Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals
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.
Document published on: 2008-10-15 Edition: 2 (Monolingual) ICS: 11.100.20 Status: Published Stage: 90.92 (2013-08-05) TC/SC: ISO/TC 194 Number of Pages: 86
Revised by: ISO/AWI 10993-7
Revises: ISO 10993-7:1995