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Full Description

This standard 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.
 

Document History

  1. AAMI/ISO 10993-7:2008/(R)2012


    Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals, includes Errata (2010)

    • Most Recent
  2. AAMI/ISO 10993-7

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    Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals - SAME AS ISO 10993-7

    • Historical Version