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ISO 10993-7:2008

ISO 10993-7:2008

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

Published By Publication Date Number of Pages
ISO 2008-10 94
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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.

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ISO 10993-7:2008
$55.25