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Full Description

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.

 

Document History

  1. ISO 10993-7:2008


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

    • Most Recent
  2. ISO 10993-7:1995

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

    • Historical Version