Residual EO/ECH Analysis

Any medical device that is sterilized by ethylene oxide (EO) and comes in contact with a patient must undergo residual testing to analyze the EO residual levels. The residues can be harmful to the end user or patient, so it is important that all devices meet the limits set forth in the ISO 10993-7 standard. The limits will vary depending upon the intended use of the device. The study should be reviewed periodically, typically with the sterilization process validation, i.e. annually 

We do the test with out partner IETQAN 

A European Authorised Representative (E.A.R.) serves as a legal entity designated by non European Union (EU) manufacturers, to represent them in the EU and ensure their compliance with the European Directives/Regualtions

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Roald Dahllaan 33 , 5629MC , Eindhoven , The Netherlands 

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