ISO 10993-7:2008/Amd 1:2019

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ISO 10993-7:2008/Amd 1:2019 is a technical 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). This standard also details procedures for measuring EO and ECH, and methods for determining compliance to ensure devices are safe for patient use. A key aspect of the standard, particularly with the 2019 amendment, is the application of these limits to devices intended for use in special populations, such as neonates and infants, where body weight and exposure factors are considered.