This International Standard specifies requirements and test methods to enable current knowledge to be used to determine whether elastomeric impression materials, as manufactured for final sale, are of the quality required for their intended use. NOTE This International Standard does not consider possible biological risks posed by the material. To assess possible biological risks, it is recommended to use ISO 7405 and ISO 10993.
EN ISO 4823:2015 Referenced Document
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process