ABNT Standards Recognised by ANVISA

ABNT (Associação Brasileira de Normas Técnicas) is Brazil's national standards body. ABNT issues technical standards (Normas ABNT NBR) that are adaptations of international standards (ISO, IEC) or original Brazilian standards.

ANVISA recognises ABNT standards as means of demonstrating compliance with the Essential Requirements in RDC 751/2022. Key harmonised ABNT standards for medical devices include:

ABNT Standard	International Equivalent	Topic
ABNT NBR ISO 14971	ISO 14971:2019	Risk management
ABNT NBR ISO 13485	ISO 13485:2016	Quality management systems
ABNT NBR IEC 60601-1	IEC 60601-1	General requirements for electrical medical devices
ABNT NBR IEC 60601-1-2	IEC 60601-1-2	EMC requirements
ABNT NBR IEC 62304	IEC 62304	Software lifecycle
ABNT NBR IEC 62366-1	IEC 62366-1	Usability engineering
ABNT NBR ISO 10993-1	ISO 10993-1	Biocompatibility evaluation
ABNT NBR ISO 11135	ISO 11135	Sterilisation by EtO

• ABNT standards catalogue
• ANVISA harmonised standards list

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Official sources

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