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EVS-EN ISO 10993-7:2008

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

General information
Valid from 09.01.2009
Base Documents
ISO 10993-7:2008; EN ISO 10993-7:2008
Standard history
Status
Date
Type
Name
Amendment
EN ISO 10993-7:2008/prA1
06.01.2010
Corrigendum
09.01.2009
Main
This part of ISO 10993 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, are also included in the informative annexes. EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by this part of ISO 10993.
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