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BiocompCHATibility Podcast
Demystifying 10993:18 chemical characterization of medical device materials within a risk management process

Demystifying 10993:18 chemical characterization of medical device materials within a risk management process

BiocompCHATibility vor 6 Jahren

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Podcast

BiocompCHATibility

38 Episoden

A podcast dedicated to medical device biocompatibility

Wissenschaft Gesundheit & Fitness

Podcast aneignen

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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or former employers.