GLP法规下医疗器械生物学试验的实施要点

Points to Consider on Biological Tests of Medical Devices under GLP Regulation

目的论述GLP法规下医疗器械生物学试验的实施要点。为我国推行医疗器械GLP以及为从事医疗器械检测检验的实验人员提供参考。方法介绍医疗器械生物学试验的特点、生物学评价的原则及生物学试验的实施要点。结果与结论医疗器械生物学试验应根据其材料和用途等特征选择合适的试验方法,依据风险评价、风险-利益分析、GLP及重新评价等原则进行安全性评价。

Objective The important points to perform the biological evaluation of medical devices under GLP are discussed.To promote the medical device GLP to be carried out and provide reference for the medical device evaluation personnel. Methods Introducing the characters of biological test,principle of biological evaluation as well as important points to perform biological evaluation. Results and Conclusion Medical device should be evaluated by suitable biological test according to the character of material and use under a series of principles,such as risk analysis,risk-benefit analysis,GLP and re-evaluation.