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: PublishedPublication date: 2008-10
Edition: 2Number of pages: 86
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:
Buy this standard
|std 1 208|
|std 2 208||Paper|
A standard is reviewed every 5 years
Stage: 90.92 (To be revised)
Corrigenda / AmendmentsPublished
ISO 10993-7:2008/Amd 1:2019Published
ISO 10993-7:2008/Cor 1:2009
Will be replaced byUnder development
Got a question?
Check out our FAQs
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)
Keep up to date with ISO
Sign up to our newsletter for the latest news, views and product information.