Biocompatibility testing or ‘Biological Evaluation of Medical Devices’ (as set out in ISO standard series 10993) is a set of guidelines and testing parameters for assessment of medical device safety before any medical device comes to market. The standard uses a risk management approach for each device, reviewing existing data on materials and conducting supplementary tests where appropriate. It is necessary to look at how the medical device will be used; specifically, what the nature of the body contact will be, and the contact duration.
The ISO 10993 implications must be considered from the outset of medical device design, and the balance struck between device functionality and toxicity to the body. Assessment of other influencing factors such as leachables, residues and contaminants should also be considered at this stage.
While we now offer a full suite of medical device testing (including genotoxicity, haemocompatibility, and the USP Plastics class I-IV series), the biocompatibility test that we perform most frequently is 10993-5; the in vitro Cytotoxicity Test. This test was introduced as part of our commitment to the use of alternative methods wherever possible and allows us to use a non-animal model to assess any potential detrimental effects of medical devices or their components, in a highly controlled manner.
We are proud of our extensive knowledge and experience in this field; as such, we can advise on the most appropriate methods for the testing of your medical device. If your biocompatibility testing requirements cannot be fully conducted in-house, we also work with several approved partners to provide additional testing methods, such as those required within the ISO 10993 series. This would be conducted as a multi-site GLP study in most cases.
Please follow the links in the sidebar for more specifics on the testing we can perform to assess the biocompatibility of your device.