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Homepage>ISO Standards>ISO 10993-7:2008-Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals
download between 0-24 hoursReleased: 2008
ISO 10993-7:2008-Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals

ISO 10993-7:2008

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

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Standard´s number:ISO 10993-7:2008
Pages:86
Edition:2
Released:2008
DESCRIPTION

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.