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.
A Haystack with No Needle: Is an Extractables Study Appropriate for Limited-Contact Devices?
Published In: Medical Device and Diagnostic Industry (MD+DI)
June 7, 2022