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KMID : 1142220160110020219
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Regulatory Research on Food, Drug & Cosmetic
2016 Volume.11 No. 2 p.219 ~ p.228
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A Study on the Development of Performance Method Guideline for an Injectable Nucleus Pulposus Implant
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You Ji-Hye
Lee Hui-Sung
Yoo Si-Hyung
Lee Chang-Hyung
Kim Eun-Kyo
Kim Sun-Young
Lee Se-Eun
Park Chang-Won
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Abstract
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Pedicle screws, cages and plates are typically used for general lumbar spine disc diseases. However, it has been revealed that they have a number of defects and therefore nucleus pulposus implant, which can maintain permanent hydration condition and pressure by absorbing fluids of the human body to overcome such defects, is emerging as their replacement. However, as there have been fewer methods to evaluate nucleus pulposus implant. This study is technical development trends for forms and materials of nucleus pulposus implant not only in Korea but also in foreign countries such as the United States and Europe were analyzed. In addition, document reviews of relevant standards including ISO documents and related literature along with investigation and analysis of testing items and methods which are nationally and internationally recognized were performed to draw testing items and methods to evaluate the physical and mechanical characteristics. The items and methods were also verified by testing. As a result of this study might support the product development.
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KEYWORD
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nucleus pulposus, implant, evaluation, guideline
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