• Journal of the Institute of Electronics and Information Engineers
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• v.50 no.3
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• pp.187-202
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• 2013

The electronic medical device industry and the relevant market have been greatly expanded owing to various factors, such as the advent of the aged society and the spread of the desire for well-being in developed countries, and rapid development of China, India and other emerging markets. The electrical stimulator is one of electronic medical devices most commonly used in homes. The electrical stimulator is widely used for pain relief, rehabilitation, muscle conditioning and others. Since it is mainly used in homes, it is very important to assure the safety and performance for protection of users. However, there is no guideline on evaluation of safety and performance of such electrical stimulator for home use. In this study, various local and foreign references were reviewed to develop the internationally harmonized procedures for safety and performance evaluation of the electrical stimulator and test items, specifications and methods are proposed. In addition, such proposed test items were validated to decide the internationally harmonized tests for safety and performance evaluation. This study will contribute to improvement of quality and safety of electrical stimulators for home use and help the Korean medical device industry have the international competitiveness.