Draft International Standard
ISO/DIS 10993-7
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
Reference number
ISO/DIS 10993-7
Edition 3
International Standard
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ISO/DIS 10993-7
This Draft International Standard is in the enquiry phase with ISO members.
Will replace ISO 10993-7:2008

ISO/DIS 10993-7

ISO/DIS 10993-7
CHF 129
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ISO 10993-7:2008 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 the standard is applied are also included in informative annexes.

EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by ISO 10993-7:2008.

General information

  •  : Under development

    You can help develop this draft international standard by contacting your national member

    : DIS ballot initiated: 12 weeks [40.20]
  •  : 3
     : 118
  • ISO/TC 194
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This standard contributes to the following Sustainable Development Goal

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