Biocompatibility Tests

Biocompatibility is expressed as the optimum compatibility of a medical device without causing any physical, chemical or biological damage to the living body. The term biocompatibility is used to describe the appropriate biological requirements of a biomaterial or biomaterials used in a medical device. In addition to fulfilling the requirements of the intended use, the biocompatible and minimal side effects of a medical device determine the clinical performance of the device.

Medical devices that are implanted in a living system and that are designed to partially or completely assume the functions of organs and tissues; It must be compatible with the biological characteristics of the living thing, not toxic and carcinogenic, chemically inert and stable, having sufficient mechanical strength, adapting to life for a long time, and having an appropriate weight and density.

Biocompatibility tests have a very important place in biological risk assessment. The goal of all pharmaceutical, cosmetic and medical device manufacturers is to provide maximum benefit to patients while minimizing biological risk levels. It requires products and devices of this type to comply with comprehensive biocompatibility testing requirements set by international regulatory agencies to ensure they are safe for medical use before being placed on the market.

The biocompatibility performances and tests of pharmaceuticals, cosmetics, and medical devices are carried out by our laboratory by the ISO 10993 Biological Evaluation of Medical Devices standard series. The ISO 10993 standard series is generally known as the most accepted biocompatibility test reference worldwide. On the other hand, in some specific countries (eg. China, USA, Canada) biocompatibility testing requirements may differ.