高分子耗材可沥滤物的安全性评价
Safety Evaluation of the Leachable Substances of High Polymer Material Products
-
摘要: 结合高分子材料特性及与人体接触的特点,从风险控制的角度,探讨高分子耗材中可沥滤物安全性评价的必要性、总体评价策略、具体研究思路及方法,供国内该类器械的研发及上市前评价者参考。Abstract: Combined with the characteristics of polymer material properties and contact with the human body, this paper investigates safety evaluation necessary, general evaluation strategies, specific research ideas and methods of leachable substances in polymer material products in order to provide reference for the researcher and reviewer of this kind of products from the point of risk control.