平成20年3月25日 - 医療機器基準等情報提供ホームページ
Contents
1. 4 48 ADANY dt g REDL WIE 5 ERRORIS JIS T 0905 1 1 EUER ORE2. l a 6 l 7 x AHE RUM
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11. 3 iR o NERT BL JIS T 14971 duo BEBE CETTE FINZI 72K SR ATE 5 1 l EBORE OC 17 e 3 A 10 H ERE 0310003
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15. i Z 3 MEARE SOBE TORRETA 4 TERTRE EISE UI DOR OLOR ORSER
16. _3 4 3 1 C A B pu p ee Fo l 1 3 5 a b 2 a b vr Cop Ed2 18 6 3 6 1 ARAH 3 6 2 F Ex 3 7 SW Magnetic Resonance Imaging IM oids
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18. 4 16 2 NOS EN CR TAS 17 2 16 0216002 2 1
19. S 1 BIIRAR AES D v SARE 1 MBRO MIENE BNB ddr P d SN Re s m 1 MOB JIS T 0993 1 3 1 FERURI JIS T 0993 1 JIS T 7402 4 4 SEE JIS T 7402 4 JTS T 14971 A TIS T 14971 EUM 17 3 30 0330001 ERER OU OE t GMP QMS 4 4
20. f JIS T 14971 JATURUSURDESEER D JIS T 14971 16 109 9 m PENEXRORZEESAOHREHD 16 169 ais
21. 3 12 ZAFE 65v 5 4 BRIA 0 sri at 4 1 i JIS T 7402 4 ISO 5832 7 ASTM F1058 4 2 NE z E 3 3 83 4 3 3 5 4 4 mm Fr 45 4 5 1 1 N gD 0 4 5 2 1 B 2 1
22. JIST 7402 4 4 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 161ron 15Nickel 7Molybdenum Alloy Wire and Strip for Surgical Implant Applications UNS R30003 and UNS R30008 6 l 8
23. 2 ri ts 3 ERRES IETEBUIC BR SE JE AE OO UD do RTTR XC EARS TA 4 5
24. og 3 8 i m 1 3 9 Lo CHB S NORONHA MEDI Eo TET AZ EE E CR 3 10 MR I MR I MR I RE Bom T MR 1 MR I 3 11 2
25. 2 200 4 5 2 1 1 Omm 1m 4 6 4 6 1 2 mE 1 5 MR I ORBI X 0 DRAE FRA 2 U v Z DSapkielc2 Ji 87 EE 4 6 2 RS E 45 _ ASTM F2052 A7
26. ien 2 Es ODE poo mr 9 6 5 2 1 4 3 1 1 9 2 1 2 4 004 BG Sw STi MEERE BERE KE os eor OPRITE O 2 16 SUAE SUNIDIQA S TIEIRMUO NUS e e H R MEERRA 4 2 8
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30. 0325019 20 3 25 T D Re P Jot bei A PER er ji ess CE iii E RERO MEI OU C XY ERA SEWERA 4 5 MAF D 205 1 AAR TAAN 1 9 40 2 58 1TRICIJEO IBBIBRIRIC ATTE ARR Y y 7 BGB RR 1 4 9 1 9 2 5 CES RR Wis iov coxa 8 VDIRA BROWN ETEAWARERISER SS REP CERES o 7 1 02166mp 8 TERIMNONENOERE c de
31. 4 E i n l 2 D Bru 2 3
32. KEDARRA TAR 5 2 BMG 7 Lir Ap nios eth s mecs ico tL or te eer LAT ne JIS T 0993 1 1 i JIS T 7402 4 4 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 161ron 15Nickel 7Molybdenum Alloy Wire and Strip
33. X OF RESI Fa mE ISO 5832 7 Implants for surgery Metallic materials Part 7 Forgeable and cold formed cobalt chromium nickel molybdenum iron alloy SAF TISO 5832 7 ISO 9713 Neurosurgical implants Self closing intracranial aneurysm clips TISO 9713 ISO 11134 Sterilization of health care products Requirements for validation and routine control Industrial moist heat sterilization ISO 11134 ISO 11135 Medical devices Validation and routine control of ethylene oxide sterilization LAF TISO 11135 ISO 11137 Sterilization of health care products Requirements for validation and routine control Radiation sterilization IsO 11137 ISO 14630 Non Active surgical implants General requirements TISO 14630 ASTM F1058 Standard Specification for Wrought 40Cobalt 20Chromium 16Iron 15Nickel 7Molybdenum Alloy Wire and Strip for Surgical RM Applications UNS R30003 and UNS R30008 ASTM F1058 ASTM F2052 Standard Test Method for Measurement of eate Resonaric Environment ASTM F2052 EN 550 Sterilization of medical devices Validation and routine control of T oxide sterilization EN 550 EN 552 Sterilization of medical devices Validati
34. for Surgical Implant Applications UNS R30003 and UNS R30008 JE DigeMapari HEN JIS T 0993 1 ERROR 1 UR JIS T 7402 4 4 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 JIS T 7402 4 4 4 4 RANERO F l ISO 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 k Wrought 40Cobalt 20Chromium l6Iron 15Nickel 7Molybdenum Alloy Wire and Strip for Surg
35. a 3 JIS T 14971 16 169 5 _ JIS T 14971 mr Eire 4 9 JIS T 14971 6 l
36. ical Implant Applications UNS R30003 and UNS R30008 6 Mechanical Requirements JIS T 14971 e i 2 Xu JIS T 0993 1 1 3
37. on and routine control of sterilization by irradiation EN 552 EN 554 Sterilization of medical devices Validation and routine control of sterilization by moist heat LAF TEN 554 EN 556 1 Sterilization of medical devices Requirements for medical devices to be designated STERILE Requirements for terminally sterilized medical devices EN 556 1 3 S EN 556 2 Sterilization of medical devices Requirements for medical devices to be designated STERILE Part 2 Requirements for aseptically processed medical devices LAF TEN 556 2 z ISO 9713 3 1 v I E E 3 2 DRIER I VT RIRE X ANESEC C IBI LSU E BEETS D yn ESET 3 3 3 4 3 4 1 1 A ET ea c 1 B
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