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http://dx.doi.org/10.9718/JBER.2010.31.2.123

Research of Developing of Standards for Electronic Thermometers  

Kim, E.J. (Department, Fusion Technology Medical Devices Team, Pharmaceuticals and Medical Devices Research, National Institute of Food and Drug Safety Evaluation)
Lee, M.J. (Department, Fusion Technology Medical Devices Team, Pharmaceuticals and Medical Devices Research, National Institute of Food and Drug Safety Evaluation)
Lee, B.Y. (Department, Fusion Technology Medical Devices Team, Pharmaceuticals and Medical Devices Research, National Institute of Food and Drug Safety Evaluation)
Park, K.G. (Department, Fusion Technology Medical Devices Team, Pharmaceuticals and Medical Devices Research, National Institute of Food and Drug Safety Evaluation)
Kim, D.S. (Department, Fusion Technology Medical Devices Team, Pharmaceuticals and Medical Devices Research, National Institute of Food and Drug Safety Evaluation)
Lee, I.S. (Diagnostic Medical Devices Division, Korea Food & Drug Administration)
Park, H.D. (Diagnostic Medical Devices Division, Korea Food & Drug Administration)
Jeong, H.K. (Diagnostic Medical Devices Division, Korea Food & Drug Administration)
Publication Information
Journal of Biomedical Engineering Research / v.31, no.2, 2010 , pp. 123-128 More about this Journal
Abstract
The thermometers is widely used in diagnostic medical devices, and the safety and accurate performance of these devices are important in the diagnosis and monitoring of personal health. Especially, the accuracy of infra-red thermometer is highly emphasized. Here two typical thermometers are utilized for this purpose: the electronic thermometers measure body temperature by contacting to subject while infra-red thermometers measure by no contacting to subject. Therefore, the evaluating items of each thermometer are different, and the standard for each temperature is highly needed. But, there have been no international standards of each thermometer such as IEC. In this paper, we developed the standards of electronic and infra-red thermometer based on national standards such as KS, ASTM, EN, JIS and FDA guidance. The new standards focused on the safety and suitable performance for health care. This standards were applied to enact and revise the electronic medical device standards. So it can be applied to evaluate the safety and performance on technical file review. We predict that this standard will improve the quality of diagnostic medical devices (thermometers) and increase the international competitive power of domestic product.
Keywords
Standards; Thermometers; Safety; Performance;
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  • Reference
1 J Mercury Thermometers, A washington toxics coalition fact sheet, 1-2, May 2002 (http://watoxics.org/files/mercury-thennometers)
2 Karlinear J, Harvie J, HCWH Global mercury Team, The global movement for mercufy-free care, Health care, Health care without harm office(HCWH), (www.noharm.org) October 15, 2007
3 World Medical Association(WMA) statement on reducing the Global Burden of Mercury, Adopted by the WMA General Assembly, Seoul, Korea, October 2008 (http://www.wma.net/en/30publications/10policies/m36/index.html)
4 ASTM E1965 Standard specification of infrared thermometers of intermittent determination of patient temperature, 2003
5 Thermometers, Electronic, Infrared, Ear, ECRI. Healthcare Product Comparison System. 1-13, January 2003.
6 Romano, M. J., Fortenberry, J. D., Autrey, E., Hanis, S., Heyroth, T., Parmeter, P., and Stein, F., "Infrared Tympanic Thermometry in the Pediatric Intensive Care Unit," Critical Care Medicine, 21, pp. 1181-1185, 1993.   DOI   ScienceOn
7 JIS T 4207 Infrared ear thermometers, 2005
8 I. Pusnik, "Development of the ISO standard for clinical thermometers", IFMBE Proceedings 16, pp. 401-404, 2007
9 KS P6002 Clinical electrical thermometers with maximum device, 1992 (Reapproved 2004)
10 Erickson, R. S., and Meyer, L. T., "Accuracy of Infrared Ear Thermometry and Other Temperature Methods in Adults", Amer. J. of Critical Care, 3, pp. 40-54, 1994
11 Erickson, R. S., and Woo, T. M., "Accuracy of Infrared Ear Thermometry and Traditional Temperature Methods in Young Children", Heart & Lung, 23, pp. 181-195, 1994.
12 BS EN 12470-3 Clinical thermometers: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device, 2000
13 BS EN 12470-5 Clinical thermometers. Performance of infra-red ear thermometers (with maximum device), 2003
14 ASTM E1112 Standard Specification for Electronic Thermometer for intermittent determination of patient temperature, 2006
15 Committee Draft : IEC 62D/80601-2-56/Ed.1, Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement, 2008.
16 Ilsley, A. H., Rutten, A. J., and Runciman, W. B., "An Evaluation of Body Temperature Measurements," Anaesth. and Int. Care, 11, pp. 31-39, 1983.