Answering Your Questions on ISO 10993-18:2020

Operating room with monitor

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Audio

BiocompCHATibility

A NAMSA podcast series that addresses specific medical device evaluation scenarios and challenges.


During this episode, our hosts are joined by Andy Wyen, Toxicologist at NAMSA, to answer questions received during NAMSA’s live Webinar on the new ISO 10993-18:2020. As this new standard is a complete re-write from the 2005 version, it is stirring up industry and leaving many manufacturers confused and searching for the most efficient adoption methods.

Topics include:

  • Triplicate testing and how to determine if there is low variability in a sample before extraction has occurred
  • AET: How to calculate the number of devices used in clinical use for a chronic device that can be used during someone’s lifetime
  • Whether NVR used to establish exhaustive conditions affect the AET calculation for analysis
  • Whether the same replicates (single, duplicate, and triplicate) apply to NVR

With the release of 10993-18:2020 on January 15, 2020, it is crucial for professionals involved with the Biological Evaluation of medical devices to understand the standard’s use, interpretation and requirements, as well as how an effective link now exists to the overall Biocompatibility Evaluation as described in ISO 10993-1.

Connect with Andy: https://www.linkedin.com/in/andy-wyen-3448486/

Also be sure to check out our Biocompatibility Strategy Navigator.

Andy Wyen, M.S., DABT

Andy Wyen, M.S., DABT

Andy Wyen is currently a Toxicologist at NAMSA. Through his 15 years in the industry, he has held various positions, such as R&D technician, Chemist and Biocompatibility Study Director. Andy's expertise includes analytic chemistry, chemical characterization, biocompatibility and toxicology. He obtained his Bachelor and Master degree in Pharmacology/Toxicology from the University of Toledo (OH).

Sheri Krajewski

Sheri Krajewski

Sheri joined NAMSA in 2003 and currently serves as Senior Global Product Marketing Manager of Biological Safety. Sheri has supported customers in a variety of commercial operations and management roles, and was an integral leader in the development of NAMSA’s Biological Safety Consulting business. Additionally, she created the much sought-after NAMSA Training Series (NTS) for the iological evaluation of medical devices. Prior to NAMSA, Sheri was the marketing lead for a mechanical fatigue laboratory and consulting business where she worked primarily with cardiovascular implant manufacturers. Sheri holds a Bachelor’s Degree from the University of Nebraska.

Don Pohl

Don Pohl

Don Pohl is currently the Manager of Biological Safety & Validation at NAMSA. He holds a Bachelor’s degree from Ohio State University. Don has over 20 years of experience in the pre-clinical evaluation of medical devices for biological safety. During his career, he has held a variety of positions ranging from laboratory supervision/management, GLP Study Director, Technical Specialist for Laboratory Information Management System, Technical Specialist and project manager for Biological safety and biological risk assessment consultation. He has specific expertise in the evaluation process outlined in ISO 10993-1 as well as the expectations of the USFDA and other countries in their interpretation of the biological safety evaluation of medical devices.