医疗器械生物学评价新进展

Current Progress on Biological Evaluation for Medical Devices

通过对医疗器械生物学评价的国内外新进展进行介绍,重点解读ISO 10993-1:2018新标准内容中全生命周期生物学评价、毒理学风险评估、评价终点和包装材料的生物学评价考虑等核心理念的变化要点以及如何科学、合理地使用该标准,旨在帮助大家了解医疗器械生物学评价的国内外发展方向,为更好地开展医疗器械生物学评价服务。

To broadly understand the new direction of biological evaluation for medical devices,we introduced both domestic and international progress of biological evaluation and focused on illustrating the key points on full life-cycle biological evaluation,toxicological risk evaluation,evaluation endpoints and package material evaluation concern as well as how to use the update vision of ISO 10993-1:2018 scientifically and reasonably in order to provide us better services on performing biological evaluation for medical devices.