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Federal Public Service


MINISTRY OF ECONOMY
NATIONAL INSTITUTE OF METROLOGY, QUALITY AND TECHNOLOGY-INMETRO

ORDINANCE No. 115, OF MARCH 21, 2022

Approves Conformity Assessment Requirements


for Electrical Equipment for Explosive Atmospheres –
Consolidated.

THE PRESIDENT OF THE NATIONAL INSTITUTE OF METROLOGY, QUALITY AND TECHNOLOGY - INMETRO,
in the exercise of the competence granted to it by articles 4, § 2, of Law No. 5,966, of 11
December 1973, and 3rd, items I and IV, of Law No. 9,933, of December 20, 1999, combined with the
provided for in articles 18, item V, of Annex I to Decree No. 6,275, of November 28, 2007, and 105,
item V, of the Annex to Ordinance No. 2, of January 4, 2017, of the then Ministry of Industry, Commerce
Exterior and Services, considering what determines Decree No. 10,139, of November 28, 2019, and the
which appears in SEI Process No. 0052600.007363/2021-43, resolves:

Object and scope of application

Art. 1 The Consolidated Regulation for Electrical Equipment for Explosive Atmospheres is hereby approved,
in the form of the Conformity Assessment Requirements and Specifications for the Safety Seal.
Identification of Compliance, set out, respectively, in Annexes I and II of this Ordinance.

Art. 2 Suppliers of electrical equipment for explosive atmospheres must comply with
fully comply with the provisions of this Regulation.

Art. 3 Electrical equipment for explosive atmospheres, objects of this Regulation, must
be manufactured, imported, distributed and marketed in a way that does not pose risks that
compromise user safety, regardless of full compliance with current requirements
published.

§ 1 This Regulation applies to:

I – electrical equipment for explosive atmospheres, in gas and vapor conditions


flammable, in environments classified as zone 0, zone 1 or zone 2;

II – electrical equipment for explosive atmospheres, in combustible dust conditions, in environments


classified as zone 20, zone 21 or zone 22;

III – electromechanical equipment with its own pumping, with or without a reservoir,
intended for filtering diesel oil (filter presses for diesel oil); It is

IV – instruments designed to continuously measure the volumes of liquid fuels.

§ 2 The following are excluded from complying with the provisions set out in this Regulation:

I – electrical equipment for explosive atmospheres, in conditions of flammable gases and vapors, acquired
abroad and installed in maritime units intended for off shore work
for research, drilling and production of oil or transportation of flammable products, during the manufacture of the
marine unit in a foreign shipyard, including spare parts supplied together with the marine unit, since the suppliers'
acceptance criteria will be valid for these purposes
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and certifications adopted by naval classification societies, upon entry or beginning of operations in Brazilian
territorial waters;

II – electrical equipment intended for application in industrial environments not subject to explosive
atmospheres or not subject to technical recommendations for the application of electrical equipment for explosive
atmospheres;

III – electrical equipment not intended for use in explosive atmospheres that can be installed in environments
with explosive atmospheres classified as a zone 2 area for flammable gases and vapors or as a zone 22 area for
combustible dust; It is

III - electrical equipment not intended for use in explosive atmospheres that can be installed in environments
with explosive atmospheres classified as a zone 2 area for flammable gases and vapors or as a zone 22 area for
combustible dust, which have been designed and constructed in accordance with the respective industrial standards
applicable, and that in normal operation:

a) do not have hot surfaces capable of igniting an explosive atmosphere;

b) do not produce arcs or sparks; It is

c) are mounted in an enclosure that has a degree of protection and mechanical resistance
suitable for a non-classified area with equivalent environmental conditions;

Rectification published in the DOU of August 30, 2022.

IV – repair, review and recovery services for electrical equipment for explosive atmospheres, in conditions of flammable gases and
vapors and combustible dust, in accordance with ABNT NBR IEC 60079-19.

Art. 4 The production chain of electrical equipment for explosive atmospheres is subject to the
following obligations and responsibilities:

I – the national manufacturer must manufacture and make available, free of charge or for a fee, electrical
equipment for explosive atmospheres, in accordance with the provisions of this Regulation;

II – the importer must import and make available, free of charge or for a fee, electrical equipment
for explosive atmospheres, in accordance with the provisions of this Regulation; It is

III – other entities in the production and supply chain of electrical equipment for explosive atmospheres,
including commerce in physical or virtual establishments, must maintain the
integrity of the product, its mandatory markings, preserving compliance with the requirements
of this Regulation.

