Biocompatibility is, by definition, a measurement of how compatible a device (material) is with a biological system. Biocompatibility refers to the tendency of these products to remain biologically inert throughout the duration of their contact with the body. At present, DL has the requisite expertise to deliver biocompatibility studies as per ISO and USP-NF.
"The primary aim of this part of ISO 10993 is the protection of humans from potential biological risks arising from the use of medical devices."
Medical devices and their component materials may leach compounds or have surface characteristics that may produce undesirable effects when clinically. The biocompatibility testing procedures are designed to detect the nonspecific, biologically reactive, physical or chemical characteristics of medical products or the materials used in their construction. In combination with chemical assay, these biological procedures can be used to detect and identify the inherent or acquired toxicity of medical products prior to/or during their manufacturing and processing.
Non-clinical testing procedures to evaluate the safety of the metals, elastomers, plastics, or other polymers used in the construction of medical products
- Cytotoxicity Test
- Skin Sensitization Test (GPMT)
- Skin, Mucous Membrane & Eye Irritation Studies
- Intracutaneous Reactivity Test
- Acute Systemic Toxicity Test
- Pyrogenicity Test