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  • P-ISSN 1010-0695
  • E-ISSN 2288-3339

Perspective on the development of the cooperation group standardsof acupuncture needles for single use in Korea

Journal of Korean Medicine / Journal of Korean Medicine, (P)1010-0695; (E)2288-3339
2006, v.27 no.3, pp.231-235












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Abstract

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 development of Korea Industrial Standards (KS) of acupuncture needles for single use in the future. 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 its 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 view point, 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 Labelling. 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.

keywords
Acupuncture needles, Cooperation group standards, Korean Industrial Standards (KS), Quality of acupuncture, Safety, Acupuncture needles, Cooperation group standards, Korean Industrial Standards (KS), Quality of acupuncture, Safety


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