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NS-EN ISO 10993-7:2008

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

standard by Standards Norway NS-EN ISO , 02/01/2009

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ADOPTED_FROM:EN ISO 10993-7:2008 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.

Product Details

Published:: 02/01/2009
Number of Pages:: 104
File Size:: 1 file , 2.3 MB
Product Code(s):: 856514e3-a2f9-4bd6-ace2-490f95f1c891, 856514e3-a2f9-4bd6-ace2-490f95f1c891, 856514e3-a2f9-4bd6-ace2-490f95f1c891