Reference number
ISO 10993-7:2008
© ISO 2025
International Standard
ISO 10993-7:2008
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
Edition 2
2008-10
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Published (Edition 2, 2008)
This publication was last reviewed and confirmed in 2016. Therefore this version remains current.

ISO 10993-7:2008

Language
Format
CHF 221
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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
     : Published
    Publication date
     : 2008-10
    Stage
    : International Standard to be revised [90.92]
  • Edition
     : 2
    Number of pages
     : 86
  • Technical Committee :
    ISO/TC 194
    ICS :
    11.100.20 
  • RSS updates

 Amendments

Amendments are issued when it is found that new material may need to be added to an existing standardization document. They may also include editorial or technical corrections to be applied to the existing document.

Amendment 1

Applicability of allowable limits for neonates and infants

Edition 2019

Language
Format
CHF 18
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Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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