Medical Devices need to assess the biocompatibility of their medical device materials and processes by taking a risk-based approach to their biological safety evaluations.
The main objective of biocompatibility testing is the protection of man against potential biological hazards by the use of medical devices through a biological evaluation, compilation of historical data, and reference tests. This allows to perform a comprehensive assessment of biological responses for each medical device in relation to its safety.
The term "medical device" goes from simple component to complex instrument of many components and materials.
The tests required to verify biocompatibility differ by type of device (surface contact, implantable), type of contact (skin, mucous membrane, wound area, tissue, bone, dentine, bloodstream, blood...), the contact time (limited, prolonged or permanent) and the historical data existing on the material used.
Biocompatibility Testing can be divided into the following three steps:
- Risk Identification (Biological Evaluation Plan).
- Risk Mitigation through testing (Biological evaluation of your medical device).
- Evaluation of results (Biological Evaluation Report).
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