Dear Clients,
We hereby inform and advise our clients on the Normative Instruction Normative Instruction – IN No. 283, dated March 7, 2024, which establishes the criteria for the applicability of technical standards for Inmetro certification, in accordance with Inmetro Ordinance No. 384, for the scope of electromedical equipment under health surveillance.
According to this Normative Instruction, failure to update standards within the established deadlines may directly impact the maintenance of certification, especially in situations involving requests to the regulatory authority, such as:
- Granting of registration or notification;
- Revalidation;
- Technical or registration changes to the product.
Given this scenario, we emphasize the importance for holders of Inmetro certificates to begin the standard update process as soon as possible, in order to avoid unforeseen issues that could compromise certification compliance and product commercialization in the market.
Standards applicable as of 12/31/2025:
- ABNT NBR IEC 60601-1-3:2016 + Amendment 1:2021
- ABNT NBR IEC 60601-1-6:2011 + Amendment 1:2020 + Amendment 2:2022
- ABNT NBR IEC 60601-1-8:2010 + Amendment 1:2014 + Amendment 2:2022
- ABNT NBR IEC 60601-1-9:2010 + Amendment 1:2014 + Amendment 2:2022
- ABNT NBR IEC 60601-1-10:2010 + Amendment 1:2017 + Amendment 2:2022
- ABNT NBR IEC 60601-1-11:2021 + Amendment 1:2022
- ABNT NBR IEC 60601-1-12:2020 + Amendment 1:2022
- ABNT NBR IEC 60601-2-4:2014 + Amendment 1:2022
- ABNT NBR IEC 60601-2-63:2015 + Amendment 1:2020 + Amendment 2:2023
Important: The standards ABNT NBR IEC 60601-1-6 and ABNT NBR IEC 60601-1-9 are documentary in nature, and compliance can be assessed through document analysis without the need for laboratory testing. Our engineering team is available to guide and support you throughout this process.
Considering the importance and relevance of this matter, we prepared a special approach for your company:
Please reply to this email informing the Inmetro certificate numbers under your responsibility, so we can assess your specific scenario and propose a customized solution aligned with current regulatory requirements.
Count on us to to provide technical, transparent, and secure support, ensuring the continuity and robustness of your certification process.