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A Case for Specifying Materials The Perspective of an FDA Engineer

机译:用于指定材料的案例FDA工程师的角度

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In recent years, the use of ceramics as biomedical materials has been given greater publicity. Even so, the development of ceramics for biomedical applications and their delivery to final prouduct has been slow. Even though people are living longer and the United States is a major market for medical devices, Europe, as noted by Mecholsky has put together a much more integrative effort toward the development of biomaterials (and thus "bio" ceramics) than has the U.S. His points ought be taken carefully, the change in demographics and the advancement of technology are requiring that more medical devices be placed into a larger number of people. Because of both technological advances and the market reality, the future of devices is that they will be implanted into an increasing number of people. As technology advances, devices will be implanted into patients that presentwith less compromising symptoms, they will be implanted into younger and younger patients and those devices will tend to work better. Thus we are seeing a need for materials that will be placed into devices that will enhance the longevity and/or performance of each device.
机译:近年来,陶瓷用作生物医学材料的使用已更大宣传。即便如此,生物医学应用的陶瓷的发展及其向最终产品的交付已经缓慢。尽管人们的生活更长,但美国是欧洲的主要市场,欧洲,如Mecholsky所指出的那样,Mecholsky所指出的更加综合的努力发展生物材料(因此“生物”陶瓷)而不是美国他的要仔细考虑积分,人口统计数据的变化和技术进步要求将更多的医疗设备放入更多的人中。由于技术进步和市场现实,设备的未来是他们将植入越来越多的人。随着技术的进步,将植入患者植入症状的患者,它们将被植入年轻人和年轻的患者,并且这些设备往往会更好地工作。因此,我们看到需要将其放入到能够增强每个设备的寿命和/或性能的设备中的材料。

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