Single paragraph. If an entity performs more than one function in the production and supply chain,
Among those previously listed, your responsibilities are accumulated.

Pre-Market Requirements

Art. 5 Electrical equipment for explosive atmospheres manufactured, imported, distributed


and sold in the national territory, free of charge or for payment, must be submitted,
compulsorily, conformity assessment, through the certification mechanism, observing the
terms of this Regulation.

§ 1 Conformity Assessment Requirements for Electrical Equipment for Atmospheres


Explosives, are set out in Annex I.

§ 2 Certification does not exempt the supplier from exclusive responsibility for the safety of the product.
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§ 3 Obtaining certification is a condition for authorizing the use of the Identification Seal
of Conformity in certified products and for their availability on the national market.

§ 4 The Conformity Identification Seal model applicable to electrical equipment for


explosive atmospheres, is found in Annex II.

Market Surveillance

Art. 6 Electrical equipment for explosive atmospheres, objects of this Regulation, are
subject, throughout the national territory, to market surveillance actions carried out by Inmetro and
public law entities linked to it by delegation agreement.

Art. 7º An action or omission contrary to the provisions of this Ordinance constitutes an infraction, which may give rise to
the penalties provided for in Law No. 9,933, of 1999.

Art. 8º It is up to the supplier, when subjected to market surveillance actions, to provide the
Inmetro, when requested, the required information within a maximum period of 15 days.

Deadlines and transitional provisions

Art. 9 The publication of this Ordinance does not imply the need for a new process to be initiated
certification based on the requirements now consolidated.

Single paragraph. The certificates issued must be reviewed, for reference to the Ordinance now published, in the next stage
of evaluation.

Art. 10. Certificates issued based on Inmetro Ordinance No. 179, of May 18, 2010, must have their validity adjusted, in
accordance with subitem 6.1.1.6 of the RAC, established in Annex I of this Ordinance, having as reference the date grant.

Art. 10. Certificates issued based on Inmetro Ordinance No. 179, of May 18, 2010, must have their validity adjusted, in
accordance with subitem 6.1.1.6 of the RAC, established in Annex I of this Ordinance, having as reference the date grant.

§ 1 Exclusively for the purposes of dismembering certificates issued based on Inmetro Ordinance nº 179, of 2010, aiming to
comply with the definition of family provided for in subitem 4.2
of Annex I of this Ordinance, test reports issued before the start of the certification process may be accepted, by laboratories
accredited by Inmetro or signatory of the ILAC or IAAC mutual recognition agreements or by laboratories approved by IECEx,
provided that these reports are part of the process of certification of the family that gave rise to the break-up.

§ 2 The dismemberment referred to in the caput must be carried out within a maximum period of 12 (twelve)
months, counting from the effective date of this Ordinance.

§ 2 The dismemberment referred to in the caput must be carried out within a maximum period of 60 (sixty)
months, counting from the effective date of this Ordinance."

Rectification published in the DOU of 12/1/2023

Art.10A. Certificates issued based on subitem 4.18 of the RAC attached to Inmetro Ordinance No. 179, of May 18, 2010,
must be adapted to the provisions of Annex I within 24 (twenty-four) months from the effective date of the Ordinance now approved.

Rectification published in the DOU of August 30, 2022.

Art. 11. From the effective date of this Ordinance, manufacturers and importers must adopt, in new certification processes
for electrical equipment for explosive atmospheres, the conditions and layout of the Conformity Identification Seal as per Annex II
of this Ordinance.

Art. 12. Families of electrical equipment for explosive atmospheres, already certified to date
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of validity of this Ordinance, must adopt within 60 (sixty) months, counting from the effective date of this Ordinance,
the Conformity Identification Seal, affixed to the product, according to the conditions and layout
applicable Conformity Identification Seal as per Annex II of this Ordinance.

