인공관절의물리 기계적 시험방법가이드라인

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1) weight loss (mass loss) : 마모에의한물질의질량감소. - 6 -

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전치환경첩형 인공손가락관 절의표준규격 - 전치환경첩협인공손가락관절의기본적인요구사항을정 의하는표준규격 - 10 -

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2) 대퇴골오프셋 (femoral offset): 대퇴골두의중심과대퇴골장축간의거리 - 12 -

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Bencox Stem Bencox II Stem Bencox ID Stem Bencox ID Cemented Stem Bencox Cup, Bencox Ti- (TPS). Bencox Hybrid Cup Bencox Bipolar Cup B-P THR system Cementless Tapered Stem Cement Polished Tapered Stem 38~56mm. Ti-N 0.5~0.8mm Co-Cr - 15 -

DePuy DePuy BIOMET BIOMET BIOMET C-Stem AMT Total Hip System Corail Total Hip System Arcos Modular Femoral Revision System Taperloc Complete Hip Stem Taperloc Microplasty Hip Stems 3 700,000, 25. (HA ) 117 /,, 26 133, PPS Smith&Nephew Smith&Nephew Smith&Nephew DePuy DePuy AML Total Hip System Austin Moore Hemi-Arthropla sty 30 25-16 -

Stryker Stryker Stryker Stryker Smith&Nephew Restoration Modular Hip System Secur-Fit Exeter Accolade ECHELON Primary & Revision Cylindrical Revision Smith&Nephew Smith&Nephew Oxinium Head R3 Cup Oxinium Sticktite initial fiixation,, - 17 -

Stryker Stryker Stryker LOSPA Total Knee System B-P Total Knee system Triathlon Total Knee System Triathlon TS Knee Revision System HMRS/GMRS Replacement System 140 의깊은관절굴곡을위해확장된후방관절돌기디자인 Ti-N 세라믹 코팅기법사용 넓은범위의 IE rotation 가능, 높은굴곡각도보임 인공무릎관절 재치환술을위한 Triathlon line 과도한뼈손실 환자에게사용 Stryker Stryker Zimmer Zimmer Zimmer Zimmer Scorpio NRG Scorpio TS Knee Revision System Zimmer Gender Solutions NexGen High-Flex Knee NexGen LPS-Flex Mobile and LPS Mobile Bearing Knees Zimmer Unicompartmenta l High-Flex Knee System Single M/L Radius 로높은 굴곡각도를보임 인공무릎관절의재치환술을위한 Scorpio line - 18 -

Zimmer Zimmer Zimmer DePuy DePuy NexGen Complete Knee Solution Legacy Knee Posterior Stabilized LPS-Flex Fixed Bearing Knee Zimmer Gender Solutions Patello-Femoral Joint (PFJ) Zimmer Trabecular Metal CR/LPS Monoblock Tibia LCS Complete Knee System LCS Complete Revision Knee System - CR DePuy DePuy BIOMET BIOMET BIOMET LCS Complete Knee System LPS Limb Preservation System (Knee) Cementless Vanguard Complete Knee System E1 Antioxidant Infused Technology Vanguard Complete Knee System PS - 19 -

BIOMET Smith&Nephew Smith&Nephew Vanguard PFR Patellofemoral Replacement System Genesis ll Legion CR, PS, Constrained - 3 External rotation built in Oxinium type boxcut seemless - 20 -

Zimmer Zimmer BIOMET BIOMET DePuy Anatomical Shoulder System Anatomical Shoulder Fracture System Comprehensive Reverse Shoulder System Comprehensive Shoulder System Delta XTEND Reverse Shoulder System 3~4,, DePuy DePuy Stryker Stryker Smith&Nephew GLOBAL ADVANTAGE Shoulder Arthroplasty System GLOBAL AP Shoulder Arthroplasty System Solar Shoulder ReUnion HA Fracture System COFIELD 2-30 - 21 -

Stryker Stryker BIOMET Zimmer Solar Elbow System Discovery Elbow System Coonrad/ Morrey Total Elbow 24 // - 22 -

Ascension Orthopedics Ascension Orthopedics DePuy Ascension Orthopedics First Choice DRUJ System PyroCarbon Lunate Agility LP Total Ankle System CONSTRUCT Ankle Fusion Plating System 20 4.5, 6.5mm Ascension Orthopedics Ascension Orthopedics DePuy Wright Ascension Orthopedics Ascension PyroCarbon MCP Total Joint Ascension PyroCarbon PIP Total Joint NeuFlex MCP/PIP Finger Implant System LPT Great Toe Implant MOVEMENT Great Toe System. - 23 -

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δ γ 3) CAE (Computer Aided Engineering): 컴퓨터공학, 컴퓨터를이용한설계, 설계프로그램, 설계도면, 해석, 측정등을포괄적으로지칭하는단어. 4) 스템 (Stem): 인공고관절에서의스템은대퇴골부분에삽입되는줄기부분을통틀어말한다. - 26 -

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5) 대퇴골두 : 대퇴골근위부 ( 신체중심으로부터가까운쪽 ) 로구형모양이며, 스템에끼워져골반에들어가는비구컵과연결된다. - 29 -

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6) 정적장력 : 정적인상태에서당기는힘. 7) 골용해 (osteolysis): 뼈의용해와분해. - 31 -

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8) ISO14242-1 에정의된유체시험배지준비조건에따름 - 33 -

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9) 스페이서 : 나란히조립되는물품과물품사이의간격을고르게유지하기위하여그툼새에끼우는라이너. - 36 -

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모듈형헤드의결합및분리장치 - 48 -

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10) - 51 -

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11) 시상면 : 머리를측면에서바라본상태에서수직으로자른단면 - 59 -

12) 거골 : 위쪽은경골과비골, 아랫목은종골, 앞쪽은주상골에끼인족근골의하나. - 60 -

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13) UHMWPE(Ultra High Molecular Weight Polyethylene) : 초고분자량폴리에틸렌 - 65 -

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2012 8,,,,,,,,,,,,,, 363-700 2 187 : 043-719-4902~6 / 043-719-3951~67 : 043-719-4900 / 043-719-3950-75 -

363-700 2 187 TEL : 043)719-4903 FAX : 043)719-4900 http://www.kfda.go.kr, http://nifds.go.kr 내가지킨청렴실천모아지면청렴사회 - 76 -