• The Journal of Korean Medicine
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• v.27 no.3 s.67
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• pp.222-226
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• 2006

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.

• Journal of Pharmacopuncture
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• v.25 no.4
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• pp.382-389
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• 2022

Objectives: The Korean Industrial Standard (KS) for sterile acupuncture needles was established in 2009 based on research on the quality control of acupuncture needles. We aimed to determine the quality of acupuncture needles available in South Korea in 2021 by examining their surface condition and chemical composition using field-emission scanning electron microscopy (FE-SEM) and energy-dispersive X-ray spectroscopy (EDS). Methods: In South Korea, there are 23 brands of acupuncture needles, and we examined 10-15 needles from each brand, resulting in a total of 285 needles. The microstructures of the needles were assessed by SEM. Using SEM images, we evaluated the acupuncture needle tips for the following defects/aspects: scratches, lumps, detached coating, bent tip, and tip sharpness. EDS was used to determine the chemical composition of the selected acupuncture needles. Results: Overall, 88.4% of 285 needles were found to have at least one type of abnormality. The most frequently observed abnormalities were scratches and dents on the surface (68.1%), followed by detached coating (63.2%), and lumps (61.8%); blunt tips were observed in about 24% of them. Of 252 needles with at least one defect, 86.9% had two or more types of defects. The ratio of the number of needles with any defect to that of needles without any defect varied among brands, ranging from 50% to 100%. Regarding foreign materials, higher proportions of Si and O were observed on the needles, indicating incomplete or detached silicone coating. Conclusion: The quality of acupuncture needles varied among brands, suggesting that further improvements can be made through various inspection methods.

• Korean Journal of Acupuncture
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• v.35 no.2
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• pp.47-55
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• 2018

Objectives: Clinical improvements can be observed following placebo administrations in clinical trials. Randomized controlled trials have been conducted to disentangle the specific effects of therapeutic interventions over the past decade. In acupuncture trials, non-penetrating placebo needles offer the opportunity to determine the specific effects of needling. Methods: The present review provides an overview of the concept of the placebo effect and the characteristics of the placebo needles. Results: Placebo control can contribute to minimize for bias and the contextual and psychological components of therapeutic interventions. Placebo control should meet two criteria: blinding efficacy (indistinguishable from active treatment) and physiological inertness. In the case of acupuncture, however, it is difficult to meet both criteria simultaneously. The dilemma of placebo needles suggests that placebo needles do not constitute proper control in acupuncture research. Considering the characteristics of placebo needles, patients are more likely to perceive placebo needles as active treatment in acupuncture trials compared to placebo pills in pharmaceutical trials. Placebo response might be observed more frequently to placebo needles than to placebo pills. When acupuncture treatments are utilized in clinical use, placebo effects can be enhanced by exploiting patients' expectations in the contextual or environmental cues that surround medical intervention. Conclusions: We have to consider these unique characteristics of placebo needles in order to avoid drawing premature conclusions that acupuncture itself is just a placebo.

• International journal of advanced smart convergence
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• v.9 no.4
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• pp.62-73
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• 2020

In this paper, we present electronic acupuncture needles we have developed using intelligence technology based on Bluetooth in order to allow anyone to simply receive customized remote diagnosis and treatment by clicking on the menu of the smartphone regardless of time and place. In order to determine the health condition and disease of patients, we have developed a software and a hardware of electronic acupuncture needles, operating on Bluetooth which transmits biometric data to oriental medical doctors using the functions of automatically determining pulse diagnosis, tongue diagnosis, and oxygen saturation; the functions are most commonly used in herbal treatment. In addition, using fuzzy logic and reasoning based on smartphones, we present in this paper an algorithm and the results of completion of hardware implementation for electronic acupuncture needles, appropriate for the body conditions of patients; the algorithm and the hardware implementation are for a treatment time duration by electronic acupuncture needles, an automatic determinations of pulse diagnosis, tongue diagnosis, and oxygen saturation, a function implementation for automatic display of acupuncture point, and a strength adjustment of electronic acupuncture needles. As a result of our simulation, we have shown that the treatment of patients, performed using an Electronic Acupuncture Needles based on intelligence, is more efficient compared to the treatment that was performed before.

• 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.

