NBN EN ISO 10993-7:2008
Active , Modified Standard
Most Recent

NBN EN ISO 10993-7:2008

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

Summary

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.

Technical characteristics

Publisher Bureau de Normalisation Belge (NBN)
Publication Date 12/17/2008
Cancellation Date 10/15/2011
Page Count 111
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ISBN ---
Weight (in grams) ---
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