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授業科目名
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担当教員
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医療・福祉機器特論
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寺田 英嗣／牧野 浩二
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時間割番号
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単位数
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コース
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履修年次
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期別
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曜日
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時限
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| GTJ509 | 2 | (未登録) | 1,2 | 前期 | 月 | II | ||||||||||||
| ［概要と目標］ | ||||||||||||||||||
| [Advanced Medical and Welfare Devices] Medical and welfare devices must ensure not only the engineering aspects but also complete biological safety. To achieve this, it is essential to understand complex laws related to approval, certification, and business permits, as well as risk management, electrical safety, electromagnetic compatibility, and the complexities of the market. This course will cover various necessary aspects based on the needs of the medical and welfare fields in the process of developing new medical and welfare devices. Japanese is potentially used. 医療・福祉機器は工学の面からの機器だけでなく生物学的安全性を完全に担保した機器でなければならない．そのためには，複雑な承認・認証・業許可などの法律の理解，リスクマネジメント，電気安全・電磁両立性，複雑なマーケットの理解が必須となる．本講義では医療の現場、福祉の現場のニーズを基に，医療・福祉機器を新たに開発する過程において必要となる様々な事項に関して学ぶ．本講義は日本語を使用する． |
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(1) Be able to explain the safety assurance of medical and welfare devices. (2) Be able to plan clinical trials independently and prepare submission documents for the ethics committee. (3) Be able to explain the certification procedures for medical devices and welfare devices. (4) Be able to create the basic concept of a medical device independently. (1) 医療・福祉機器の安全確保が説明できる． (2) 臨床試験が自分で計画でき，倫理委員会への提出書類が作成できる． (3) 医療機器認証，福祉機器認証手続きが説明できる． (4) 医療機器の基本コンセプトを自分で作成することができる． |
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| ［必要知識・準備］ | ||||||||||||||||||
| It is assumed that students understand and can perform calculations and explanations based on the fundamental courses in mechanical, electrical, and information engineering at the undergraduate level. Additionally, some of the papers to be studied may be in English. Students are expected to review these materials on their own. 学部における機械・電気・情報の基礎的授業を理解し，計算・説明できることを前提としている．また，取り扱う論文は英語の場合もある．各自復習しておくこと． |
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| ［講義項目］ | ||||||||||||||||||
| Please note that lectures will be given online every Wednesday from 6:00 p.m. to 9:00 p.m., except for the 1st and 15th lectures. Please note that the schedule is subject to change due to medical treatment, so please pay attention to the bulletin boards of the CNS and other medical institutions. Only students with excellent grades in this course will be allowed to attend the second semester of the Medical Device Development Human Resource Development Course. Orientation and Basic Medical Lecture and Related Medical Devices (1) Emergency Medicine Basic Medical Lecture and Related Medical Devices (2) Introduction to Medical Devices Basic Medical Lecture and Related Medical Devices (3) Dentistry and Oral Surgery Basic Medical Lecture and Related Medical Devices (4) Orthopedics Basic Medical Lecture and Related Medical Devices (5) Anesthesiology Basic Medical Lecture and Related Medical Devices (6) Radiology and Endocrinology Basic Medical Lecture and Related Medical Devices (7) Pediatrics Basic Medical Lecture and Related Medical Devices (8) Otolaryngology and Head and Neck Surgery Basic Medical Lecture and Related Medical Devices (9) Cardiology Basic Medical Lecture and Related Medical Devices (10) Diabetology Basic Medical Lecture and Related Medical Devices (11) Urology Basic Medical Lecture and Related Medical Devices (12) Ophthalmology Basic Medical Lecture and Related Medical Devices (13) Gastroenterology Medical Device Malfunction Reporting System and Safety Management Overview of Medical Device Laws and Comprehensive Evaluation The goal is to understand the content of each lecture. 第1回，第15回を除き，4/23-6/11の毎週水曜18時～21時にオンライン講義となるので注意すること．なお診療の関係で日時は変更されることがある．CNS等の掲示に注意すること． また本講義の成績優秀者のみ，後期の医療機器開発人材養成講座の受講が許される． 暫定スケジュール（変更の可能性あり，CNS掲示に注意） １．オリエンテーション・医学基礎講座と関連医療機器(1) 救急領域 ２．医学基礎講座と関連医療機器(2) 医療機器概論 ３．医学基礎講座と関連医療機器(3) 歯科・口腔外科領域 ４．医学基礎講座と関連医療機器(4) 整形外科領域 ５．医学基礎講座と関連医療機器(5) 麻酔科領域 ６．医学基礎講座と関連医療機器(6) 放射線科内分泌内科領域 ７．医学基礎講座と関連医療機器(7) 小児科領域 ８．医学基礎講座と関連医療機器(8) 耳鼻咽喉科・頭頚部外科領域 ９．医学基礎講座と関連医療機器(9) 循環器内科領域 10．医学基礎講座と関連医療機器(10) 糖尿病内科領域 11．医学基礎講座と関連医療機器(11) 泌尿器科領域 12．医学基礎講座と関連医療機器(12) 眼科領域 13．医学基礎講座と関連医療機器(13) 消化器領域 14．医療機器の不具合報告制度 医療機器の安全管理 15．医療機器法律概論および総合評価 各回の講義内容について理解することを到達目標とする． |
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| ［前年度授業に対する改善要望等への対応］ | ||||||||||||||||||
| 特に対応すべき点はない． | ||||||||||||||||||