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    Essential Performance

    Performance of a clinical function whose loss or degradation would result in unacceptable risk.

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

    Definition

    Per IEC 60601-1, essential performance is the performance of a clinical function, other than that related to basic safety, where loss or degradation beyond limits specified by the manufacturer results in an unacceptable risk.

    What this means in practice

    Defining essential performance correctly is foundational for risk analysis, testing, and labeling under the 60601 family of standards.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    ISO·1IEC·1AAMI·1
    1. 1
      IEC 60601-1
      Verified
      ISOiso.org
    2. 2
      IEC Webstore - Medical Equipment
      Verified
      IECwebstore.iec.ch
    3. 3
      AAMI Standards
      Verified
      AAMIaami.org

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