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Chris Parker, M.S, M.B.A. (Study Director and Associate Director, Toxikon)
Location: Tech Theater, Booth 155
Date: Thursday, April 19
Time: 11:30am - 12:15pm
Free Content & Activities: Tech Theater
Vault Recording: TBD
Evaluating all considerations of a testing program prior to initiation is both critical to success and a requirement of ISO-10993-1. ISO-10993 biocompatibility testing has increasingly become a risk based process with the requirements to understanding device intended use and material composition more and more of an interdependent relationship. Once an evaluation and test plan has been established and a device is ready for testing, a series of considerations related to ensuring the compatibility with a device with the various test systems should be performed. These considerations require an in-depth knowledge of your device and knowing the details to provide your biocompatibility lab can help assure accurate assessments and minimize interruptions to the testing schedule. Examples of these considerations include compatibility with the extraction vehicles and condition selected (material changes, degradation, discoloration etc.), rubber components in a device which is a positive control in cytotoxicity testing, and device size in relation to available vasculature for in-vivo thrombogenicity testing. Case studies of the test strategies and potential results of different devices will be presented.