90.92 Standard to be revised Mar 16, 2022
ISO/TC 194 Biological and clinical evaluation of medical devices
11.100.20 Biological evaluation of medical devices
ISO 10993-7:2008 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released. Additional background, including guidance and a flowchart showing how the standard is applied are also included in informative annexes.
EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by ISO 10993-7:2008.
90.92 Standard to be revised
Mar 16, 2022
ISO 10993-7:2008/Cor 1:2009
ISO 10993-7:2008/Amd 1:2019