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ANSI/AAMI/ISO 10993-7:2008 (R2012)

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

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.


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Association for the Advancement of Medical Instrumentation [AAMI]


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