ISO/FDIS 10993-7

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ISO/FDIS 10993-7 is a draft international standard within the ISO 10993 series, focusing on the biological evaluation of medical devices. Specifically, it addresses the residual Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) in medical devices that have been sterilized using EO. It specifies allowable limits for these residues, procedures for their measurement, and methods for determining compliance.