Single paragraph. Manufacturers and importers of families of electrical equipment for explosive atmospheres,
already certified, have up to 36 (thirty-six) months, counting from the effective date of this Ordinance, to adapt the
certification processes in order to meet, on the packaging, the conditions and the applicable layout of the Conformity
Identification Seal as per Annex II of this Ordinance.

Revocation clause

Art. 13. On the effective date of this Ordinance, the Inmetro Ordinances are hereby revoked:

I – nº 179, of May 18, 2010, published in the Official Gazette of the Union of May 20, 2010, section
1, page 76; It is

II – nº 89, of February 23, 2012, published in the Official Gazette of the Union of February 27,
2012, section 1, page 151.

Validity

Art. 14. This Ordinance comes into force on April 1, 2022, as determined by art. 4th of Decree No. 10,139, of
2019.

MARCOS HELENO GUERSON DE OLIVEIRA JÚNIOR

President
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ANNEX TO INMETRO ORDINANCE No. 115/2022

ANNEX I – CONFORMITY ASSESSMENT REQUIREMENTS FOR


ELECTRICAL EQUIPMENT FOR EXPLOSIVE ATMOSPHERES

1. OBJECTIVE

Establish criteria and procedures for evaluating the conformity of electrical equipment for explosive atmospheres, with a
focus on safety, through the certification mechanism, aiming to provide greater safety for workers, facilities and the
environment.

1.1 GROUPING FOR CERTIFICATION PURPOSES

For certification of the object, the concept of family is applicable, as per subsection 4.2.

2. ACRONYMS

For the purposes of these RAC, the following acronyms are adopted, complemented by the acronyms contained in the
complementary documents mentioned in item 3 of this RAC:

ATEX Explosive Atmosphere

AND THE
European Cooperation for Accreditation

ExCB IECEx Certification Bodies

ExTL IECEx approved Testing Laboratories

ExTR IECEx Test Reports

International Electrotechnical Commission Scheme for Certification to Standards


IECEx
Relating to Equipment for use in Explosive Atmospheres (IECEx Scheme)

PQAN Product Quality Assurance Notification

QAR Quality Audit Report

For the purposes of these RAC, the following acronyms are adopted, complemented by the acronyms contained in the
complementary documents mentioned in item 3 of this RAC:

ExCB IECEx Certification Bodies

ExTL IECEx approved Testing Laboratories

ExTR IECEx Test Reports

International Electrotechnical Commission Scheme for Certification to Standards


IECEx
Relating to Equipment for use in Explosive Atmospheres (IECEx Scheme)

QAR Quality Audit Report

Rectification published in the DOU of August 30, 2022.

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ANNEX TO INMETRO ORDINANCE No. 115/2022

3. DOCUMENTS

3.1 For the purposes of this RAC, the following documents are adopted, in addition to those mentioned in the RGCP:

Storage of flammable and combustible liquids —


ABNT NBR 14639:2014 Vehicle dealer station (services) and refueling point —
Electrical installations.

Storage of flammable and combustible liquids ÿ


ABNT NBR 15456:2016
Construction and testing of supply unit

Rotating electrical machines – Part 5: Degrees of protection provided


ABNT NBR IEC 60034-5:2009 by the complete design of rotating electrical machines (IP Codes) –
Classification.

International electrotechnical vocabulary – Part 426:


ABNT NBR IEC 60050-426:2011
Equipment for explosive atmospheres.

Explosive atmospheres – Part 0: Equipment – General requirements.


ABNT NBR IEC 60079-0:2020

Explosive atmospheres – Part 1: Protection of equipment by explosion-


ABNT NBR IEC 60079-1:2016
proof enclosure “d”.

Explosive atmospheres – Part 2: Protection of equipment by pressurized


ABNT NBR IEC 60079-2:2016
enclosure “p”.

Explosive atmospheres – Part 5: Protection of equipment by immersion in


ABNT NBR IEC 60079-5:2016
“q” sand.

Explosive atmospheres – Part 6: Protection of equipment by immersion


ABNT NBR IEC 60079-6:2017
in liquid “o”.

Explosive atmospheres – Part 7: Protection of equipment by increased


ABNT NBR IEC 60079-7:2018
safety “e”.

