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    ISO 11137

    Standard for radiation sterilization of healthcare products.

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

    Definition

    The ISO 11137 series (Parts 1, 2, 3) specifies requirements and guidance for development, validation, and routine control of gamma, X-ray, and electron beam sterilization processes.

    What this means in practice

    Demand for non-EO sterilization is growing; many manufacturers now maintain dual capability and qualify both routes.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    ISO·1IEC·1AAMI·1
    1. 1
      ISO 11137-1
      Verified
      ISOiso.org
    2. 2
      IEC Webstore - Medical Equipment
      Verified
      IECwebstore.iec.ch
    3. 3
      AAMI Standards
      Verified
      AAMIaami.org

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