Objectives : To present criteria for acupuncture standardization, which will improve quality of acupuncture and secure safety, through studies of the biocompatibility of acupuncture materials. Methods : Acupuncture needles distributed in Korea were studied. Intracutaneous reaction tests and sterility tests were executed to study the biocompatibility of acupuncture. Results & Conclusions : All 4 kinds of acupuncture needles distributed in Korea were found suitable for medical use, through intracutaneous reaction tests and sterility tests. However, the medical instrument standards of the Korea Food and Drug Administration lack criteria concerning intracutaneous reaction tests and sterility tests. The criteria for these tests should be standardized in order to secure the biocompatibility of acupuncture needles.