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Contents
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426. 1 ISO 14242 1 Implants for surgery Wear of total hip joint prostheses Part 1 Loading and 2 3 4 5 displacement parameters for wear testing machines and corresponding environmental conditions for test 2002 ISO 14242 2 Implants for surgery Wear of total hip joint prostheses Part 2 Methods of measurement 2000 Thomas P Schmalzried MD et al The multifactorial nature of polyethylene wear in vivo J Bone Joint Surg 80A 8 1234 1243 1998 Dumbleton JH Manley MT et al A literature review of the association between wear rate and osteolysis in total hip arthroplasty J Arthroplasty 17 5 649 661 2002 Manley MT Dumbleton J Bearing surface In Barrack RL Booth RE et al Ed Orthopaedic Knowledge Update Hip and Knee Reconstruction 3 American Academy of Orthopaedic Surgeons 333 344 2002 59 D D 1
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515. industrial automation applications Industrial robot or manipulating industrial robot automatically controlled reprogrammable multipurpose manipulator programmable in three or more axes which may be either fixed in place or mobile for use in industrial automatton applications IEC robot robotic device autonomy IEC 1 Robots and robotic devices to establish a new Joint Working Group on Safety for medical devices using robotic technology robotic technology robotic technology robot IEC 60601 1 1 1 88
516. of the Estrogen Responsive Genes in Response to Phytoestrogens Using a Customized DNA Microarray FEBS Lett 579 1732 1740 Terasaka S Inoue A Tanji M and Kiyama R 2006 Expression profiling of estrogen responsive genes in breast cancer cells treated with alkylphenols chlorinated phenols parabens or bis and benzoylphenols for evaluation of estrogenic activity Toxicol Lett 163 130 141 Dong S Inoue A Zhu Y Tanji M and Kiyama R 2007 Activation of rapid signaling pathways and the subsequent transcriptional regulation for the proliferation of breast cancer MCF 7 cells by the treatment with an extract of glycyrrhiza glabra root Food Chem Toxicol 45 2470 2478 Parveen M Inoue A Ise R Tanji M and Kiyama R 2008 Evaluation of estrogenic activity of phthalate esters by gene expression profiling using a focused microarray EstrArray Environ Toxicol Chem 27 1416 1425 Parveen M Zhu Y and Kiyama R 2009 Expression profiling of the genes responding to zearalenone and its analogues using estrogen resDonsive genes FEBS Letters 583 2377 2384 Dong S and Kiyama R 2009 Characterization of estrogenc activity of gmnsenosides in MCE 7 cells using a customized DNA microarray Food Chem 113 672 678 Xu Q Hamada T Kiyama R Sakuma Y and Wada Kiyama Y 2008 Site specific regulation of gene expression by estrogen in the hypothalamus of adult female rats Neurosc
517. steel ISO 5832 2 Implants for surgery Metallic materials Part 2 Unalloyed titanium ISO 5832 3 Implants for surgery Metallic materials Part 3 Wrought ttanium 6 aluminum 4 vanadium alloy ISO 5832 11 Implants for surgery Metallic materials Part 11 Wrought titanium 6 aluminium 7 niobium alloy ISO 7153 1 Surgical instruments Metallic materials Part 1 Stanless steel ASTM A276 Standard Specification for Stainless Steel Bars and Shapes ASTM EF67 Standard Specification for Unalloyed Titanium for Surgical Implant Apphcations UNS R50250 UNS RS50400 UNS R50550 UNS RS0700 ASTM F7S Standard Specification for Cobalt 28Chromium 6 Molybdenum Alloy Castings and Castng Alloy for Surgical Implants UNS R30075 ASTM F90 Standard Specificaton for Wrought Cobalt 20Chtomium 1STungsten 10Nickel Alloy for Surgical implant Apphcations UNS R30605 ASTM F136 Standard Specification for Wrought Titanium 6Aluminum 4Vanadium ELI Extra Low Intersttial Alloy for Surgical Implant Apphcations UNS RS6401 ASTM F138 Standard Specification for Wrought 18Chromium 14Nickel 2 3 Molybdenum Stainless Steel Bar and Wire for Surgical Implants UNS S31673 ASTM F139 Standard Specification for Wrought 18Chromium 14Nickel 2 3 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants UNS S31673 ASTM F620 Standard Specification for Alpha Plus Beta Titantum Alloy Forgings for Surgical TImplants ASTM F621 Standard Specification for Stainless
