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download between 0-24 hoursReleased: 2008
ISO 10993-7:2008
ISO 10993-7:2008-Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals
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English Hardcopy
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French Hardcopy
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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.