Japanese Guidance for Ventricular Assist Devices/Total Artificial Hearts

被引：10

作者：

Yamane, Takashi ^{[1
,2
]}

Kyo, Shunei ^{[3
]}

Matsuda, Hikaru ^{[4
]}

Abe, Yusuke ^{[5
]}

Imachi, Kou ^{[5
]}

Masuzawa, Toru ^{[6
]}

Nakatani, Takeshi ^{[7
]}

Sase, Kazuhiro ^{[8
]}

Tabayashi, Koichi ^{[9
]}

Takatani, Setsuo ^{[10
]}

Tatsumi, Eisuke ^{[7
]}

Umezu, Mitsuo ^{[11
]}

Tsuchiya, Toshie ^{[12
]}

机构：

[1] Natl Inst Adv Ind Sci & Technol, Tsukuba, Ibaraki 3058564, Japan

[2] Pharmaceut & Med Devices Agcy, Tokyo, Japan

[3] Tokyo Univ Hosp, Tokyo 113, Japan

[4] Hyogo Univ Hlth Sci, Kobe, Hyogo, Japan

[5] Univ Tokyo, Grad Sch Med, Tokyo, Japan

[6] Ibaraki Univ, Grad Sch Engn, Hitachi, Ibaraki, Japan

[7] Natl Cardiovasc Ctr, Osaka, Japan

[8] Juntendo Univ, Sch Med, Tokyo 113, Japan

[9] Tohoku Univ, Grad Sch Med, Sendai, Miyagi 980, Japan

[10] Tokyo Med & Dent Univ, Tokyo, Japan

[11] Waseda Univ, Dept Adv Med Engn, Tokyo, Japan

[12] Natl Inst Hlth Sci, Tokyo, Japan

来源：

ARTIFICIAL ORGANS | 2010年 / 34卷 / 09期

关键词：

Guidance; Evaluation criteria; Ventricular assist device; Total artificial heart; SYSTEM RELIABILITY RECOMMENDATION;

D O I：

10.1111/j.1525-1594.2010.01091.x

中图分类号：

R318 [生物医学工程];

学科分类号：

0831 ;

摘要：

To facilitate research and development (R&D) and to expedite the review processes of medical devices, the Ministry of Health, Labor and Welfare (MHLW) and the Ministry of Economy, Trade and Industry (METI) founded a joint committee to establish guidance for newly emerging technology. From 2005 to 2007, two working groups held discussions on ventricular assist devices and total artificial hearts, including out-of-hospital programs, based on previous guidance documents and standards. Based on this discussion, the METI published the R&D Guidelines for innovative artificial hearts in 2007, and in 2008 the MHLW published a Notification by Director regarding the evaluation criteria for emerging technology.

引用

页码：699 / 702

页数：4

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