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ISO 10993-7:2008

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
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ISO 10993-7:2008

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

PUBLISH DATE 2026
ISO 10993-7:2008

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.

SDO ISO: International Organization for Standardization
Document Number ISO 10993
Publication Date April 1, 2026
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 194
Publish Date Document Id Type View
April 1, 2026 ISO 10993-7:2008 Revision
April 1, 2026 Revision
Oct. 15, 2008 ISO 10993-7:2008 Revision