Technical Brief

Cost-Effective Reliability Analysis and Testing of Medical Devices1

[+] Author and Article Information
Lori Lucke, John Whitehurst

Minnetronix, Inc.,
St. Paul, MN 55108

Accepted and presented at the Design of Medical Devices Conference (DMD2014), Minneapolis, MN, April 7–10, 2014.DOI: 10.1115/1.4027105

Manuscript received February 21, 2014; final manuscript received March 3, 2014; published online July 21, 2014. Editor: Arthur G. Erdman.

J. Med. Devices 8(3), 030911 (Jul 21, 2014) (2 pages) Paper No: MED-14-1111; doi: 10.1115/1.4027105 History: Received February 21, 2014; Revised March 03, 2014

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Department of Health and Human Services, 2005, “Code of Federal Regulations Title 21, Part 803: Medical Device Reporting,” U.S. Food and Drug Administration, Washington, DC.
Department of Health and Human Services, 2005, “Code of Federal Regulations Title 21, Part 820: Quality System Regulation,” U.S. Food and Drug Administration, Washington, DC.
Council of the European Communities, 1993, “Medical Devices Directive 93/42/EEC,” Official Journal of European Communities, No L 169/1.
FDA Design Control Guidance for Medical Device Manufacturers, March 11, 1997.
Kececioglu, D., and Sun, F. B., 2003, Environmental Stress Screening, DEStech Publications, Inc., Lancaster, PA.
Mak, T. M., 2007, “Infant Mortality—The Lesser Known Reliability Issue,” 13th IEEE International On-Line Testing Symposium (IOLTS 07), Crete, Greece, July 8–11. [CrossRef]
O'Conner, P., and Kleyner, A., 2012, Practical Reliability Engineering, Wiley, New York.
Fries, R. C., 2006, Reliable Design of Medical Devices, 2nd ed., CRC Press, Boca Raton, FL.


Grahic Jump Location
Fig. 1

Stress testing and analysis to improve design

Grahic Jump Location
Fig. 2

Life prediction curve

Grahic Jump Location
Fig. 3

Vibration analysis

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Fig. 4

Manufacturing flow

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Fig. 5

Failure analysis: showing cycles per unit to failure



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