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Sterilization: Healthcare products. be evaluated as required by ISO 10993-7.Aligning Global Regulatory Strategy to Decrease Approval Time in Emerging Markets ISO 10993-7:2008 Biological Evaluation of Medical Devices Part 7: Ethylene Oxide.Ethylene oxide is commonly used as a sterilant causing companies to show evidence that (ETO) ethylene oxide and its common degradants (ECH) ethylene chlorohydrin and (EG) ethylene glycol do not exist in the product and packaging.13 Biological evaluation of medical devices, Part 7: Ethylene oxide sterilization residuals. (ANSI/AAMI/ISO. safety evaluation of ethylene oxide and...

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