ISO 10993 Medical Devices

The main objective of ISO 10993 is to protect humans from possible biological risks of using medical devices.

ISO 10993 is aimed at determining the general effects of medical devices in tissues rather than specifying a particular device.

Therefore, for a complete evaluation of biological safety, we must classify devices according to the nature and duration of contact with human tissue when in use and indicate so in the matrices. Biological data are classified as surface, implant or external device.

Depending on the exposure time and form of contact of tests the following can be performed: cytotoxicity, sensitization, irritation or intradermal skin, systemic toxicity, chronic toxicity, genotoxicity, bone or muscle implantation and hemo-compatibility