Biocompatibility Testing (ISO 10993)

ANVISA requires biocompatibility evaluation for devices that contact the human body, based on the ISO 10993 series (Brazilian: ABNT NBR ISO 10993).

Key parts: ISO 10993-1 (evaluation within risk management), 10993-5 (cytotoxicity), 10993-10 (sensitisation), 10993-17 (toxicological risk assessment), 10993-18 (chemical characterisation).

Testing must be tailored to nature and duration of contact (surface, external communicating, or implant). Tests may be conducted in INMETRO-accredited laboratories (Brazil) or internationally recognised accreditation bodies (ISO/IEC 17025).

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Official sources

Verify all information against official ANVISA sources before making regulatory decisions.