Abstract

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 

  • Status
     : Under development
  • Edition
     : 3
  • Technical Committee
     : ISO/TC 194 Biological and clinical evaluation of medical devices
  • ICS
     :
    11.100.20 Biological evaluation of medical devices

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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  3. Standards catalogue
  4. ICS
  5. 11
  6. 11.100
  7. 11.100.20
  8. ISO/CD 10993-7.2