纳米结构医疗器械:监管视角和当前应用
Giuseppe D'Avenio1, Carla Daniele1, Mauro Grigioni1
1National Centre for Innovative Technologies in Public Health, Italian National Institute of Health (ISS), 00161 Rome, Italy.
Materials (Basel, Switzerland)
|April 27, 2024
概括
纳米材料 (NM) 越来越多地用于医疗器械 (MD),但它们的安全性需要仔细评估. 本研究回顾了医疗药师的NM应用,并讨论了确保患者安全的监管挑战.
科学领域:
- 材料科学 材料科学 材料科学
- 生物医学工程 生物医学工程
- 监管科学 监管科学
背景情况:
- 纳米材料 (NM) 是现代医疗器械 (MD) 制造的组成部分.
- NMs的独特特性提供了显著的优势,但也带来了潜在的风险.
- 由于潜在的准确性问题,已建立的安全评估方法可能需要对NMS进行调整.
研究的目的:
- 探索NMS在医疗器械中的当前应用.
- 检查MD中NMs的监管格局,特别是欧洲法规2017/745.
- 要突出与含有NM的MD相关的安全考虑和挑战.
主要方法:
- 关于目前在医疗药师中使用 NM 的文献综述.
- 分析监管文件,重点关注欧洲法规2017/745 (规则19条).
- 讨论评估NM生物效应的方法挑战,例如细胞毒性.
主要成果:
- 纳米结构的MDs在各种医学领域普遍存在.
- 欧洲法规2017/745将MD与NM分类为III类,除非暴露是可以忽略不计的.
- 标准毒理学测定可能会受到NM存在的影响,需要方法验证.
结论:
- 在进入市场之前,严格的安全评估对含有NM的MDs至关重要.
- 监管框架正在不断发展,以应对医疗应用中NMS的特定风险.
- 对验证的测试方法进行进一步的研究对于NM安全性至关重要.
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