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CATEGORY: STANDARDS

ISO 10993 (Biocompatibility)

A series of standards for evaluating the biological safety of medical devices. ISO 10993 covers cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation effects, and hemocompatibility testing.

Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy

WHEN IT APPLIES

ISO 10993 is the series of standards for biological evaluation of medical devices, covering cytotoxicity, sensitization, irritation, systemic toxicity, and more.

PROCESS / STEPS

  1. Map device contact category to endpoints.
  2. Perform chemical characterization as appropriate.
  3. Execute or justify biological tests.
  4. Document in biological evaluation report linked to risk management.

EXAMPLES

  • ISO 10993-1 provides the framework; other parts detail specific tests.

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RELATED TERMS

ISO 14971 (Risk Management)