Text hereIn the assessment of a medical device’s biocompatibility, acute systemic toxicity testing evaluates whether the device (or its components) could cause harmful effects in the body. Unlike local toxicity, systemic toxicity involves adverse reactions that can occur when substances from the device enter the body and impact multiple organs or systems, not just the site of contact. Such testing must be conducted in accordance with ISO 10993-11. However many manufacturers lack the in-house capabilities and specialised expertise to manage these regulatory hurdles, evolving standards, and ethical testing requirements. This can lead to testing delays, additional samples, and increased costs.

Eurofins Medical Device Services network of laboratories supports manufacturers in meeting their device’s biological evaluation plans through Biocompatibility Testing. As part of our comprehensive portfolio, we offer acute systemic toxicity testing solutions aligned with ISO 10993-11 and ISO 10993-12 standards to help assess potential adverse effects throughout the body following exposure to your medical device.

Our collaboration with a partner lab with a proven track record in systemic toxicity and biocompatibility evaluation ensures seamless access to the required in vivo studies when no viable in vitro alternative exists. Our approach combines ethical testing and regulatory precision. We advocate the principles of the 3Rs: Replacement, Reduction, and Refinement.

*Testing is performed by our partner lab.