The wind is blowing on the normative landscape of biocompatibility.

After the publication of ISO 10993-18: 2020 on physico-chemical characterization, here are ISO 10993-23: 2021 relating to irritation and which will replace partially ISO 10993-10: 2010, remaining in force for sensitization assessment and the technical update of ISO 10993-12: 2021. The main difference of this new standard on irritation with the previous one is to introduce in vitro method of evaluation. Even if they these standards are not harmonized, they are representing the state of the art and must therefore be taken into account.

Failure to do so will affect the quality of your biological evaluation. The 2 versions have thus to be referenced in your lists of applicable / applied standards