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KMID : 0363620060270030222
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Journal of Korean Oriental Medicine
2006 Volume.27 No. 3 p.222 ~ p.226
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Perspective on the Development of the Cooperation Group Standards of Acupuncture Needles for Single Use in Korea
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Jang In-Soo
Koo Sung-Tae
Kim Jang-Hyun
Park Jae-Hyun
Park jong-Bae
Park Hi-Joon
Seo Jung-Chul
Song Ho-Sueb
Lee In-Hwan
Lee Hyang-Sook
Choi Sun-Mi
Han Chang-Ho
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Abstract
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Objective: The aim of this study was to introduce newly developed cooperation group standards of acupuncture needles for single use and to make a contribution to the future development of Korean Industrial Standards (KS) of acupuncture needles for single use.
Results and Conclusion: Quality assurance and quality control with high safety profile is one of the most critical issues in medical device manufacturing. Up to now, proper attention has not been paid to this issue with respect to acupuncture needles for single use and their related devices. We, therefore, organized a committee to make guidelines to produce an acupuncture needle with high quality and safety. In the committee, we reviewed the topic from an historical viewpoint, and investigated the current situation of the standardization of acupuncture needles in other developed countries. Finally, we developed the cooperation group standards in advance of development of KS on the acupuncture needles for single use. The standards are composed of 12 sections describing: Scope, Normative references, Definitions, Materials, Configuration, Appearance and Cleanliness, Quality, Sterilization and Safety, Processing of Surface and Coating Material, Test, Packaging, and Labeling. We hope that the standards would be useful guidelines to produce high quality acupuncture needles and play an important role in the development of KS in the future.
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KEYWORD
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Acupuncture needles, cooperation group standards, Korean Industrial Standards (KS), quality of acupuncture, safety
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