The important standards for biological evaluation and risk analysis of medical devices are explained in three parts. ISO 10993-1 provides the framework and describes the general principles of the biological evaluation; ISO 10993-18 provides information on the qualitative and quantitative characteristics and finally ISO 10993-17 gives guidance on the derivation of the allowable limits for the leachable components of the medical devices. All the three major standards are going to be revised substantially.
Based on the proposed revisions it can be foreseen that in future the chemical characterisation will be a key parameter in the assessment of the biological evaluation of medical devices within a risk management system.
Read more about this topic in our recently published paper by Dr Albrecht Poth. It is available online or download a copy free of charge here.
Poth, A (2018) Setting the standard: The challenges of biological evaluation, Medical Plastic News, 41, 31.
Medical Plastic News