2024-08-27

医療機器のHFE/UEに関する書籍

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医療機器のHFE/UEに関する書籍

この記事では、医療機器のHFE/UEに関する書籍として、どのようなものがあるか少しだけご紹介したいと思います。欧米では医療機器へのHFE/UEの適応は何十年も前年から議論されるようになり、既に幾つかの書籍が発行されています。ただ、残念ながら日本語の書籍は私の知る限りありません。英語の書籍になりますが、ぜひこの分野に携わるのであれば知っていただきたい、一読いただきたい書籍を厳選して少しだけご紹介いたします。以下の書籍です。


Applied Human Factors in Medical Device Design

Edited by: Mary Beth Privitera

https://www.sciencedirect.com/book/9780128161630/applied-human-factors-in-medical-device-design


Contextual Inquiry for Medical Device Design

By: Mary Beth Privitera

https://www.sciencedirect.com/book/9780128018521/contextual-inquiry-for-medical-device-design


Risk Management: How to Assess and Control Risk Related to Human Error in Products and Systems

By: Edmond W. Israelski, William H. Muto

https://www.hfes.org/Publications/Books/Risk-Management


User Interface Requirements for Medical Devices: Driving Toward Safe, Effective, and Satisfying Products by Specification

By: Michael Wiklund, Erin Davis, Alexandria Trombley

https://www.routledge.com/User-Interface-Requirements-for-Medical-Devices-Driving-Toward-Safe-Effective-and-Satisfying-Products-by-Specification/Wiklund-Davis-Trombley/p/book/9780367457471


Usability Testing of Medical Devices – Second Edition

By: Michael E. Wiklund P.E., Jonathan Kendler, Allison Y. Strochlic

https://www.taylorfrancis.com/books/mono/10.1201/b19082/usability-testing-medical-devices-jonathan-kendler-michael-wiklund-allison-strochlic


Medical Device Use Error – Root Cause Analysis

By: Michael Wiklund, Andrea Dwyer, Erin Davis

https://www.routledge.com/Medical-Device-Use-Error-Root-Cause-Analysis/Wiklund-Dwyer-Davis/p/book/9781498705790


Medical Product Development: : Meeting FDA’s Human Factors Expectations

By: Michael Wiklund

https://www.hfes.org/Publications/Books


Writing Human Factors Plans & Reports for Medical Technology Development

By: Michael Wiklund, Laura Birmingham, and Stephanie Alpert Larsen

https://array.aami.org/doi/abs/10.2345/9781570206894.ch1


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