Chemical characterization of materials is a part of the overall biological safety of a medical device, which can be applied in the identification of materials and the qualitative and quantitative analysis of chemical substances present in materials or finished medical devices.
By means of chemical characterization, some long-term tests in biocompatibility tests can be exempted, such as subchronic toxicity, chronic toxicity, long-term implantation, etc.
Chemical characterization services of medical device materials
- Qualitative of medical device manufacturing materials
- Characterization of manufacturing materials through qualitative and quantitative chemical composition of materials
- Medical device characterization for chemical substances introduced during manufacturing process (e.g. processing aids, process contaminants, sterilization residues)
- Estimation of the possibility of releasing chemical substances from medical devices or their manufacturing materials under clinical condition of use
- Determination of chemical substances released by medical devices under clinical condition of use
Standard ISO 10993-18 and GB/T16886.18
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