Webinar questions

BiocompCHATibility vor 6 Jahren

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37:17

Podcast

BiocompCHATibility

38 Episoden

A podcast dedicated to medical device biocompatibility

Wissenschaft Gesundheit & Fitness

Podcast aneignen

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/

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