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Home » Extraction Expertise for Medical Device Chemical Characterization
Extractable studies are performed on medical devices to evaluate potential chemical release from a medical device during clinical use.
The primary guidance for medical device extractable studies is ISO 10993-18 “Chemical characterization of medical device materials within a risk management process”. In this international standard, a number of extraction study approaches are laid out, which are applied to medical devices based on the intended device use.
EAG offers advanced expertise and a risk-based approach for medical device extractable study design and execution, including the latest FDA expectations.
ISO 10993-18 provides guidance for the type of extraction study necessary for chemical characterization, based on device contact.
In our interconnected and changing world, it is important to know how to respond to potential electronic system failures.
In this webinar we introduce latch-up testing which is relevant for CMOS devices with high static power dissipation.
July 30, 2024
Please join us for coffee and conversations! Enjoy a cup of coffee and refreshments as you get to know our technical experts.
The elemental purity of boron carbide can be measured using several methods offered by Eurofins EAG Laboratories
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