Identifying and quantifying the chemicals a device may release — the factual foundation every toxicological risk assessment depends on.
Chemical Characterization is the systematic identification and quantification of chemical constituents present in or released from a medical device or its materials. Following ISO 10993-18, this includes extractables studies under exaggerated conditions to identify the full profile of potential chemicals, and leachables studies under clinically relevant conditions to identify what a patient would actually be exposed to.
The resulting chemical data feeds directly into the toxicological risk assessment and helps determine whether further biological testing is needed or can be scientifically waived.
Identifying and quantifying chemical constituents released by the device.
Quantifying the nature, duration, and extent of patient exposure.
Cross-referencing known compound toxicity data where available.
Flagging where additional analytical work is needed.
Conditions are set to reflect your device's material, use, and patient contact.
Extractables and leachables are identified and quantified.
Findings are contextualized against your device's clinical use.
Data is structured for direct use in your Toxicological Risk Assessment.
A full extractables/leachables chemical profile.
Toxicologically relevant compound identification and quantification.
An interpreted summary connecting findings to your device's risk profile.
Data structured for direct use in your Toxicological Risk Assessment.
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