침의 한국산업규격(KS) 도입 필요성에 대한 고찰

Need for Korean Industrial Standards (KS) for Acupuncture Needle

Quality assurance with high safety profile is one of the most critical issues to medical device manufacturing. In general, this issue was not paid proper attention with respect to acupuncture needle and its related devices. Acupuncture needles are manufactured through various standards ranging from purely hand-made, partially hand-made and partially machine-made, to fully machine-made mainly in China, Korea, and Japan. There is a large difference in quality between needles from different manufacturers. In order to provide a standard manufacturing guideline, it seems necessary to make a Korean Industrial standard (KS). The authors review this topic from an historical view point, investigate the current situation of the standardization of acupuncture needles in other developed countries, and inspect the general procedure to establish a KS in Korea in order to suggest a KS for acupuncture needles.