518. 09 Good responder 7896 900 Good responder 700 900 responders 3 lt 4 Q Responder Nonresponder A Pre Pre Pre
519. 2 000 Q Web Ai Direct to Consumer Test Q JMAC ISO A ISO TC34 TC212 FGED ISO 187 Q Ai 5 9 LDT Q LDT A
520. 7 3 31 0331038 15 2 13 0213001 15 3 19 No 36 20 10 8 1008001 20 8 4 0804001 21 3 6 0306001 70 3 2008
521. A DNA sDNA RT PCR RT PCR RTPCR FDA 510 k RNA EN 13640 2002 RNA 2004 CLSI
522. CBER Martn Ruta 301 827 3518 in vitro http www fda gov cdrh oivd guidance 1610 pdf http www fda gov cber guidelines htm dsmica fda hhs gov 240 276 3151 1610 HFM 40 1401 Rockville Pike Suite 200N Rockville MD 20852 1448 800 835 4709 301 827 1800 FDA in vitro
523. I Special Controls Guidance Document RNA Preanalytical Systems RNA Collection Stabilization and Purification Systems for RT PCR used in Molecular Diagnostic Testing August 25 2005 21 3 4 6 7 DRAFT GUIDANCE Pharmacogenomic Data Submissions August 24 2007 7 7 1 Development guidelines 2007 Diasnostic device for personalized medicine DNA microarrays DNA microarray for genotyping May 2007 Ministry of Economy Trade and Industry 7 2 DNA 2007 DNA 19 5 5 EFDA IVDMIA 21 3 4 a
524. IV 4 C C IV 4 6 22 WG 142 IV 19 xx IV 4 IV 4 lt xx IV
525. Implants for surgery Measurements of open circult potential to assess corrosion behavior of metalhc implantable materials and medical devices over extended time periods 4 48 4 1 custom made artificial hip joint prostheses A B tailor made order made 5S 1 1 3
526. NA 2007 OECD GLP 2009 ISO Microarray General definition minimum requirement ISO CEN MAQC MAQC I MAQC TI MAQC FDA RNA RNA 1 IVDMIA 510 K PMA PGx Data Submissions Guideline ERCC OECD GLP Heritable Disease and Condition ISO
527. Steel Forgings for Surgical Implants ASTM F648 Standard Specification for Ultra High Molecular Weight Polyethylene Powder and Fabricated Form for Surgical Implants ASTM F799 Standard Specification for Cobalt 28Chromium 6Molybdenum Alloy Forgings for Surgical Implants UNS R31537 R31538 R31539 ASTM F1091 Standard Specification for Wrought Cobalt 20Chromium 1Stungsten 73 10Nickel Alloy Surgical Fixaton Wire UNS R30605 27 ASTM F1314 Standard Specification for Wrought Nitrogen Strengthened 22Chromium 13Nickel SManganese 2 SMolybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants UNS S20910 28 ASTM F1472 Standard Specification for Wrought Titantum 6Alummum 4Vanadium Alloy for Surgical Implant Apphcatons UNS RS6400 74 1 Uncemented custom femoral components in hip arthroplasty Aprospective clinical study of 191 hips followed for at least 7 years Acta Orthopaedica 2010 BenumPetal 1
528. T PCR Brast C PGx OECD ls O O O O O 178 O 2 Oo Oo 0 O Oo 90 110 O O O O WM Mr O O O i O Oo Oo O O RNA Oo RNA 2 RNA O O A260 RNA oO a O Oo RNA A260 280 A260 280 2 Oo oO 28S 18S 28s 18s DNA Nx 2 O O DNA 2 O DNA 8 DNA EL O Oo Oo O DNA o o O DNA O Oo O oO Oo 0 39 O O EE O
529. blishment of allowable limits for leachable substances ISO 10993 18 Biological evaluation of medical devices Part 18 Chemical characterization of materials JIS T 0993 1 1 JIS T 0301 TS T 0011 ASTM F1350 Standard Specification for Wrought 18Chromium 14Nickel 2 5 Molybdenum Stainless Steel Surgical Fixation Wire UNS S31673 ASTM F1537 Specification for Wrought Cobalt 28Chromium 6Molybdenum Alloys for Surgical Implants UNS R31537 UNS R31538 and UNS R31539 72 3 3 6 8 10 dD d2 13 dN 15 16 1 18 19 20 21 22 23 2 25 26 JIS G 4303 JIS G 4305 JIS G 4308 JIS G 4309 JIS G 4314 JIS G 4315 JIS H 4600 JIS H 4650 JIS H 4670 ISO 5832 1 Implants for surgery Metallic materials Part 1 Wrought stainless
530. cessed 2011 03 23 I 2010 11 URL http Wwww jacvas com standard_i html Accessed 2011 03 23 I I Ni a i a 4 5 117 SAMPLE1 22 2011 3 118
