ISO/DIS 10993-7

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.

SDO:

ISO

Language:

English

ICS Codes:

11.100.20

Status:

Draft

Publish date:

1969-12-30

Standard Number:

ISO/DIS 10993-7