Our hosts are joined this week by Dr. Ted Heise, convenor of TC 194/WG 14 responsible for the re-write and release 10993-18 Biological evaluation of medical devices —Chemical characterization of medical device materials within a risk management process. This much-anticipated standard is expected to provide greater detail and guidance to the use of characterization within the biological evaluation of medical devices.

“There are no technical changes allowed when FDIS is translated to International standard” – Ted Heise

“The distinction between chemical information and analytical testing is one of the important changes in the new document.” -Ted Heise

“You can use this standard to answer different types of questions and that a well-documented plan can justify an approach to answer one question. “ – Don Pohl

“The document includes a tabulation of solvents with varying degrees of polarity…. It also emphasizes that your solvents should not degrade your test article.” – Ted Heise Discussion points include:

• High level overview of the changes to the standard
• Discussion of the most significant changes and what it means to manufacturers
• The differentiation between material and chemical characterization
• Discussion of degradation of materials and the importance of selecting proper solvents for extraction
• Discussion of AET (Analytical Evaluation Threshold)

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