Explosive atmospheres – Part 10-1: Classification of areas –


ABNT NBR IEC 60079-10-1:2018
Explosive gas atmospheres.

Explosive atmospheres – Part 10-2: Classification of areas –


ABNT NBR IEC 60079-10-2:2016
Explosive dust atmospheres.

Explosive atmospheres – Part 11: Protection of equipment by intrinsic


ABNT NBR IEC 60079-11:2013
safety “i”.

Explosive atmospheres – Part 13: Protection of equipment by pressurized


ABNT NBR IEC 60079-13:2019 environment “p” and by artificially ventilated environment “v”.

Explosive atmospheres – Part 14: Design, selection and


ABNT NBR IEC 60079-14:2016
assembly of electrical installations.

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ANNEX TO INMETRO ORDINANCE No. 115/2022

Explosive atmospheres – Part 15: Protection of equipment by type of


ABNT NBR IEC 60079-15:2019
protection “n”.

Electrical equipment for explosive atmospheres –


ABNT NBR IEC/TR 60079-16:2009 Part 16: Electrical equipment for explosive atmospheres – Artificial ventilation
to protect analyzer houses.

Explosive atmospheres – Part 17: Inspection and maintenance of electrical


ABNT NBR IEC 60079-17:2014
installations.

Explosive atmospheres – Part 18: Equipment protection by “m” encapsulation.


ABNT NBR IEC 60079-18:2016

Explosive atmospheres – Part 19: Repair, review and recovery of


ABNT NBR IEC 60079-19:2020
equipment.

Explosive atmospheres – Part 25: Intrinsically safe electrical


ABNT NBR IEC 60079-25:2011
systems.

Explosive atmospheres – Part 26: Equipment with equipment protection level


ABNT NBR IEC 60079-26:2016
(EPL) Ga.

Explosive atmospheres – Part 28: Protection of equipment and transmission


ABNT NBR IEC 60079-28:2016
systems that use optical radiation.

Explosive atmospheres – Part 29-1: Gas detectors –


ABNT NBR IEC 60079-29-1:2008 Performance requirements for detectors for flammable gases.

Explosive atmospheres – Part 29-2: Gas detectors -


ABNT NBR IEC 60079-29-2:2011 Selection, installation, use and maintenance of detectors for flammable
gases and oxygen.

Explosive atmospheres – Part 31: Protection of equipment against dust


ABNT NBR IEC 60079-31:2014
ignition by “t” casing.

Explosive atmospheres – Part 34: Application of quality management


ABNT NBR IEC 60079-34:2020
systems for the manufacture of “Ex” products

Explosive atmospheres – Part 35-1: Helmet lamps for use in mines subject to
ABNT NBR IEC 60079-35-1:2013 firedamp – General requirements
— Construction and testing in relation to explosion risk

Explosive atmospheres – Part 35-2: Helmet lamps for use in mines subject to
ABNT NBR IEC 60079-35-2:2013 firedamp – Performance and other safety-related requirements

ABNT NBR IEC 60529:2017 Degrees of protection provided by enclosures (IP Code).

Explosive atmospheres – Part 20-1: Characteristics of substances


ABNT NBR IEC 80079-20-1:2020 for classifying gases and vapors – Test methods and data.

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ANNEX TO INMETRO ORDINANCE No. 115/2022

Explosive atmospheres – Part 20-2: Material characteristics –


ABNT NBR IEC 80079-20-2:2018
Combustible dust test methods.

Explosive atmospheres - Part 30-1: Electrical resistance trace heating


IEC/IEEE 60079-30-1:2015
- General and testing requirements

Explosive atmospheres – Part 30-2: Electrical resistance trace heating –


IEC/IEEE 60079-30-2:2015 Application guide for design, installation and maintenance

Sintered metal materials, excluding hardmetals —


ISO 2738:1999 Permeable sintered metal materials — Determination of
density, oil content and open porosity

Permeable sintered metal materials — Determination of


ISO 4003:1977
bubble test pore size

Inmetro Ordinance nº 200, of 2021. Approves the General Product Certification Requirements – RGCP.

MTE Ordinance No. 598, of 2004 - NR-10,


Safety in Electrical Installation and Services.
or substitute.

