Chemical Characterization (T)

In order to protect against potential biological risks arising from the use of medical devices, it is an obligatory practice to carry out a biological compatibility assessment in medical devices. Chemical characterization offers the possibility of preliminary evaluation for biological evaluation.

Biological Evaluation of Medical Devices according to ISO 10993

The ISO 10993 series of standards includes biological evaluation of a medical device within the risk management process as part of the overall evaluation and development of a medical device. It can be applied to all active, inactive, implantable or non-implantable devices. The ISO 10993 series of standards covers biological assessments and related tests and special aspects.

Chemical Characterization

In some cases, chemical characterization helps support the biocompatibility testing process and reduce the use of animal testing. In some cases, it can eliminate the necessity for some of the biocompatibility tests and save time and cost. Biocompatibility tests focused on the biological effects of compounds extracted from devices on animals or cells. Chemical characterization, on the other hand, aims to determine the amount of chemicals extracted from the medical device by measuring it with analytical devices and to evaluate the exposure levels and toxicological risks.

For chemical characterization, testing methods are used using direct material characterization (such as FTIR, DSC) and extraction methods (analytical test after extraction with polar or apolar solvents, GC-MS, LC-MS, ICP-MSGravimetric methods).

Obtained test data are analyzed for toxicological risk and patient safety. Results for each chemical should meet criteria for no adverse effects observed.

Chemical Characterization of Medical Devices according to ISO 10993-18

The chemical characterization requirement is specified in ISO 10993-1. Chemical characterization is not required if a product does not have direct or indirect contact with the patient. When necessary, information collection, evaluation and testing processes are initiated for chemical characterization. It is examined whether the results support a toxicological risk assessment conclusion or equivalence that it poses an acceptable health risk.