Upcoming Technical Standards from ANVISA
According to ANVISA IN 116/2021, 15 technical standards will come into force on December 31st, 2023. Furthermore, all products certified in accordance with INMETRO Ordinance 384 of December 18th, 2020, based on these technical standards, will need to undergo test review and update.
We suggest contacting ORBIS to begin the process of adapting your certificate to these new technical standards. Our goal is to keep you a step ahead and empower your team. To avoid complications from these regulatory adjustments, be sure to contact ORBIS as soon as possible to ensure your certificate remains valid and complies with the updated regulations.
Summary of Standards
| Nro | National Version | International Version |
|---|---|---|
| 1 | ISO 80601-2-12:2020 | ISO 80601-2-12-2020 |
| 2 | ABNT IEC 80601-2-35:2013 + Emenda 1:2019 | ISO 80601-2-35-2009 + And 1: 2016 |
| 3 | ABNT IEC 80601-2-43:2012 + Emenda 1:2019 + Entenda 2:2021 | ISO 60601-2-43-2010 + And 1: 2017 + AMD 2:2019 |
| 4 | ABNT IEC 80601-2-46:2020 | ISO 60601-2-46:2016 |
| 5 | ABNT IEC 80601-2-55:2020 | ISO 80601-2-55:2018 |
| 6 | ABNT IEC 80601-2-66:2020 | ISO 60601-2-66:2019 |
| 7 | ABNT IEC 80601-2-70:2017 | ISO 80601-2-70:2015 |
| 8 | ABNT IEC 80601-2-72:2018 | ISO 80601-2-72:2015 |
| 9 | ABNT IEC 80601-2-74:2020 | ISO 80601-2-74:2017 |
| 10 | ISO 80601-2-84:2020 | ISO 80601-2-84:2020 |
| 11 | ISO 14457:2017 | ISO 14457:2017 |
| 12 | ISO 7494-1:2018 | ISO 7494-1:2018 |
| 13 | ABNT NBR ISO 11195:2011 | ISO 11195:2018 |