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    Stability Testing

    Studies that establish how device performance and packaging hold up over time.

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

    Definition

    Stability testing - including accelerated aging (often per ASTM F1980) and real-time aging - generates data to support shelf-life claims, packaging integrity, and continued sterility for terminally sterilized devices.

    What this means in practice

    Real-time data must eventually replace accelerated estimates. Stability data supports labeling claims and is reviewed during 510(k)/PMA submissions and Notified Body audits.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    ASTM·1ISO·1IMDRF/GHTF·1
    1. 1
      ASTM F1980
      Verified
      ASTMastm.org
    2. 2
      ISO 13485 Standard Page
      Verified
      ISOiso.org
    3. 3
      GHTF/IMDRF Process Validation Guidance
      Verified
      IMDRF/GHTFimdrf.org

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