French Regulator Increases Scrutiny Of Compliance With EtO Standard For Residue Levels
This article was originally published in Clinica
Executive Summary
Companies that are selling neonatal and pediatric medical devices in France and sterilizing the devices with ethylene oxide (EtO) need to be vigilant and ensure they are in compliance with the European EtO standard for residue limits. Otherwise, these companies risk their products coming under the scrutiny of the local healthcare product agency, the ANSM, and potentially being banned from the French market because of the carcinogenic threat these residues pose.
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