The biocompatibility is a preclinical aspect important for any medical device in contact with the human body. The subject is generative of numerous questions and discussions. That is why this webinar gives the methodology expressed in the NF EN ISO 10993-1 (2010) standard and has for objective to harmonize the demonstration of the control of the biological risk.
During this webinar, the following issues will be discussed:
- Global approach,
- General principles of the standard,
- Proposed assessment methodology,
- Documents of the LNE/G-MED related to the audit and to the evaluation of files.