ISO/AWI 10993-7
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ISO/AWI 10993-7
84824

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 

  •  :  Under development
  •  : 3
  •  : ISO/TC 194 Biological and clinical evaluation of medical devices
  •  :

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal:

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