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4.2.3 A Systems Approach to Medical Device Compliance with IEC 60601–1:2005
Author(s) -
Gibson Chad,
Eubanks Fritz,
Hobson Felicia
Publication year - 2012
Publication title -
incose international symposium
Language(s) - English
Resource type - Journals
ISSN - 2334-5837
DOI - 10.1002/j.2334-5837.2012.tb01352.x
Subject(s) - clinical engineering , risk analysis (engineering) , usability , medical equipment , computer science , reliability engineering , engineering , systems engineering , engineering management , business , medicine , health care , nursing , human–computer interaction , economics , economic growth
The development of electrical medical devices requires compliance with a host of regulations and standards to help ensure their safety and effectiveness. One of the most notable additions in recent years is the 3 rd Edition of IEC 60601‐1 (IEC 60601–1, 2005), “Medical electrical equipment – General requirements for basic safety and essential performance.” Medical devices sold to the European Community and Canada must comply with the standard in 2012, and devices in the U.S. and other countries must follow shortly thereafter. This standard represents a sea change in the way medical devices are typically developed, and includes a heavy reliance on safety risk management and usability engineering processes. This paper presents the systems engineer as the ideal candidate to lead these activities and facilitate device development; the standard impacts many areas (e.g., engineering, regulatory, human factors, and project management) and requires a methodical approach to implement in a cost‐effective manner while ensuring safety and effectiveness of the device. This paper details techniques developed to efficiently comply with the standard, leveraging existing systems engineering practices and emerging methods such as Model Based Systems Engineering.