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.
Status: Under development
Technical Committee: ISO/TC 194 Biological and clinical evaluation of medical devices
- ICS :
- 11.100.20 Biological evaluation of medical devices
This standard contributes to the following Sustainable Development Goal:
ISO 10993-7:2008/Amd 1:2019Published
ISO 10993-7:2008/Cor 1:2009
ISO/CD 10993-7Stage: 30.60
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