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    ISO 11135

    Standard for development, validation, and routine control of ethylene oxide (EO) sterilization.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    ISO 11135 specifies requirements for EO sterilization processes for medical devices, including microbiological qualification, dose setting, process challenge devices, and parametric release options.

    What this means in practice

    EO sterilization capacity has been a persistent supply-chain risk; ISO 11135 conformance is essential to qualify alternative sites.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    ISO·2FDA·1
    1. 1
      ISO 11135
      Verified
      ISOiso.org
    2. 2
      FDA Recognized Consensus Standards
      Verified
      FDAaccessdata.fda.gov
    3. 3
      ISO Standards Catalogue - Health
      Verified
      ISOiso.org

    Inline markers like [1] jump to the matching reference above.