Eurofins — Extractables and Leachables Testing for Medical Devices
Summary
Eurofins guidance on extractables and leachables testing, material characterization, and chemical risk assessment for medical devices. Covers ISO 10993-18 chemical characterization, analytical methods, and toxicological risk assessment approaches required under EU MDR.
Document Details
Document IDEUROFINS-E-AND-L
TypeWhite Paper
AuthorityEurofins
Publication Date2024-02-01