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About This Item

 

Full Description

Includes a January 2010 erratum at the end.

AAMI/ISO 10993-7 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 this document is applied, is also included in informative annexes. EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by this standard.
 

Document History

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

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

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  2. AAMI/ISO 10993-7


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

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. AAMI/ISO 1099307E

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    Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals, Errata (22-Jan-2010)