English French Home » Activities » Control of ethylene oxide residues Control of ethylene oxide residues Thanks to an efficient installation and a specialized team, STERISERVICES offers you the possibility of carrying out dosages of gas residues allowing you to market your products without risk for the patient. Description of the equipment: Perkin Elmer ® Gas Chromatograph comprising a 50 m long capillary column operating in Headspace. Sample changer for analyzing up to 40 samples in a single run. Reference standards: The ISO 11135 (2007) standard requires proof that the level of gas residues after sterilization (and where applicable after aeration) is below the specified limits. The international standard ISO 10993-7 (1996) provides, per medical device and according to its duration of contact with the patient, the limits of residual ethylene oxide, ethylene hydrochloride and ethylene glycol not to be exceeded. Note that this standard has just been updated in October 2008 aimed at restricting the level of admissible residue. The dosage method: Exhaustive extraction method in order to recover all of the residues and therefore to place oneself in the most unfavorable conditions. The assay method must be validated. Services offered: Dosages on products sterilized on our site but also on products from all over the world (consult us for the transport conditions of the samples). Aeration validation including validation of the assay method and validation of aeration time and conditions. Routine assay including validation of the assay method and assays after routine sterilizations. Verification of the effect of successive cycles on the level of gas residues. Menu News Presentation Activities EtO sterilization Steam sterilization Control of ethylene oxide residues Industrial ultrasonic cleaning Packaging of medical devices Storage and logistics Contact us Certificates Our team Our values Recruitment Location Our links Our video Our presentation Customer Area Sterilization space Stock space Production area Copyright 2016 Steriservices Legal Notice Contact us Sitemap