531. devices Part 4 Selecuon of tests for interacthons with blood ISO 10993 3 Biological evaluation of medical devices Part 5 Tests for in vitro cytotoxicity ISO 10993 6 Biological evaluation of medical devices Part 6 Tests for local effects after implantaton ISO 10993 7 Biological evaluation of medical devices Part 7 Ethylene oxide sterilhzation residuals ISO 10993 9 Biological evaluaton of medical devices Part 9 Framework for identification and quantification of potential degradation products ISO 10993 10 Biological evaluation of medical devices Part 10 Tests for irritanon and delayed type hypersenslhvity ISO 10993 11 Biological evaluation of medical devices Part 11 Tests for systemnc toxicity ISO 10993 12 Biological evaluaton of medical devices Part 12 Sample preparation and reference materials ISO 10993 13 Biological evaluation of medical devices Part 13 Identification and quantification of degradation products from polymeric medical devices ISO 10993 14 Biological evaluation of medical devices Part 14 Identification and quantification of degradation products from ceramics ISO 10993 15 Biological evaluation of medical devices Part 15 Identification and quantification of degradation products from metals and alloys ISO 10993 16 Biological evaluation of medical devices Part 16 Toxicokinetic study design for degradation products and leachables ISO 10993 17 Biological evaluation of medical devices Part 17 Esta
532. dified organisms and derived products 2010 NWIP CD General definitions and requirements for microarray detection of specific nucleic acid sequence 168 MAQC I MAQC II Class II RNA Analysis PCR IVDMIA Breast Cancer Prognosis PGxDS DNA DNA OECD GLP for for Molecular Genetic Testing ISO Methods of analysis for GMO detection NWIP sPIDIA SPIDIA 2008 11 16 7 8 4 in vitro 2010 AMP 2010
533. ertrophy in Gruen zone 2 6 3 16 3 37 or6 7 amp X 2 79 6 The Custom Femoral Component is an Effective Option for Congenital Hip Dysplasia Clinical Orthopaedics and Related Research 2006 Takashi Sakaietal 1 Fit and fill custom 2 7 11 54 40 73 OA 99 Crowe L III 1994 1997 3D CTbased 6A1l4V grooves sand blasted modular neck7head 121 mm 103 135 mm F U 9 years 7 11 99 survival HHS
534. ging 100 5 22 Vol 26 No 6 pp 747 752 29 WG 2006 http www journalarchive jst go jp jnlpdf php cdjournal jaem1993 amp cdvol 26 amp noissue 6 amp startpage 74 T amp lang ja amp from jnltoc 155 VI B Yes No A B C D 1 2 C Q C amp
535. hopedic Fracture Fixation Devices ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws ASTM F2180 Standard Specification for Metalhc hmplantable Strands and Cables ISO 2153S5 Non actve surgical implants Joint replacement implants Specific requirements for hip jolnt replacement implants ISO 7206 1 8 Hmplants for surgery Partal and total hip jolnt prostheses ISO 14242 1 7 hmplants for surgery Wear of total hip jolnt prostheses ISO 5838 1 hmplants for surgery Skeletal pins and wires Part 1 Material and mechanical reduirements ASTM F366 Standard Specification for Fixation Pins and Wires ISO 8827 Implants for surgery Staples with parallel legs for orthopaedic use General reduirements ASTM ES8 ESMLStandard Test Methods for Tension Testing of Metalhc Materials ISO 6507 1 4 Metallic materials Vickers hardness test 71 2 3 3 8 10 dD 12 13 dN 15 16 1 18 19 20 21 22 ISO 10993 1 Biological evaluaton of medical devices Part 1 Evaluation and testing within a risk management process ISO 10993 2 Biological evaluation of medical devices Part 2 Animal welfare requirements ISO 10993 3 Biological evaluation of medical devices Part 3 Tests for genotoxicity carcinogenicity and reproductive toxicity ISO 10993 4 Biological evaluation of medical
536. i Letts 436 35 39 243 5 3 DNA DNA RNA 1 3 1 1 3 2 MAQC II 1 JMAC DNA 1 2 DNA
537. nt 185 Pathwork Tissue of Origin test Laboratory Development Test RT PCR DTC Direct To Consumer test Web Oncotype DX 21 RT PCR Pathwork 15 FDA FDA Known Valid Biomarkers Probable Valid Biomarkers Exploratory Biomarkers 3 Biomarkers CYP2C9 CYP2C19 Valid Biomarkers Valid Biomarkers mutation SPIDIA MAQC I II FDA Muldvariate Index Assay IVD PGx Data Submission D
538. r traning 7 2003 8 2007 4 4 1 22 WG 21 ISO 10015
539. sisted Detectton Devices Apphed to Radiology Images and Radiology Device Data Premarket Approval PMA and Premarket Notification 510 k Submissions 12 GHTF 13 GHTF 248 14 GHTF STED 15 1 2 3 4 CAD
540. w kokken go jp byoin Accessed 2011 02 20 116 L Fr 1 1 2 2
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