ISO 10993-7 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
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ISO 10993-7 Document Information:
Title
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
International Organization for Standardization
Publication Date:
Oct 15, 2008
Scope:
This part of ISO 10993 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 this document is applied, are also included
in the informative annexes.
EO-sterilized devices that have no patient contact (e.g., in
vitro diagnostic devices) are not covered by this part of ISO
10993.
NOTE This part of ISO 10993 does not specify limits for ethylene
glycol (EG).
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