Module 14 2022

22/03/2022

ISO 10993 compliance for materials…

Biological evaluation of medical devices: • Evaluation and testing within a risk management process • Biocompatibility testing aspects • Framework for identification and quantification of potential degradation products • Identification and quantification of degradation products from polymeric medical devices, ceramics, metals and alloys • Establishment of allowable limits for leachable substances

Masterclass: Lecture 3

The Organisation for Professionals in Regulatory Affairs

21

ISO 10993 compliance for materials…

Biological evaluation of medical devices: Chemical characterization of materials Physicochemical, morphological and topographical characterization of materials Nanomaterials

Masterclass: Lecture 3

The Organisation for Professionals in Regulatory Affairs

22

11