3.1 For the purposes of this RAC, the following documents are adopted, in addition to those mentioned in the RGCP:

ABNT NBR 14639:2014 Storage of flammable and combustible liquids —


Vehicle dealer station (services) and refueling point — Electrical installations.

ABNT NBR 15456:2016 Storage of flammable and combustible liquids ÿ


Construction and testing of supply unit.

ABNT NBR IEC 60034-5:2009 Rotating electrical machines – Part 5: Degrees of protection provided by the
complete design of rotating electrical machines (IP Codes) – Classification.

ABNT NBR IEC 60050-426:2022 International electrotechnical vocabulary - Part 426: Explosive atmospheres.

ABNT NBR IEC 60079-0:2020 Explosive atmospheres – Part 0: Equipment – General requirements.

ABNT NBR IEC 60079-1:2016 Version Explosive atmospheres – Part 1: Protection of equipment by explosion-proof
Corrected: 2020 enclosure “d”.

ABNT NBR IEC 60079-2:2016 Explosive atmospheres – Part 2: Protection of equipment by pressurized
enclosure “p”.

ABNT NBR IEC 60079-5:2016 Explosive atmospheres – Part 5: Protection of equipment by immersion in “q”
sand.

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ANNEX TO INMETRO ORDINANCE No. 115/2022

ABNT NBR IEC 60079-6:2021 Explosive atmospheres – Part 6: Protection of equipment by immersion in
liquid “o”.

ABNT NBR IEC 60079-7:2018 Version Explosive atmospheres – Part 7: Protection of equipment by increased safety
Corrected:2022 “e”.

ABNT NBR IEC 60079-10-1:2018 Explosive atmospheres – Part 10-1: Classification of areas –
Corrected Version:2019 Explosive gas atmospheres.

ABNT NBR IEC 60079-10-2:2016 Explosive atmospheres – Part 10-2: Classification of areas –
Explosive dust atmospheres.

ABNT NBR IEC 60079-11:2013 Version Explosive atmospheres – Part 11: Protection of equipment by intrinsic safety
Corrected:2017 “i”.

ABNT NBR IEC 60079-13:2019 Explosive atmospheres – Part 13: Protection of equipment by pressurized
environment “p” and by artificially ventilated environment “v”.

ABNT NBR IEC 60079-14:2016 and Explosive atmospheres – Part 14: Design, selection and assembly of
Errata 1 of 2018 electrical installations.

ABNT NBR IEC 60079-15:2019 Explosive atmospheres – Part 15: Protection of equipment by type of
protection “n”.

ABNT NBR IEC/TR 60079-16:2009 Electrical equipment for explosive atmospheres – Part 16: Artificial ventilation
to protect analyzer houses.
ABNT NBR IEC 60079-17:2014 Version Explosive atmospheres – Part 17: Inspection and maintenance of electrical
Corrected:2017 installations.

ABNT NBR IEC 60079-18:2020 Explosive atmospheres – Part 18: Equipment protection by “m” encapsulation.

ABNT NBR IEC 60079-19:2020 Explosive atmospheres – Part 19: Repair, review and recovery of equipment.

ABNT NBR IEC 60079-25:2021 Explosive atmospheres – Part 25: Intrinsically safe electrical systems.

ABNT NBR IEC 60079-26:2016 Explosive atmospheres – Part 26: Equipment with equipment protection level
(EPL) Ga.

ABNT NBR IEC 60079-28:2016 Version Explosive atmospheres – Part 28: Protection of equipment and transmission
Corrected:2021 systems that use optical radiation.

ABNT NBR IEC 60079-29-1:2008 Explosive atmospheres – Part 29-1: Gas detectors –
Performance requirements for detectors for flammable gases.

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ABNT NBR IEC 60079-29-2:2011 Explosive atmospheres – Part 29-2: Gas detectors -
Selection, installation, use and maintenance of detectors for
flammable gases and oxygen.

ABNT NBR IEC 60079-31:2014 Version Explosive atmospheres – Part 31: Protection of equipment against
Corrected:2021 dust ignition by “t” casing.

ABNT NBR IEC 60079-35-1:2013 Explosive atmospheres – Part 35-1: Helmet lights for use in mines
subject to firedamp — General requirements —
Construction and testing in relation to explosion risk.

