ISO 10993-7:2008/Cor 1:2009

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ISO 10993-7:2008/Cor 1:2009 is an international standard that specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in medical devices that have been sterilized with ethylene oxide (EO). It also outlines procedures for measuring these residuals and methods for ensuring compliance, according to ISO. The standard includes details on how to establish these limits, considering factors like the type of device and patient population.