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AAMI TIR19:1998/ A1:1999

Guidance for ANSI/AAMI/ISO 10993-7:1995, biological evaluation of medical devices -Part 7: Ethylene oxide sterilization residuals

ANSI/AAMI/ISO 10993-7 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 this document is applied, is 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.

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