Biological Assessment Plan (BEP)

Due to the contact of the medical devices with the tissue, it must pass the tests and analyzes and prove that it does not harm the tissue. Biological Evaluation study should be carried out in accordance with EN ISO 10993-1 Series Standards.

We can evaluate that medical devices are not harmful in contact with tissue with biocompatibility tests. In fact, with the Biological Evaluation Study, the Medical Device Manufacturer proves its biocompatibility by passing the relevant tests within the scope of the EN ISO 10993-1 standard, taking into account the body tissues that its products come into contact with, the contact time and the structure of their products.

Biological evaluation in medical devices. Annex-B and Annex-C sections of the Standard should be taken as a basis while making The content of the evaluation should be made by including the following topics.

Physical and chemical characteristics of various materials that are candidates for use;

• Production material, additives, process pollutants and residues from raw material to final product,
• History of clinical use and human exposure data,
• Filtrate,
• Decomposition products, other components and their interactions in the final product, porosity, particle size, shape and surface morphology results ,
• Performance and characteristics of the final product,
• Physical characteristics of the product and its component materials, decomposition products and physical characteristics without limitation of any toxicological and other biological safety data available on metabolites.