April 3, 2024
ANVISA, through Normative Instruction - IN No. 283 of March 7, 2024, published the update of the applicable standards in the Conformity Assessment for Equipment under the Health Surveillance regime under accreditation General Coordination of Accreditation of Inmetro – Cgcre.
Equipment under the Sanitary Surveillance regime is subject to such assessment and adaptation.
The changes and adjustments include:
|
Item per IN No. 283 |
Description |
Mandatory standard from |
|
General Standard |
||
|
1 |
ABNT NBR IEC 60601-1:2010 + Amendment 1:2016 |
In place |
|
1.1 |
ABNT NBR IEC 60601-1:2010 + Amendment 1:2016 + Amendment 2:2022 |
Dec 31, 2027 |
|
Collateral Standards of Series IEC 60601 |
||
|
1 |
ABNT NBR IEC 60601-1-2:2017 |
In place |
|
1.1 |
ABNT NBR IEC 60601-1-2:2017 + Amendment 1:2022 |
Dec 31, 2027 |
|
2 |
ABNT NBR IEC 60601-1-3:2011 + Amendment 1:2016 |
In place |
|
2.1 |
ABNT NBR IEC 60601-1-3:2016 + Amendment 1:2021 |
Dec 31, 2025 |
|
3 |
ABNT NBR IEC 60601-1-6:2011 + Amendment 1:2020 |
In place |
|
3.1 |
ABNT NBR IEC 60601-1-6:2011 + Amendment 1:2020 + Amendment 2:2022 |
Dec 31, 2025 |
|
4 |
ABNT NBR IEC 60601-1-8:2010 + Amendment 1:2014 |
In place |
|
4.1 |
ABNT NBR IEC 60601-1-8:2010 + Amendment 1:2014 + Amendment 2:2022 |
Dec 31, 2025 |
|
5 |
ABNT NBR IEC 60601-1-9:2010 + Amendment 1:2014 |
In place (1) |
|
5.1 |
ABNT NBR IEC 60601-1-9:2010 + Amendment 1:2014 + Amendment 2:2022 |
Dec 31, 2025 (1) |
|
6 |
ABNT NBR IEC 60601-1-10:2010 + Amendment 1:2017 |
In place |
|
6.1 |
ABNT NBR IEC 60601-1-10:2010 + Amendment 1:2017 + Amendment 2:2022 |
Dec 31, 2025 |
|
7 |
ABNT NBR IEC 60601-1-11:2012 |
In place |
|
7.1 |
ABNT NBR IEC 60601-1-11:2021 |
Dec 31, 2024 |
|
7.2 |
ABNT NBR IEC 60601-1-11:2021 + Amendment 1:2022 |
Dec 31, 2025 |
|
8 |
ABNT NBR IEC 60601-1-12:2020 |
In place |
|
8.1 |
ABNT NBR IEC 60601-1-12:2020 + Amendment 1:2022 |
Dec 31, 2025 |
Note:
(1)Only for clauses 4.1, 4.5.2 e 4.5.3 of referenced standard.
