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ファイル
Contents
1. JIS T 14971 JIS T 0993 1 T Bg 32. JIS T 14971 5 1 17 3 10 0310003 5 16 17 2 16 BBE OB TO 1 38 4835 35 WB E OAL BRE SERERE 0216002 2 1 L 2
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14. JIS T 0993 1 BERGER 1 JIS T 0993 1 E Ja JIS T 7402 4 4 JIS T 7402 4 JIS T 14971 JIS T 14971 De 17 3 30 0330001 GMP QMS 4 4 ISO 5832 7 Implants for surgery Metallic materials Part 7 Forgeable and cold formed cobalt chromium ni ckel molybdenum iron alloy LAF TISO 5832 7
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30. 4 ISO 5832 7 Implants for surgery Metallic materials Part 7 Forgeable and cold formed cobalt chromium nickel molybdenum iron 7 alloy Introduction ASTM F1058 Standard Specification for Wrought 40Cobalt 20Chromiuni 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 i35 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 for Wrought 40Cobalt 20Chromium l6Iron 15Nickel 7Molybdenum Alloy Wire and Strip for Surgical Implant Applications UNS R30003 and UNS R30008 6 Mechanical Requirements 2
31. ISO 9713 Neurosurgical implants Self closing intracranial aneurysm clips EAF TISO 9713 ISO 11134 Sterilization of health care products Requirements for validation and routine control Industrial moist heat sterilization LAF TISO I1134 ISO 11135 Medical devices Validation and routine control of ethylene oxide sterilization LAF ISO 11135 ISO 11137 Sterilization of health care products Requirements for validation and routine control Radiation sterilization LAF TISO 11137 ISO 14630 Non Active surgical implants General requirements IS0 14630 ASTM F1058 Standard Specification for Wrought 40Cobalt 20Chromium 161ron 15Nickel 7Molybdenum Alloy Wire and Strip for Surgical Implant Applications UNS R30003 and UNS R30008 LAF TASTM F1058 5 ASTM F2052 Standard Test Method for Measdreneni of Magnetic ResonanceEnvironment ASTM F2052 EN 550 Sterilization of medical devices Validation and routine control of ethylene oxide sterilization LAF TEN 550 EN 552 Sterilization of medical devices Validation and routine control of sterilization by irradiation LAF TEN 552 EN 554 Sterilization of medical devices Validation and routine control of sterilization by moist heat PAF TEN 55
32. 7 NATOS eid NUT NERONI aa te et as FERUTA JIS T 0993 1 1 dus 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 16I ron 15Nickel 7Molybdenum Alloy Wire and Strip for Surgical Implant Applications UNS R30003 and UNS R30008 X2 Biocompatibility IL JIS T 0993 1 1 JIS T 7402 4
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41. 9 2 5 ISO 9713 1 2 3 3 3 4 5 mm 60 T 8 3 6 2 3 6 1 9 3 4 1 10 SER 11
42. 4 EN 556 1 Sterilization of medical devices Requirements for medical devices to be designated STERILE Requirements for terminally sterilized medical devices EN 556 1 EN 556 2 Sterilization of medical d vices Reduirements for medical devices to be designated STERILE Part 2 Requirements for aseptically processed medical devices EN 556 2 ISO 9713 3 1 m 3 2 BREMEN UV BEER UR ATA X VL IC SU VC pti OO MAGEN BIE A ZU V L 3 3 3 4 3 4 1 1 A 3 4 2 1 B 3 4 3 1 C
43. C FR LC RAT SRA ROR SOR Ue RIE 7 WEBER FRITS RRR BA ROMER A i i 8
44. n ASTM F1058 ISO 5832 7 Implants for surgery Metallic materials Part 7 Forgeable and cold formed cobalt chromium nickel molybdenum iron Standard Specification for Wrought 40Cobalt 20Chromium 16 ron 15Nickel 7Molybdenum Alloy Wire and Strip for Surgical Implant Applications UNS R30003 and UNS R30008 6 eo E E
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