ANSI/AAMI/ISO 10993-9提供了系统评估医疗器械潜在和观察到的生物降解以及生物降解研究的设计和性能的一般原则。从这些研究中获得的信息可用于ISO 10993系列中描述的生物学评估。考虑不可再吸收和可再吸收材料。不适用于:a）纯机械过程引起的降解评估；具体产品标准（如适用）中描述了此类降解产品的生产方法； b） 非降解产物的可浸出成分；c） 不直接或间接接触患者身体的医疗设备或部件。

ANSI/AAMI/ISO 10993-9 provides general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and performance of biodegradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series. Considers both non-resorbable and resorbable materials. Not applicable to: a) evaluation of degradation which occurs by purely mechanical processes; methodologies for the production of this type of degradation product are described in specific product standards, where available; b) leachable components which are not degradation products; c) medical devices or components that do not contact the patient's body directly or indirectly.