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ISO 10993-7:1995

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

Specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices and procedures for the measurement of EO and ECH. Does not apply for EO-sterilized devices that have no patient contact such as in vitro diagnostic devices.

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