植込み型補助人工心臓システムEVAHEARTの耐久性評価

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Published in生体医工学 Vol. 49; no. 6; pp. 918 - 924
Main Authors 北野, 智哉, 宮越, 貴之, 小林, 信治, 得能, 敏正, 山崎, 健二, 岩崎, 清隆, 梅津, 光生
Format Journal Article
LanguageJapanese
Published 公益社団法人 日本生体医工学会 10.12.2011
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Author 山崎, 健二
小林, 信治
得能, 敏正
梅津, 光生
岩崎, 清隆
北野, 智哉
宮越, 貴之
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  fullname: 宮越, 貴之
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  fullname: 小林, 信治
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  fullname: 得能, 敏正
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  fullname: 山崎, 健二
  organization: 東京女子医科大学心臓血管外科
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  fullname: 岩崎, 清隆
  organization: 早稲田大学理工学術院先進理工学研究科
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  fullname: 梅津, 光生
  organization: 早稲田大学理工学術院先進理工学研究科
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References 8. Long-term mechanical circulatory support system reliability recommendation:American Society for Artificial Internal Organs and The Society of Thoracic Surgeons, George M. Pantalos et al. Annual Thoracic Surgery. 66:1852-1859, 1998.
2. CDRH Circulatory Support Devices Panel, March 4 2002, Thoratec HeartMate VE LVAS, P920014/S016, http://www.fda.gov/ohrms/dockets/ac/02/slides/3843s1.html(URL)[Accessed Jun 1, 2011]
6. 翁・梅原・加藤・新居:水潤滑セラミックス軸受けの基礎研究. 日本機械学会論文集(C編). 61(590):4027-4032, 1995.
5. Yamazaki K, et al:Completely pulsatile high flow circulatory support with constant-speed centrifugal blood pump:mechanism and early clinical observations. Gen Thorac Cardiovascu Surg. 55:158-162, 2007.
7. 体内埋め込み型能動型機器分野(高機能人工心臓システム)開発ガイドライン2007, 経済産業省.
4. ISO14971:2007 Medical devices—Application of risk management to medical devices.
9. Cumulative Binomial for Test Design and Analysis, Reliability Edge, http://www.reliasoft.com/newsletter/2q2001/cumulative_binomial.htm[Accessed Sep 1, 2011]
3. Sonna M. Patel, et al:Method of failure and reliability assessment for mechanical heart pumps. Artificial Organs. 29(1):15-25, 2005.
1. 臓器移植ファクトブック2009, 日本移植学会広報委員会, http://www.asas.or.jp/jst(URL)[Accessed Jun 1, 2011]
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Title 植込み型補助人工心臓システムEVAHEARTの耐久性評価
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