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低温蒸发过氧化对3D打印设备的灭菌
Randal Eveland1, Kathleen Antloga2, Ashley Meyer2
1STERIS, 5960 Heisley Road, Mentor, OH, 44060, USA. randal_eveland@steris.com.
3D printing in medicine
|February 28, 2024
概括
蒸发过氧化灭菌可以有效地灭菌3D打印的医疗设备. 研究证实了低温灭菌周期后的生物相容性和材料完整性.
科学领域:
- 生物医学工程 生物医学工程
- 材料科学 材料科学 材料科学
- 消毒技术 消毒技术
背景情况:
- 低温蒸发过氧化 (VH2O2) 灭菌是一种可重复使用的医疗器械的标准医院方法.
- 该研究调查了3D打印材料的VH2O2杀菌,评估了关键的安全性和性能参数.
研究的目的:
- 为了评估3D打印医疗设备的VH2O2杀菌的有效性.
- 评估3D打印材料在杀菌后的生物兼容性和材料兼容性.
主要方法:
- 3D打印材料 (BioMed ClearTM,BioMed AmberTM,MED610TM,MED615TM,MED620TM) 在V-PROTM杀菌器中使用VH2O2进行了杀菌.
- 绝育疗效通过过度杀死方法 (1⁄2 周期) 确定. 评估了生物相容性和材料相容性 (ASTM方法,维度分析).
主要成果:
- 在VH2O2 1⁄2周期后,3D打印设备在指定设计参数内实现了无菌性.
- 灭菌后,材料没有表现出细胞毒性,敏感性,刺激性,全身毒性或 pyrogenicity,并且是血液相容的.
- 在VH2O2灭菌后,材料强度和尺寸稳定性基本保持不变.
结论:
- 低温VH2O2杀菌是一种适合3D打印医疗器械的方法.
- 这些发现支持对使用特定材料,打印机和设计的3D打印设备的灭菌的监管提交.
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