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9291.pdf (6.9 MB)
ETD Abstract Container
Abstract Header
Defining the Industrial Designer's Role in the ISO/IEC 62366 Standard
Author Info
Alley, Krista I
Permalink:
http://rave.ohiolink.edu/etdc/view?acc_num=ucin1397235614
Abstract Details
Year and Degree
2014, MDES, University of Cincinnati, Design, Architecture, Art and Planning: Design.
Abstract
In recent years, the medical device industry has revised its development practices by incorporating the ISO/IEC 62366 (Usability Engineering Process) standard. The standard, purposed to guide industry toward achieving reasonable usability in all medical devices and reduce use errors, heavily emphasizes risk management and has created a large need for usability research and an in-depth understanding of human factors. A common misconception exists that the complexity of identifying, mitigating, and testing for such risk is beyond the usability and human factors components of tradition industrial design. As a result, medical device design teams typically rely on human factors engineers, and in many cases where both disciplines are present, have consequently grayed the understanding of team roles concerning usability engineering. By surveying and performing case studies on design processes used in medical device design, this thesis examines the role of the industrial designer and suggests the best practices for industrial design within the ISO/IEC 62366 standard.
Committee
Steven Doehler, M.A. (Committee Chair)
Edwin Bills, M.Ed. (Committee Member)
Soo-Shin Choi, M.F.A. (Committee Member)
Tony Kawanari, M.A. I.D. (Committee Member)
Pages
50 p.
Subject Headings
Design
Keywords
Medical Devices
;
Medical Device Design
;
Industrial Design
;
Usability Engineering
;
Standardization
;
ISO IEC 62366
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Citations
Alley, K. I. (2014).
Defining the Industrial Designer's Role in the ISO/IEC 62366 Standard
[Master's thesis, University of Cincinnati]. OhioLINK Electronic Theses and Dissertations Center. http://rave.ohiolink.edu/etdc/view?acc_num=ucin1397235614
APA Style (7th edition)
Alley, Krista.
Defining the Industrial Designer's Role in the ISO/IEC 62366 Standard.
2014. University of Cincinnati, Master's thesis.
OhioLINK Electronic Theses and Dissertations Center
, http://rave.ohiolink.edu/etdc/view?acc_num=ucin1397235614.
MLA Style (8th edition)
Alley, Krista. "Defining the Industrial Designer's Role in the ISO/IEC 62366 Standard." Master's thesis, University of Cincinnati, 2014. http://rave.ohiolink.edu/etdc/view?acc_num=ucin1397235614
Chicago Manual of Style (17th edition)
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Document number:
ucin1397235614
Download Count:
1,541
Copyright Info
© 2014, all rights reserved.
This open access ETD is published by University of Cincinnati and OhioLINK.