ISO10993.1给出了生物相容性、生物学风险和生物学安全性标准定义：
1、生物相容性 biocompatibility
ability of a medical device or material to perform with an appropriate host response in a specific application
某一医疗器械或材料在特定应用中具有适宜宿主反应的能力
2、生物学风险 biological risk
combination of the probability of harm to health occurring as a result of adverse reactions associated with medical device or material interactions, and the severity of that harm
医疗器械或材料与人体间相互作用引起的健康危害发生的概率和危害的严重程度的结合
3、生物学安全性 biological safetyfreedom from unacceptable biological risk in the context of the intended use
在预期使用中无不可接受的生物学风险
参考文献：ISO10993.1-2018