Chemical Characterisation (ISO 10993-18)
Chemical Constituents Extractables Potential Toxic Substances Analyses materials used in medical devices to identify chemical constituents, extractables, and potential toxic
Chemical Constituents Extractables Potential Toxic Substances Analyses materials used in medical devices to identify chemical constituents, extractables, and potential toxic
Conducted by UK & Europe Registered & ABT-Certified Toxicologists Clear assessment for regulatory submissions Product safety documentation Integrates chemical data,
Supports biocompatibility assessments Mitigates potential patient exposure risks Ensures regulatory compliance for marketed devices Examines substances that may leach from
Impurity Degradant Evaluates potential toxic effects from impurities or degradation products that may arise during manufacturing, storage, or use, helping