Innovative Product Design: Don't Forget Cleanability!
Advancements in design and manufacturing technologies is fostering an age of unprecedented innovation in the development of reusable medical devices and instruments. As designers develop smaller, more complex and intricate devices, companies must not overlook the importance of ensuring these products can be effectively cleaned and disinfected before being reused. In fact, this cleaning process must be validated by the manufacturer before the product can be released into the marketplace.
This presentation will discuss how companies can ensure their innovative designs for reusable medical devices meet safety regulations for cleanability and reprocessing.
Chemical 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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