AAMI 10993-7

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Biological evaluation of medical devices-Part 7: Ethylene oxidesterilization residuals
8th Edition, 2008
Includes all amendments and changes through Reaffirmation Notice , 2012

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  • Revision:8th Edition, 2008
  • Published Date:January 2012
  • Status:Active, Most Current
  • Document Language:English
  • Published By:Association for the Advancement of Medical Instrumentation (AAMI)
  • Page Count:114
  • ANSI Approved:Yes
  • DoD Adopted:No
  • This part of ISO 10993 specifies allowable limits for residualethylene oxide (EO) and ethylene chlorohydrin (ECH) in individualEO-sterilized medical devices, procedures for the measurement of EOand ECH, and methods for determining compliance so that devices maybe released. Additional background, including guidance and aflowchart showing how this document is applied, are also includedin the informative annexes.

    EO-sterilized devices that have no patient contact (e.g., invitro diagnostic devices) are not covered by this part of ISO10993.

    NOTE This part of ISO 10993 does not specify limits for ethyleneglycol (EG).