News for ISO 10993-1:Biological Evaluation of Medical Devices – Evaluation and testing within a risk management process.

ISO 10993:2009 Biological Evaluation of Medical Devices – Evaluation and testing within a risk management process has a secondary objective of avoiding redundant in-vivo tests. But even if that is true for Europe, important markets such as US and China still require that all the tests are done, so the question is whether the possibility from ISO 10993:2009 will make any real difference? Hopefully, in the long run, we will see an adoption of practice from US and China to the ISO standard.

News in the latest version of the standard is that part 1 in the standard is missing the very commonly used matrix for determining tests. The matrix is now in the annexe A, and the decision should be based on the risk analysis.

Note that there are two versions of the ISO 10993-1:2009 standard from the same year. The current version has the title Biological Evaluation of Medical Devices – Evaluation and testing within a risk management process.