CleanControlling: Toxicological evaluation | DIN EN ISO 10993-17

Toxicological evaluation according to DIN EN ISO 10993-17

Toxicological risk assessment of medical device components

Within the framework of the biological assessment, the data obtained with the chemical characterization according to DIN EN ISO 10993-18 are to be evaluated qualitatively and quantitatively. The basis for the toxicological risk assessment of these findings is DIN EN ISO 10993-17.

The evaluation includes, among other things, the data from the extractables and leachables, the intended use (duration of use, age group, frequency of use, etc.) and researched limit values.

Valuation bases	Data acquisition
Analysis results Extractables	Chemische Charakterisierung nach DIN EN ISO 10993-18, Extraktion nach DIN EN ISO 10993-12
Intended use (duration of use, age group, repeated use, route of exposure)	Manufacturer information, product classification
Researched limit values	Database search

Further information

This service does not fall within the scope of accreditation and also not the acceptance on behalf of ZLG and GLP of CleanControlling Medical GmbH & Co. KG.
You can also find detailed information on test procedures and test standards in our Infothek
If you have any questions, the employees from our sales team will be happy to help you.