Biological Assesment Study
The medical device producer is responsible to prove that their medical devices would not cause any harm to the tissue in case it contacts with the tissue. Accordingly, biological assessment study should be conducted based on the EN ISO 10993-1 Standard.
This process is often perceived as to have the biocompatibility tests done by the medical device producers. In fact, with the biological assessment study the medical device producer determines which tests of the EN ISO 10993-1 standard table A.1 will he/she have it done and on what grounds in deference to the body tissues that the products contact with, contact time and the structure of the products and in parallel to his/her decision justifies the product biocompatibility by the
biocompatibility tests which the producer has it done if necessary.
Through the correctly conducted biological assessment study, the medical device producer can save himself/ herself from high test costs that will come up, although these tests are not a necessity, thus prevents the waste of many experiment animals that will be used during these tests.
Biological assessment process is carried out based on the ANNEX-B and ANNEX-C sections of the standard. Issues that are stated below should certainly be included to the assessment content.
- Physical and chemical characteristics of various materials that are candidate to usage
- History related to the clinical usage and exposure to humans
- Any current toxicological and other biological safety information about the product and component materials, disruption products and metabolites
- Experiment processes
- Production material/ materials
- Designed preservatives, process contaminators and residues
- Filterable materials
- If any degradation products
- Other components and their interactions at final product
- Performance and characteristics of the final product
- Physical characteristics including but not limited to the porosity, particle size, shape and surface morphology of the final product