99.60 Withdrawal effective May 20, 2026
CEN
CEN/TC 206 Biological and clinical evaluation of medical devices
European Norm
11.100.20 Biological evaluation of medical devices
Withdrawn
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.
Legislation related to this standard
Active implantable medical devices
Harmonised Standard / Cited in the Official Journal
WITHDRAWN
EN ISO 10993-7:1995
WITHDRAWN
EN ISO 10993-7:2008
99.60
Withdrawal effective
May 20, 2026
PUBLISHED
EN ISO 10993-7:2026
