• Journal of Acupuncture Research
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• v.20 no.5
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• pp.151-158
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• 2003

Objective: There have not been so many study about the quality of acupuncture needle tip. In order to ensure safe acupuncture treatment, the quality of needle tip is essential. Therefore we investigated the current condition of the tip of the acupuncture needles in Korea. Methods: We have selected the needles that made by 8 companies in Korea, and selected 50 pieces from 1000 pieces each company by randomized methods. and observed the tip of each needle using a scanning electron microscope at ${\times}800$ magnification. Results & 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. There was much difference on the quality of needle among the manufacturer, and some needles seem to need to do- thorough quality control. It is necessary to intensify quality management and a concentrated control on manufacturing process of 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.

• The Journal of Korean Medicine
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• v.23 no.4
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• pp.27-31
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• 2002

Background and Purpose: There has been little study about the quality of acupuncture needle tips. In order to ensure safe acupuncture treatment, high quality of needle tips is essential. Therefore, we investigated the current condition of the tips of the acupuncture needles on the market. Methods: We selected needles made by 6 companies in Korea, one company each in Japan, the USA and China, and observed the tip of each needle using a scanning electron microscope. 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, and peeled off coated tips. There were more faulty ones than good ones. Further, better-designed study with a bigger sample size is warranted.

• Journal of Acupuncture Research
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• v.22 no.5
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• pp.49-55
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• 2005

Objectives : In order to ensure safe Herbal Acupuncture treatment, the quality of needle tip is much important. Therefore we investigated micromorphological characteristics of Herbal Acupuncture needle tip according to the number of injection. Methods : We have selected the 26 Gage syringes & 29 Gage syringes that using currently in Herbal Acupuncture treatment. And we evaluated the change of shape of Herbal Acupuncture needle tip after several times of injection by Inverted System Microscope(x 200). Results & Conclusion : We found at Herbal Acupuncture needle tips had several defects such as hooked, scuffed, lump and irregular, stubbed or malformed shape in spite of new syringes. And we found at Herbal Acupuncture needle tips had several defects that is harmful to body such as mild pain, possibility of damage of tissue after several times of injection. Therefore it is necessary to pay attention to use Herbal Acupuncture needle tips.

• Journal of Acupuncture Research
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• v.22 no.6
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• pp.135-140
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• 2005

Objectives : There have been several studies about the quality of acupuncture needle tip recently. We have investigated the condition of the tip of the acupuncture needles in the last studies. In the former studies, we discovered the metallic scuff, lumps and irregularities of the acupuncture needle tips under the microscope. But, no information was available on those foreign materials' identity. Methods : We have selected 200 needles of 1000 pieces from several companies by randomized methods. And we observed the tip of the 6 needles selected finally at ${\times}1000\;or\;{\times}3000$ magnification and analyzed the components of the metallic scuff, lumps and irregularities of the needle tips with a SEM-EDX analyser. Results : We found that the identity of the metallic scuff, lumps and irregularities of the needle tips were metallic materials and silicon. For example, A point was composed of Fe(69.78%), Cr(17.71%), Ni(8.11%), Zn(2.04%), Si(1.23%), Mn(1.12%), and B point was composed of Si(66.40%), Fe(26.76%), Cr(6.84%). Conclusion : The results of this study confirm that there is a real possibility of the remaining of metallic materials and silicon in body of patient, after acupuncture treatment. Therefore, it is necessary to intensify our efforts to make needles of good quality and to concentrate on manufacturing process of acupuncture needles completely to be free from danger in acupuncture treatment.

• 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.

• Korean Journal of Oriental Medicine
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• v.16 no.3
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• pp.115-121
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• 2010

Objectives : Quality control of the needle tips and prevention of pollutions are important factor for safe and effective acupuncture treatment. Ear acupuncture needle is made by 3 companies in Korea, and used to treat for obesity or smoking in clinic frequently, but the Korean industrial Standard is proposed most recently. In spite of the importance, there has been little study about that. Moreover, there was no study about ear acupuncture needle. Methods : We investigated the current condition of needle shape and pollution about the tips and body of the ear acupuncture needle under the stereoscopic microscope. Samples are selected 100 pieces from 300 pieces randomly in each company. Results : The substandard needles are classified into four groups and counted 1. Normal condition (55.3%), 2. Scratch on the surface (14.0%), 3. Malformation of tips (19.3%), 4. Pollution of body (4.3%), 5. Multiple Substandard (7.0%). In the case of including type 2 as a standard needle, normal rate of A company was 81% when B was 76%, and C was 51%. Conclusion : The substandard ear acupuncture needles can induce local side effects such as needling pain or itching. Furthermore, it can disturb the proper effect of acupuncture treatment. We hope that this study can help to improvequality of ear acupuncture and reduce substandard rate for safe and effective ear acupuncture treatment.

• 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.

• Proceedings of the Korean Society for Technology of Plasticity Conference
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• 2004.05a
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• pp.250-253
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• 2004

Sharpness of the tip of micro needle is very Important quality that should be controlled in the manufacturing processes. Acupuncture needle is one of the most widely used micro-needle. And the tip sharpness of acupuncture needle Is usually checked by the magnitude of resisting force obtained through sharpness test. In this study, some sharpness tests of acupuncture needle were done and the relationship between the misalignment of specimen and the magnitude of resisting force. The diameter of the needle used in the test was $250\;{\mu}m$ and the length of it was 40 mm.

• Journal of Acupuncture Research
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• v.28 no.5
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• pp.97-102
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• 2011

Meridian Research Center, Division of Standard Research, Keora Institute of Oriental Medicine Objectives : Ear acupuncture needle is used to treat smoking, drug abusing, alcoholism frequently over time stability of ear acupuncture needle is important factor for safe acupuncture treatment. In spite of the importance, there has been few study about the quality of disposable acupuncture needle tip - using scanning electron microscope (SEM) in 2002, 2003. Moreover, there was no study about ear acupuncture needle. Methods : The three ear acupuncture needle, made in China, Japan, Korea was chosen. We used Hank's solution at the 38$^{\circ}C$ as a phantom tissue liquid. Except for the control group, five groups of needles are soused one to five days. Surface corrosion was observed using the SEM compared with control group. Results : There was no particular corrosion in all groups of ear acupuncture needles compared with the control group. Conclusions : All of the ear acupunctures used in this study are stable in body fluids at least 5 days.