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
Draft
International Standard
ISO/DIS 10993-7
84824
This Draft International Standard is in the enquiry phase with ISO members.
Will replace ISO 10993-7:2008

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
    : DIS registered [40.00]
  •  : 3
     : 118
  • ISO/TC 194
    11.100.20 
  • RSS updates

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

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