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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 the regulation says
    ISO 10993-1:2018 outlines a structured approach to biological evaluation as part of a risk management process, emphasizing that biocompatibility assessment should consider the nature and duration of device contact with the body. The FDA recognizes ISO 10993-1:2018, often supplementing it with specific FDA guidance documents, such as the "Use of International Standard ISO 10993-1,

    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.

    Examples

    • A manufacturer of an implantable bone screw uses ISO 10993-1 to determine the necessary biological tests, including cytotoxicity, sensitization, and implantation studies, based on its permanent tissue contact.
    • For a single-use external bandage, a company applies the principles of ISO 10993-1 to justify conducting only cytotoxicity and skin irritation tests, considering its limited skin contact duration.
    • When redesigning a catheter with a new coating, a company refers to ISO 10993-1 to reassess biocompatibility implications and identifies the need for additional material characterization and systemic toxicity tests.
    Common pitfalls
    • •Failing to integrate biocompatibility evaluation into the overall risk management process can lead to overlooked hazards.
    • •Selecting inappropriate test methods based on incorrect assumptions about device contact or duration can result in inadequate biological evaluation.
    • •Not considering the manufacturing process and its potential impact on the device's biocompatibility can lead to non-conformance.
    • •Ignoring changes in device materials or intended use can invalidate previous biocompatibility assessments.
    • •Solely relying on material certificates without conducting device-specific testing when necessary is a common pitfall.

    Frequently asked questions

    The primary purpose is to establish general principles for the biological evaluation of MedTech devices, ensuring their safety regarding interaction with biological systems. It guides the selection of appropriate tests based on risk assessment.
    Grouped by theme

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    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.