Abstract Effective sterilization methods for single-use devices are a growing need for the medical industry. Concerns with safety, throughput and source availability, however, prompt prudent contingency planning for gamma irradiation of devices suited for radiation sterilization. Electron beam (e-beam) and X-ray represent two alternatives to gamma radiation if they can be confirmed to be compatible with sterilization of the devices. To address this question, the effects of sterilization-relevant doses of e-beam and X-ray radiation are directly compared to the effects of gamma radiation using two prototypical commercial devices currently sterilized using cobalt-60 gamma radiation. These devices include components that comprise six distinct polymer materials commonly used in the medical device industry. The devices investigated are the Becton, Dickinson and Company (BD) VacutainerTM Plus tube, comprised of low-density polyethylene, chlorobutyl rubber, and polyethylene terephthalate components; and the BD VacutainerTM Push Button Blood Collection Set, containing polypropylene, polyolefin elastomer, and polyvinyl chloride components. Changes in functionality, discoloration and select mechanical properties of components of each device were measured following exposure to targeted doses of 15, 35, 50 and 80 kGy. A statistical analysis was performed to determine if the effects of e-beam or X-ray radiation differ from the effects of gamma radiation for the properties considered. No devices were found to fail the functional performance tests at any of the doses considered. Small, but statistically significant differences were observed in device discoloration from e-beam, X-ray and gamma radiation following processing for certain materials at certain dose levels. Both e-beam and X-ray irradiation appear as viable alternatives to gamma irradiation for sterilization of the medical devices and materials considered.

中文翻译：

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伽玛、电子束和 X 射线辐照对一次性塑料部件采血装置的直接比较

摘要 医疗行业对一次性器械的有效灭菌方法日益增长的需求。然而，对安全性、吞吐量和源可用性的关注，促使对适用于辐射灭菌的设备的伽马辐照进行谨慎的应急计划。如果可以确认电子束（e-beam）和 X 射线与设备的灭菌兼容，则它们是伽马辐射的两种替代方案。为了解决这个问题，将电子束和 X 射线辐射的灭菌相关剂量的影响与使用目前使用钴 60 伽马辐射灭菌的两种原型商业设备的伽马辐射的影响进行了直接比较。这些设备包括包含六种不同聚合物材料的组件，这些聚合物材料通常用于医疗设备行业。研究的设备是 Becton，Dickinson and Company (BD) VacutainerTM Plus 管，由低密度聚乙烯、氯化丁基橡胶和聚对苯二甲酸乙二醇酯组成；和 BD VacutainerTM 按钮式采血套装，包含聚丙烯、聚烯烃弹性体和聚氯乙烯成分。在暴露于 15、35、50 和 80 kGy 的目标剂量后，测量了每个设备组件的功能、变色和选定机械性能的变化。进行了统计分析以确定电子束或 X 射线辐射的影响是否与伽马辐射的影响不同。没有发现任何设备在任何考虑的剂量下都无法通过功能性能测试。在电子束引起的器件变色方面观察到微小但具有统计学意义的差异，在某些剂量水平下对某些材料进行加工后的 X 射线和伽马辐射。电子束和 X 射线辐照似乎是伽马辐照的可行替代方案，用于对所考虑的医疗设备和材料进行灭菌。