|
Particular Standards of Series IEC 60601/80601 |
||
|
1 |
ABNT NBR IEC 60601-2-2:2022 |
|
|
2 |
ABNT NBR IEC 60601-2-3:2014 + Amendment 1:2019 |
|
|
3 |
ABNT NBR IEC 60601-2-4:2014 |
|
|
3.1 |
ABNT NBR IEC 60601-2-4:2014 + Amendment 1:2022 |
|
|
4 |
ABNT NBR IEC 60601-2-5:2012 |
|
|
5 |
ABNT NBR IEC 60601-2-6:2014 + Amendment 1:2019 |
|
|
6 |
ABNT NBR IEC 60601-2-10:2014 + Amendment 1:2019 |
|
|
7 |
ABNT NBR ISO 80601-2-12:2014 |
|
|
7.1 |
ISO 80601-2-12:2020 |
|
|
8 |
ABNT NBR ISO 80601-2-13:2017 |
|
|
9 |
ABNT NBR IEC 60601-2-16:2015 |
|
|
9.1 |
ABNT NBR IEC 60601-2-16:2022 |
|
|
10 |
ABNT NBR IEC 60601-2-18:2014 |
|
|
11 |
ABNT NBR IEC 60601-2-19:2014 + Amendment 1:2019 |
|
|
11.1 |
ABNT NBR IEC 60601-2-19:2023 |
|
|
12 |
ABNT NBR IEC 60601-2-20:2012 + Amendment 1:2019 |
|
|
12.1 |
ABNT NBR IEC 60601-2-20:2023 |
|
|
13 |
ABNT NBR IEC 60601-2-21:2013 + Amendment 1:2019 |
|
|
13.1 |
ABNT NBR IEC 60601-2-21:2023 |
|
|
14 |
ABNT NBR IEC 60601-2-22:2012 + Amendment 1 :2014 |
|
|
14.1 |
ABNT NBR IEC 60601-2-22:2023 |
|
|
15 |
ABNT NBR IEC 60601-2-23:2012 |
|
|
16 |
ABNT NBR IEC 60601-2-24:2015 |
|
|
17 |
ABNT NBR IEC 60601-2-25:2014 |
|
|
18 |
ABNT NBR IEC 60601-2-26:2014 |
|
|
18.1 |
ABNT NBR IEC 80601-2-26:2021 |
|
|
19 |
ABNT NBR IEC 60601-2-27:2013 |
|
|
20 |
ABNT NBR IEC 60601-2-28:2019 |
|
|
21 |
ABNT NBR IEC 80601-2-30:2012 + Amendment 1:2014 |
|
|
21.1 |
ABNT NBR IEC 80601-2-30:2021 |
|
|
22 |
ABNT NBR IEC 60601-2-31:2013 + Amendment 1:2014 |
|
|
22.1 |
ABNT NBR IEC 60601-2-31:2023 |
|
|
23 |
ABNT NBR IEC 60601-2-34:2014 |
|
|
24 |
ABNT NBR IEC 80601-2-35:2013 + Amendment 1:2019 |
|
|
24.1 |
ABNT NBR IEC 60601-2-35:2023 |
|
|
25 |
ABNT NBR IEC 60601-2-36:2022 |
|
|
26 |
ABNT NBR IEC 60601-2-37:2016 |
|
|
27 |
ABNT NBR IEC 60601-2-39:2010 |
|
|
27.1 |
ABNT NBR IEC 60601-2-39:2021 |
|
|
28 |
ABNT NBR IEC 60601-2-40:2019 |
|
|
29 |
ABNT NBR IEC 60601-2-41:2012 + Amendment 1:2014 |
|
|
30 |
ABNT NBR IEC 60601-2-43:2012 + Amendment 1:2019 + Amendment 2:2021 |
|
|
31 |
ABNT NBR IEC 60601-2-44:2017 |
|
|
32 |
ABNT NBR IEC 60601-2-45:2013 + Amendment 1:2017 |
|
|
33 |
ABNT NBR IEC 60601-2-46:2020 |
|
|
34 |
ABNT NBR IEC 60601-2-47:2014 |
|
|
35 |
ABNT NBR IEC 60601-2-49:2014 |
|
|
35.1 |
ABNT NBR IEC 80601-2-49:2021 |
|
|
36 |
ABNT NBR IEC 60601-2-50:2010 + Amendment 1:2019 |
|
|
36.1 |
ABNT NBR IEC 60601-2-50:2023 |
|
|
37 |
ABNT NBR IEC 60601-2-52:2013 + Amendment 1:2020 |
|
|
38 |
ABNT NBR IEC 60601-2-54:2016 + Amendment 1:2016 + Amendment 2:2020 |
