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Chemical CharacterizationChemical Characterization: How to Appropriately Initiate the Biological Evaluation of Medical Devices Considering the Recent Revisions of ISO 10993-1 and ISO 10993-18

Chemical characterization is the initial step in the biological evaluation of any medical device with direct or indirect patient contact. If a chemical characterization assessment on a medical device is conducted and evaluated appropriately, it can potentially minimize the need for additional biological testing. The recent revision to ISO 10993-1 highlights the importance of chemical characterization and the ongoing revisions to ISO 10993-18 provide more detail on how to appropriately carry out this assessment.

This presentation will provide a framework on how to appropriately chemically characterize a device including: An overall step by step guide through the characterization procedure, details on how to perform an appropriate extractables or leachables study, as well as examples of actual application of the standards in case studies. 

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View recordings of our past seminars

Container-Closure Integrity Testing for Drug Delivery Devices

Package Testing: Developing a Test Plan that does not Delay Product Launch

Changes in Europe's Medical Device Regulations: Consequences for Manufacturers

Developing Test Strategies Per the New ISO 10993-1: Current Status & Upcoming Changes

Chemical Characterization: The Starting Point for Biological Evaluations

Biocompatibility Basics: Making Sense of the Annex A Matrix

Developing a Testing Plan for Medical Device Design Verification

Endotoxin Testing: Make Sure FDA's New Guidance Doesn't Delay Your Product Launch