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    ISO 10993-1

    Biological evaluation of medical devices within a risk management process.

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

    Definition

    ISO 10993-1:2018 describes the general principles governing the biological evaluation of medical devices within a risk management process, including selection of evaluation tests based on tissue contact and duration.

    What this means in practice

    Biocompatibility documentation is a routine requirement for any patient-contacting device. FDA's recognized version aligns with ISO 10993-1:2018 plus FDA-specific guidance.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    ISO·2IEC·1
    1. 1
      ISO 10993-1:2018
      Verified
      ISOiso.org
    2. 2
      ISO Standards Catalogue - Health
      Verified
      ISOiso.org
    3. 3
      IEC Webstore - Medical Equipment
      Verified
      IECwebstore.iec.ch

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