Journal of Biomedical Engineering Research (대한의용생체공학회:의공학회지)

The Korean Society of Medical and Biological Engineering (대한의용생체공학회)
권호 표지
DOI QR코드

DOI QR Code

Research of Developing of Standards for Electronic Thermometers

전자식체온계 기준규격 개발 연구

  • 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)
  • 김은주 (식품의약품안전평가원 의료제품연구부 융합기기팀) ;
  • 이민정 (식품의약품안전평가원 의료제품연구부 융합기기팀) ;
  • 이병영 (식품의약품안전평가원 의료제품연구부 융합기기팀) ;
  • 박기정 (식품의약품안전평가원 의료제품연구부 융합기기팀) ;
  • 김동섭 (식품의약품안전평가원 의료제품연구부 융합기기팀) ;
  • 이인수 (식품의약품안전청 의료기기심사부 진단기기과) ;
  • 박해대 (식품의약품안전청 의료기기심사부 진단기기과) ;
  • 정희교 (식품의약품안전청 의료기기심사부 진단기기과)
  • Received : 2009.12.02
  • Accepted : 2010.04.07
  • Published : 2010.04.30
Download PDF
⟨ Previous Next ⟩

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

References

  1. 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)
  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. J Mercury Thermometers, A washington toxics coalition fact sheet, 1-2, May 2002 (http://watoxics.org/files/mercury-thennometers)
  4. Thermometers, Electronic, Infrared, Ear, ECRI. Healthcare Product Comparison System. 1-13, January 2003.
  5. ASTM E1112 Standard Specification for Electronic Thermometer for intermittent determination of patient temperature, 2006
  6. ASTM E1965 Standard specification of infrared thermometers of intermittent determination of patient temperature, 2003
  7. BS EN 12470-3 Clinical thermometers: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device, 2000
  8. BS EN 12470-5 Clinical thermometers. Performance of infra-red ear thermometers (with maximum device), 2003
  9. JIS T 4207 Infrared ear thermometers, 2005
  10. I. Pusnik, "Development of the ISO standard for clinical thermometers", IFMBE Proceedings 16, pp. 401-404, 2007
  11. KS P6002 Clinical electrical thermometers with maximum device, 1992 (Reapproved 2004)
  12. 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
  13. 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.
  14. 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.
  15. 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. https://doi.org/10.1097/00003246-199308000-00018
  16. 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.