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ISO 10993-7:2026 versus ISO 10993-7:2018+A1:2022
Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
General information
Valid from 18.08.2026
Directives or regulations
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With the publication of ISO 10993-7:2026, manufacturers now have a revised international standard for evaluating EO sterilization residuals. ISO lists ISO 10993-7:2026 as the third edition, published in April 2026, and describes it as the current standard for allowable limits, measurement procedures and conformity determination for residual EO and ECH in EO-sterilized medical devices.
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Biological evaluation of medical devices
Part 7: Ethylene oxide sterilization residuals
