To demonstrate the safety and efficacy of their products, medical device manufacturers use data from a variety of analytical, in vitro, and animal test procedures. The ISO 10993 guidelines spell out the requirements for basic biocompatibility testing of medical devices. PBL’s Assessing Biocompatibility guide can help you plan your biocomp testing program. The BioPT planning tool is especially helpful in guiding users through the decisions needed to initiate an ISO-compliant biocompatibility evaluation.

(We're proud to note that a version of Assessing Biocompatibility was published as a chapter in The Medical Device R&D Handbook by Theodore R. Kucklick.)

PBL also offers surgical support services for companies wishing to evaluate the safety and efficacy of their devices or to train physicians on proper techniques for using them.

Finally, in hopes of reducing widespread confusion on the subject, we've included a section on the USP Class Plastics tests. You often hear the phrase "USP Class VI" used as practically synonymous with "biocompatible." But in fact, the Class Plastics procedures are generally not recommended for biocompatibility assessments of medical devices.

Please feel free to contact Biocomp@PacificBioLabs.com with any questions.