Durability testing of a completely implantable electric total artificial heart.
Durability testing of a completely implantable electric total artificial heart.
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完全植入式电动全人工心脏的耐久性测试。
DOI:
10.1097/01.mat.0000159385.32989.7c
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发表时间:
2005
期刊:
影响因子:
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通讯作者:
Rosenberg,Gerson
中科院分区:
文献类型:
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作者:
Zapanta,ConradM;Snyder,AlanJ;Weiss,WilliamJ;Cleary,ThomasJ;Reibson,JohnD;Rawhouser,MarjorieA;Lewis,JeffreyP;Pierce,WilliamS;Rosenberg,Gerson
In vitro durability testing was conducted on the Penn State/3M electric total artificial heart (ETAH) to determine device durability and to evaluate device failures. A specialized mock circulatory loop was developed for this testing. Customized software continuously acquired data during the test period, and failures were analyzed using FMEA (failure modes and effects analysis) and FMECA (failure modes, effects, and criticality analysis) principles. Redesigns were implemented when appropriate. Reliability growth principles were then applied to calculate the 1 and 2 year reliability. The 1 and 2 year reliability of the Penn State/3M ETAH was shown to be 96.1% and 59.9%, respectively, at 80% confidence.