USP Plastic Class I-VI Tests
U.S. pharmacopoeial regulations mandate that all medical devices undergo biological reactivity testing to determine that the materials used in construction do not cause any adverse reactions in the human body.
Depending on which category the medical device is classed under, the required testing may include:
- Acute systemic toxicity
- Intracutaneous reactivity
- Tissue implantation
We are able to perform these tests in-house, however, prior to initiating any project, we will first conduct risk assessments and in vitro screening methods to ensure that unnecessary in vivo testing is not conducted.
At Wickham Laboratories, we are committed to reducing, refining and replacing testing in laboratory animals and have a dedicated in vitro research team investigating viable alternative methods for these types of testing.