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ISO 10993-7:2008

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

Publication date:   Oct 13, 2008

General information

90.92 Standard to be revised   Mar 16, 2022

ISO

ISO/TC 194 Biological and clinical evaluation of medical devices

International Standard

11.100.20   Biological evaluation of medical devices

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Published

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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

PREVIOUSLY

WITHDRAWN
ISO 10993-7:1995

NOW

PUBLISHED
ISO 10993-7:2008
90.92 Standard to be revised
Mar 16, 2022

CORRIGENDA / AMENDMENTS

PUBLISHED
ISO 10993-7:2008/Cor 1:2009

PUBLISHED
ISO 10993-7:2008/Amd 1:2019

REVISED BY

IN_DEVELOPMENT
ISO/FDIS 10993-7