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Abstract from Nitinol 2018: Corrosion – Key Variables, Test Methods, and Regulatory Aspects

Corrosion performance continues to be a key element of nitinol device development; this presentation gives an overview of the subject. The poor corrosion performance of some very early nitinol vascular devices focused much attention on material micro‐cleanliness and surface quality ‐ the importance of inclusion control and surface finishing, such as electropolishing and passivation, are therefore described.

 

Examples of different surface finishes and corresponding corrosion behaviours are presented. Basic corrosion mechanisms and standard test methods are briefly reviewed as well as the perspective on key parameters, acceptance levels and in‐vivo applicability of the data. The benefit of supplementing corrosion data with surface analysis is described. The importance of nickel allergy is discussed as well as addressing nickel leaching in the context of current FDA guidance.

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Barry O’Brien. Biomedical Engineering, NUI Galway, Ireland 

[email protected]

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