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EVS-EN ISO 10993-7:2008+A1:2022

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008 + ISO 10993-7:2008/Amd 1:2019)

General information
Valid from 01.02.2022
Base Documents
ISO 10993-7:2008; EN ISO 10993-7:2008; ISO 10993-7:2008/Cor 1:2009; EN ISO 10993-7:2008/AC:2009; ISO 10993-7:2008/Amd 1:2019; EN ISO 10993-7:2008/A1:2022
Directives or regulations
None
Standard history
Status
Date
Type
Name
01.02.2022
Main + amendment
01.02.2022
Amendment
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. NOTE This part of ISO 10993 does not specify limits for ethylene glycol (EG).
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