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.
Status: PublishedPublication date: 2008-10
Edition: 2Number of pages: 86
Technical Committee: ISO/TC 194 Biological and clinical evaluation of medical devices
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A standard is reviewed every 5 years
Stage: 90.92 (To be revised)
Will be replaced byUnder development