• Journal of Acupuncture Research
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• v.31 no.2
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• pp.21-30
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• 2014

Objectives : Manufacturing and manipulation techniques of acupuncture can be interpreted as an induced electromagnetic viewpoint, as proposed in previous study. Considering from this point of view, the magnetization of needles should be essential to enhance the electromagnetic effects during the behavior of the acupuncture needling. Methods : The current disposable needles are made of non-magnetic stainless steels, so ferromagnetic materials were searched as suitable substitutes. Meanwhile, at the practical view, stainless steels are very available for the several superior properties like as corrosion resistance, strength, etc., magnetic stainless steels were first investigated. Some types of them still preserved the ferromagnetic properties of iron, so trial needles were made with them. And then magnetization of them were followed. Results : Among the hundreds types of stainless steels, martensitic or ferritic ones are ferromagnetic. The needles made with these ferromagnetic wires were magnetized, and polarized by magnetizer, and their magnetic properties were improved. Moreover, in addition to the superiority of the magnetism, the electrical and thermal conductivities of them were even better than those of the current austenitic stainless steels. Conclusions : Through the developmental study based on the electromagnetic viewpoint, the magnetized and polarized acupuncture needles were completed. This means that these needles having improved magnetism can be used to improve the electromagnetic needling effects, and moreover, their superiorities in the electrical and thermal conductivities can also give another benefits in treatments of electrical or warm needling.

• Journal of Pharmacopuncture
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• v.8 no.1
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• pp.67-71
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• 2005

Objectives : This study was conducted to observe the tip of needles which induce poor needle sensation upon injection of herbal acupuncture. Methods : Among the syringes used for herbal acupuncture, needles which cause poor sensation were collected and evaluated by SEM (scanning electron microscope) for changes in structure, existence of impure matters, physical damage, and etc. Results : 1. Various forms contributed to poor needle sensation. Bent needle body, damaged or crooked needle tip, and blunted tip 2. Poor needles could be made during the manufacturing process, during insertion of the needle into the vial(except for the lubricants), and repeated procedures with one needle at different regions. Conclusion : Poor needles induce unnecessary pain and discomfort not only to the patients but also to administrators during injection. Herbal acupuncture is a treatment technique injecting herbal extract on the meridian points, and strict quality check must be enforced to prevent occurrence of poor needles.

• Journal of Acupuncture Research
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• v.30 no.5
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• pp.95-105
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• 2013

Objectives : The purpose of this study is to examine the preparing methods of the traditional acupuncture needle and to interpret the electromagnetic meaning intervened in them. Methods : The overall manufacturing processes of the acupuncture needles in ancient books were surveyed. And the facts that special functional activities were carried out in common in the preparing processes were detected. The reproduction tests for the detected former functional activities were followed. Results : According to the ancient medical books, the traditional acupuncture needles were treated with the magnet through the preparing processes. The reproduction tests provided the fact that the ferromagnetic iron needles treated with the magnet were enhanced their magnetisms. And major techniques of the ancient supplementation and draining can be interpreted as magnetic or induced electromagnetic actions. Conclusions : Considering the electromagnetic characteristics of human body, the magnet treated ferromagnetic iron needles of ancient era and magnetic or induced electromagnetic interpretable manipulation techniques are the historical evidences of magnetic activities of acupuncture. So modern acupuncture therapy should be understood, studied, and reinterpreted as an electromagnetic viewpoint.

• Journal of Acupuncture Research
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• v.21 no.5
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• pp.149-162
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• 2004

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.

• Korean Journal of Acupuncture
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• v.21 no.4
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• pp.43-51
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• 2004

Objectives : In order to ensure safe acupuncture treatment, the quality of the needle tip is essential. But, there have not been so many studies about the quality of the acupuncture needle tip. For this reason we have been already reported about the quality of acupuncture needle tip in Korea using scanning electron microscope(SEM) in 2002, 2003. In order to compare than other society, we investigated the current condition of the tips of the acupuncture needles sold in Europe. Methods : We obtained the needles made by 7 companies, which are sold currently in Europe, and selected 50 pieces out of 100 pieces from each company by randomized methods. And then we observed the tip of each needle using a scanning electron microscope at ${\times}800$ magnification. Results and Discussion : We found that needles had several defects such as scratch marks on the surface, metallic scuff, lumps and irregularities of the needle tips, stubbed or malformed tips, tips of point off-center, peeled off coated tips, same as Korean needles. There was much difference on the quality of needles among the manufacturers, and some needles seem to need thorough quality control. Allowing for the high price, the quality of some needle in Europe generally are better than that of Korean needles. But some Korean needles hold a top position than European ones in quality. We want a good industrial standard to be made in acupuncture manufacturing fields in the near future, because the safety is not less valuable than the efficacy in medicine.