60.60 Standard published Oct 15, 2008
CEN
CEN/TC 206 Biological and clinical evaluation of medical devices
European Norm
11.100.20 Biological evaluation of medical devices
Published
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
WITHDRAWN
EN ISO 10993-7:1995
PUBLISHED
EN ISO 10993-7:2008
60.60
Standard published
Oct 15, 2008
IN_DEVELOPMENT
prEN ISO 10993-7
