Biological evaluation of medical devices - Ethylene oxide sterilization residuals
Biological evaluation of medical devices - Ethylene oxide sterilization residuals
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1 Scope 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 and guidance also is included in informative annexes. EO-sterilized devices that have no patient contact (e.g. in vitro diagnostic devices) are not covered by this International Standard.
Упомянутые в описании и другие стандарты BS