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    ISO 11607-1/-2

    Standards for sterile barrier systems for terminally sterilized medical devices.

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

    Definition

    ISO 11607-1 specifies requirements for materials, sterile barrier systems, and packaging systems. ISO 11607-2 covers validation requirements for forming, sealing, and assembly processes.

    What this means in practice

    Co-cited with sterilization standards in FDA Recognized Standards; packaging changes commonly drive Letter-to-File vs new submission decisions.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    ISO·1IEC·1AAMI·1
    1. 1
      ISO 11607-1
      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.