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Understanding Worst-case Conditions in ISO 18562 Testing

Published In: Medical Design & Outsourcing

For three decades, the ISO 10993 international standard series has provided the overarching guidance on evaluating medical devices for biocompatibility. The new international standard, ISO 18562, addresses gaps. Here’s what you need to know.

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Matthew R Jorgensen, Ph.D.

Chemistry and Materials Scientist

Dr. Jorgensen is an expert in chemistry and materials science. He has over a decade of experience designing, synthesizing, and analyzing complex materials. To characterize materials, Dr. Jorgensen has extensively used a wide variety of techniques including GC/MS, LC/MS, FTIR, UV/VIS, SEM, NMR, and several types of advanced spectroscopic techniques. His Ph.D. in Physical Chemistry from the University of Utah was based on the fabrication and analysis of titanium dioxide and silicon dioxide photonic crystals templated from the three-dimensional structure found in the exoskeleton of exotic weevils. During his time at the University of Utah, he received the Henry Eyring Research Fellowship, the DOW Chemical First Year Scholarship, and additional grants to travel and present his research at national and international conferences. His research has resulted in over 30 peer-reviewed publications.


Erin Bakes

Erin Bakes is an associate technical consultant with the Technical Advisory Group at Nelson Labs and has been part of the medical-device industry for 17 years. Prior to her role in consulting, Erin was the department manager for the Nelson Labs chemistry group, where she oversaw operations for various analytical-test methods, method development, and equipment validations. Erin joined the Technical Advisory Group in 2017 as a technical consultant for cleaning validations for newly manufactured devices and chemical characterizations with extractable and leachable analysis. Erin is a member of the ASTM F04 technical committee for medical and surgical materials and devices. She also participated on the ISO/TC 150 working group for 19227:2018 Implants for surgery – Cleanliness of orthopedic implants – General requirements.