Abstract
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: Under development
-
Edition: 3
-
- ICS :
- 11.100.20 Biological evaluation of medical devices
Life cycle
-
Previously
PublishedISO 10993-7:2008
PublishedISO 10993-7:2008/Amd 1:2019
PublishedISO 10993-7:2008/Cor 1:2009
-
Now
Got a question?
Check out our FAQs
Customer care
+41 22 749 08 88
Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)