 1 5 MR I JA EH 4 6 2 i 45 ASTM F2052 47
32. JIS T 14971 JIS T 14971 2 E
33. 1 6 2 9 8 1 1 6 2 20 3 25 1 2 1 3 4 2 5
34. ISO 5832 7 Implants for surgery Metallic materials Part 7 Forgeable and cold formed cobalt chromium nickel molybdenum iron alloy Introduction ASTM FI058 Standard Specification for Wrought 40Cobalt 20Chromium l16Iron 15Nickel 7Molybdenum Alloy Wire and Strip for Surgical Implant Applications UNS R30003 and UNS R30008 6 WEND r 8 BONUS OA MERO INDE LIRE RAE EAST 16 169
35. JIS T 14971 ou oki ED p EEOCHSOBERE 2 ERIRE A OEH A RRR EOT KK AEGRO fis Re Tcr RE L0 RARU NEST AER 3 10
36. 1 EMO eH BICIS URR JIS T 7402 4 4 d ISO 5832 7 Implants for surgery Metallic materials Part 7 Forgeable and cold formed cobalt chromium nickel molybdenum iron alloy Introduction ASTM F1058 Standard Specification For Wrought 40Cobalt 20Chromium 16Iron 15Nickel 7Molybdenum Alloy Wire and Strip for Surgical Implant Applications UNS R30003 and UNS R30008 X2 Biocompatibility Z WE MEREJCOE DS ER JIS T 7402 4 4 4 4 WARRE s 1S0 5832 7 Implants for surgery Metallic materials Part 7 Forgeable and cold formed cobalt chromium nickel molybdenum iron alloy 5 Mechanical properties ASTM F1058 Standard Specification for Wrought 40Cobalt 20Chromium l6Iron 15Nicke l 7Molybdenum Alloy Wire and Strip for Surgical implant Applications UNS R30003 and UNS R30008 6 Mechanical Requirements 2
37. MEAE E 7 zi HBERCUTRIAE JIST 0993 1 1 JIST 7402 4 ISO 5832 7 Implants for surgery Metallic materials Part T Forgeable and cold formed cobalt chromium nickel molybdenum ir n alloy Introduction ASTM F1058 Standard Specification for Wrought 40Cobalt 20Chromium 16lron 15Nickel 7Molybdenum Alloy Wire and Strip for Surgical Implant Applications UNS R30003 and UNS R30008 X2 Biocompatibility JIS T 0993 1
38. E R AOI IS C CURES Sen IAE ER U Le ru Boo OPERIS UAR VT E 4 E
39. IIS T 14971 amp y JIST 0993 1 1 Eod pr Rd Cm 3
40. a E b 2 a b a tw h b 2 3 6 3 6 1 3 6 2 3 7 d RETARA Magnetic Resonance Imaging MRI voids 3 8
41. 5 1 17 3 10 0910003 17 2 16 0216002 2 1
42. 58 Standard Specification for Wrought 40Cobalt 20Chromium 16Tron 15Nicke1 7Molybdenum Alloy Wire and Strip for Surgical Implant Applications UNS R30003 and UNS R30008 ASTM FIO58 5 ASTM F2052 Standard Test Method for Measurement of Magnetic ResonanceEnvironment TF lASTM F2052 5 EN 550 Sterilization of medical devices Validation and routine control of ethylene oxide sterilization LAF TEN 550 ATF JIS T 0993 1 EN 562 Sterilization of medical devices Validation and routine control of sterilization by irradiation EN 552 EN 554 Sterilization of medical devices Validation and routine control of sterilization by moist heat EN 554 EN 556 1 Sterilization of medical devices Requirements for medical devices to be designated STERILE Requirements for terminally sterilized medical devices TEN 556 1 EN 556 2 Sterilization of medical devices Requirements for medical devices to be designated STERILE Part 2 Requirements for aseptically processed medical devices EN 556 2 3 1 IS
43. FH 0325019 2 0 3 25 3 5 1 4 5 1 4 1 1 9 2 1 1 4 9 1 9 2 5 b 1 VD Ej 1
44. O 9713 a E 3 2 Jj 859 CA TER C CA ffs I 3 3 3 4 3 41 3 4 2 1 B 3 4 3 f om 3 mi C T mnt 1 1 A 5 Fl A BR ji bs B y il C 3 5
Download Pdf Manuals
Related Search