Biological evaluation of medical devices

Cytotoxicity is a biological endpoint that must be evaluated according to ISO 10993-1:2018 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) for the biological evaluation of any medical device. The cytotoxicity test according to ISO 10993-5:2009 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity) is a rapid, standardized, sensitive and cost-effective method for testing whether a medical device or its manufacturing materials contain potentially biologically harmful, material- and manufacturing-related leachables. Thus, the performance of the cytotoxicity test serves the medical device manufacturer not only to prove the biocompatibility of its product, e.g. in the context of a CE marking, but also to identify biological hazards and to assess the risk of the product already during product development, to validate product cleanliness or to prove that biocompatibility is still given after a change in product composition or manufacturing. GBA Medical Device Services from GBA Group Pharma & Medical Devices has more than 25 years of experience in product- and application-specific cytotoxicity testing, which is continuously growing thanks to the continuous participation in all relevant national and international standardization bodies, as well as the good long-term cooperation with national and international manufacturers of medical devices.

Here is a case study:

For example, we were able to provide one customer with an early conclusion that the production and cleaning process of their surgical instrument was inadequate. Based on the observed increased cytotoxic effects and confirmed by subsequent chemical analysis, we were able to work together with our customer to find a reliable clue for optimization by finding the cause of the effect in a defined section of the cleaning process (the passivation step). After adjusting the passivation process, the product successfully passed the subsequent cytotoxicity test and further tests in the context of the biological evaluation could be continued with the optimized product.