The medical device industry has been investigating ways to increase the use of alternatives to cobalt-60 gamma radiation and ethylene-oxide gas sterilization, such as electron beam (E-beam) and X-ray radiation, due to regulatory and market pressures. One impediment to switching to E-beam or X-ray technology for sterilization is the lack of data on the effects of these radiation sources on medical device polymers. To provide such data this work considers irradiation and testing of a common single-use medical bone cement mixing system, the Stryker Advanced Cement Mixer (ACM®), that is composed of seven polymer materials. The ACM® devices considered here were processed to sterilization-relevant doses (15, 25, 50, and 70 kGy) using three radiation technologies: gamma, E-beam, and X-ray. The system and its polymer components were tested for product functionality, as well as mechanical and visual properties to determine how exposure effects may be influenced by radiation technology and dose level. We found that although there were instances of statistically significant differences in effects between the gamma-irradiated products and those irradiated with E-beam and X-ray, those effects were negligible in terms of retained functionality of the product and retained mechanical properties of the polymer components. Overall, results of this study demonstrate that, for of the effects studied, E-beam and X-ray are viable alternatives to cobalt-60 gamma radiation for sterilization of the polymer-based device investigated.

中文翻译：

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先进的骨水泥混合器装置中伽马、电子束和 X 射线辐照对聚合物的影响


由于监管和市场压力，医疗器械行业一直在研究增加使用钴-60 γ 射线和环氧乙烷气体灭菌替代品的方法，例如电子束 （E-beam） 和 X 射线辐射。改用电子束或 X 射线技术进行灭菌的一个障碍是缺乏关于这些辐射源对医疗器械聚合物影响的数据。为了提供此类数据，这项工作考虑了一种常见的一次性医用骨水泥混合系统的照射和测试，即 Stryker 高级水泥搅拌机 （ACM®），该系统由七种聚合物材料组成。这里考虑的 ACM® 设备使用三种辐射技术处理成灭菌相关剂量（15、25、50 和 70 kGy）：γ、E 射线和 X 射线。该系统及其聚合物组件经过产品功能以及机械和视觉特性测试，以确定辐射技术和剂量水平如何影响暴露效应。我们发现，尽管 γ 射线辐照产品与用 E 束和 X 射线辐照的产品之间存在统计学上显着的影响差异，但就产品的保留功能和聚合物成分的保留机械性能而言，这些影响可以忽略不计。总体而言，这项研究的结果表明，就所研究的效果而言，电子束和 X 射线是钴-60 γ 辐射的可行替代品，用于对所研究的聚合物基设备进行灭菌。