|
|
39 |
ABNT NBR ISO 80601-2-55:2020 |
|
|
40 |
ABNT NBR ISO/IEC 80601-2-56:2013 |
|
|
40.1 |
ABNT NBR ISO 80601-2-56:2021 + Amendment 1:2022 |
|
|
41 |
ABNT NBR IEC 60601-2-57:2015 |
|
|
42 |
ABNT NBR ISO/IEC 80601-2-58:2013 |
|
|
42.1 |
ABNT NBR ISO/IEC 80601-2-58:2017 |
|
|
42.2 |
ABNT NBR ISO/IEC 80601-2-58:2017 + Amendment 1:2021 |
|
|
43 |
ABNT NBR IEC 80601-2-60:2015 |
|
|
43.1 |
ABNT NBR IEC 80601-2-60:2021 |
|
|
44 |
ABNT NBR ISO 80601-2-61:2015 |
|
|
44.1 |
ABNT NBR ISO 80601-2-61:2022 |
|
|
45 |
ABNT NBR IEC 60601-2-62:2015 |
|
|
46 |
ABNT NBR IEC 60601-2-63:2015 + Amendment 1:2020 |
|
|
46.1 |
ABNT NBR IEC 60601-2-63:2015 + Amendment 1:2020 + Amendment 2:2023 |
|
|
47 |
ABNT NBR IEC 60601-2-65:2014 + Amendment 1:2020 |
|
|
48 |
ABNT NBR IEC 60601-2-66:2020 |
|
|
49 |
ABNT NBR ISO 80601-2-70:2017 |
|
|
49.1 |
ABNT NBR ISO 80601-2-70:2022 |
|
|
50 |
ABNT NBR ISO 80601-2-72:2018 |
|
|
51 |
ABNT NBR ISO 80601-2-74:2020 |
|
|
52 |
ABNT NBR IEC 60601-2-75:2022 |
|
|
53 |
ABNT NBR ISO 80601-2-79:2020 |
|
|
54 |
ABNT NBR ISO 80601-2-80:2020 |
|
|
55 |
ABNT NBR IEC 60601-2-83:2022 |
|
|
56 |
ISO 80601-2-84:2020 |
|
|
Other Standards |
||
|
1 |
ISO 14457:2017 |
|
|
2 |
ISO 7494-1:2018 |
|
|
3 |
ISO 7494-2:2015 |
|
|
3.1 |
ISO 7494-2:2022 |
|
|
4 |
ISO 9680:2014 |
|
|
4.1 |
ISO 9680:2021 |
|
|
5 |
ABNT NBR ISO 11195: 2021 |
|
|
6 |
ABNT NBR ISO 7176-1:2018 |
|
|
7 |
ABNT NBR ISO 7176-3:2015 |
|
|
8 |
ABNT NBR ISO 7176-5:2015 |
|
|
9 |
ABNT NBR ISO 7176-6:2019 |
|
|
10 |
ABNT NBR ISO 7176-7:2009 |
|
|
11 |
ABNT NBR ISO 7176-8:2009 |
|
|
11.1 |
ABNT NBR ISO 7176-8:2018 |
|
|
12 |
ABNT NBR ISO 7176-10:2015 |
|
|
13 |
ISO 7176-14:2008 |
|
|
14 |
ABNT NBR ISO 7176-15:2009 |
|
|
15 |
ABNT NBR ISO 7176-21:2019 |
|
|
16 |
ISO 7176-25:2013 |
|
|
17 |
ISO 7176-31:2023 |
|
|
18 |
ISO 10535:2006 |
|
|
19 |
ISO 10079-1:2022 |
|
|
20 |
ISO 10079-4:2021 |
|
|
21 |
ISO 17966: 2016 |
|
Deadline for carrying out the program
The requirements came into effect per table the above.
How to adapt your products
UL offers a complete solution for all manufacturers, importers, and suppliers to comply with the program, in addition to providing all the necessary support for the applicant to obtain certification with INMETRO.
Click here to read full Normative Instruction no. 283/2024 (Portuguese only).
Get connected with our sales team
Thanks for your interest in UL's products and services. Let's collect some information so we can connect you with the right person.