• The Journal of Korean Medicine
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• v.26 no.2 s.62
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• pp.166-175
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• 2005

Objecitve: To present criteria for acupuncture standardization, which will improve the quality of acupuncture and secure safety, through studies of the biocompatibility of acupuncture needles. Methods: Acupuncture needles distributed in Korea were studied. Acute poisonous tests and pyrogenicity materials tests were executed to study the biocompatibility of acupuncture needles. Results & Conclusions: All 3 brands of acupuncture needles commonly distributed in Korea were found suitable for medical use, through acute poisonous tests and pyrogenicity materials tests. However, the medical instrument standards of the Korea Food and Drug Administration for acupuncture lack criteria concerning acute poisonous tests and pyrogenicity materials tests. The criteria for these tests should be standardized in order to secure the biocompatibility of acupuncture needles.