Historical
DIN EN ISO 10993-7 Berichtigung 1:2011
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008); German version EN ISO 10993-7:2008, Corrigendum to DIN EN ISO 10993-7:2009-02, German version EN ISO 10993-7:2008/AC:2009
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 and 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 this standard.
Deutsches Institut für Normung [din]