Identification and quantification of degradation products according to ISO 10993-9

Materials used in the manufacture of medical devices can generate degradation products when exposed to their biological environment. In this context, it is important to ensure their level of tolerability for the safety of certain medical devices, by conducting investigations to identify and quantify them.

The ISO 10993-9 standard brings together the different general principles for the evaluation and design of degradation studies of materials used in Medical Devices – “degradation” meaning here “decomposition of the material”. It deals only with degradation products resulting from chemical alteration of the device in the human body, not from mechanical stress or wear. Also, it is important to note that this standard does not refer to the extractable and leachable compounds studied in Part 18 of ISO 10993. 

The method of assessing degradation will vary depending on the nature of the material being studied, the medical device and its anatomical location.