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ISO 10993-7:2008Withdrawn

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

Évaluation biologique des dispositifs médicaux — Partie 7: Résidus de stérilisation à l'oxyde d'éthylène

This edition has been replaced by ISO 10993-7:2026.

Abstract / scope

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.

Life cycle

Amendments & corrigenda

ISO 10993-7:2008/Cor 1:2009WithdrawnBiological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Technical Corrigendum 1International Standard · Published 12 Nov 2009 · ISO/TC 194ISO 10993-7:2008/Amd 1:2019WithdrawnBiological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Amendment 1: Applicability of allowable limits for neonates and infantsInternational Standard · Published 9 Dec 2019 · ISO/TC 194

Replaces

ISO 10993-7:1995WithdrawnBiological evaluation of medical devices — Part 7: Ethylene oxide sterilization residualsInternational Standard · Published 12 Oct 1995 · ISO/TC 194

Replaced by

ISO 10993-7:2026PublishedBiological evaluation of medical devices — Part 7: Ethylene oxide sterilization residualsInternational Standard · Published 20 Apr 2026 · ISO/TC 194