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AAMI 10993-7
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AAMI 10993-7 8th Edition, January 1, 2008 Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals
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Description / Abstract:
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).
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).