Medical Devices Preclinical / Biological Evaluation Training

The training covers the following standards.

• EN ISO 10993 Standard Series – Biological evaluation of medical devices (10993-1,3,4,5,6,10,11,12,23)
• PD ISO/TR 15499 Biological evaluation of medical devices – Guidance on the conduct of biological evaluation within a risk management process
• ISO 10993-18 Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process
• ISO 10993-18 Biological evaluation of medical devices – Part 12: Sample preparation and reference materials
• ISO 10993-18 Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances