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A Haystack with No Needle: Is an Extractables Study Appropriate for Limited-Contact Devices?

Published In: Medical Device and Diagnostic Industry (MD+DI)

With the update to ISO 10993-18, is an extractables study required for all medical devices regardless of contact type and duration of contact? In this article, Helin Räägel, Matthew R Jorgensen, and Thor Rollins from Nelson Labs share insights on the new requirement for physical or chemical information and what it means for manufacturers.

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