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ISO/FDIS 10993-7

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

General information

50.00     Dec 2, 2024

ISO

ISO/TC 194

International Standard

11.100.20  

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

PUBLISHED
ISO 10993-7:2008

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

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

NOW

PROJECT
ISO/FDIS 10993-7
50.00 Final text received or FDIS registered for formal approval
Dec 2, 2024

National adoptions

naSRPS EN 10993-7:2022  
ISS

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO/DIS 10993-7:2024)

45.99   Dispatch of FV draft to CCMC

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