ABNT NBR IEC 60079-35-2:2013 Explosive atmospheres – Part 35-2: Helmet lights for use in mines
subject to firedamp – Performance and other safety-related
requirements.

ABNT NBR IEC 60529:2017 Degrees of protection provided by enclosures (IP Codes).

ABNT NBR ISO/IEC 80079-20-1:2020 Explosive atmospheres – Part 20-1: Characteristics of substances for classifying gases and
vapors – Test methods and data.

ABNT NBR ISO/IEC 80079-20-2:2018 Explosive atmospheres – Part 20-2: Characteristics of


materials – Combustible dust test methods.

ABNT NBR ISO/IEC 80079-34:2020 Explosive atmospheres – Part 34: Application of quality management
systems for the manufacture of “Ex” products.

IEC/IEEE 60079-30-1:2015 Explosive atmospheres - Part 30-1: Electrical resistance trace


heating - General and testing requirements.

IEC/IEEE 60079-30-2:2015 Explosive atmospheres – Part 30-2: Electrical resistance trace heating –
Application guide for design, installation and maintenance.

Inmetro Ordinance nº 200, of 2021. Approves the General Product Certification Requirements – RGCP.

MTE Ordinance No. 598, of 2004 - Safety in Electrical Installation and Services.
NR-10, or substitute.

Note: Errata and corrected versions of the versions of the standards referenced above, which may be published
after this RAC, must be considered.

Rectification published in the DOU of August 30, 2022.

3.2 Equipment manufactured in compliance with the latest version of the IEC Standard available must be certified
in compliance with this RAC and its deviations validated by the OCP.

3.3 Measuring Pumps product certification must only be conducted with ABNT NBR 15456:2016.

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ANNEX TO INMETRO ORDINANCE No. 115/2022

4 DEFINITIONS

For the purposes of this RAC, the following definitions are adopted, complemented by the definitions contained in the documents
mentioned in item 3 of this RAC.

4.1 Electrical equipment for explosive atmospheres

Modular process unit (SKID), equipment, component, accessory, fixed, personal, portable or transportable, of
the type: electrical, electronic, instrumentation or telecommunications, which incorporates a set of specific
measures to prevent the ignition of an explosive atmosphere at its around, used as part of, or in connection with
an installation, or operated, in an area subject to an explosive atmosphere.

4.2 Product family

Grouping of product models from the same manufacturer and the same manufacturing unit, from the same
production process, with similar designs and functionalities, in addition to construction characteristics and a set
of specific protection measures to prevent the ignition of a surrounding explosive atmosphere, meeting the same
requirements .
4.3 Series

Vendor-defined designation that identifies the model version.


4.4 Classification societies

Private and independent entities that provide classification, certification and assistance services to the maritime
sector and regulatory bodies with regard to maritime safety, safeguarding human life at sea and preventing
pollution. They are recognized as entities authorized to issue statutory certificates on behalf of maritime flag
States, hence they are also designated as Recognized Organizations.

4.5 Modular process unit – Skid Mounted

Unit consisting of a set of equipment, components and accessories pre-assembled on a chassis and pre-tested
in the factory, which will be assembled, interconnected and tested at the destination, completing the function of
its respective industrial system.

5 CONFORMITY ASSESSMENT MECHANISM

The conformity assessment mechanism for electrical equipment for explosive atmospheres is certification.

6 STEPS OF CONFORMITY ASSESSMENT

The conformity assessment process consists of several steps, as defined in the RGCP.
Each stage follows a sequence of procedures, according to the Certification Model adopted.

This RAC establishes the following certification model options:

a) Certification Model 5 – Initial assessment consisting of tests on samples taken from the manufacturer,
including audit of the Quality Management System - SGQ, followed by periodic maintenance assessment
through collection of product samples at the factory, to carry out maintenance activities conformity
assessment and QMS audit;

b) Certification Model 1b – Batch test; It is

c) Status Certification Model for Imported Product (SPI) – Assessment consisting of inspection
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ANNEX TO INMETRO ORDINANCE No. 115/2022

of a batch of products. The inspection aims to verify whether the imported items correspond to the documentation
presented. The Certificate of Conformity is restricted to the certified batch. In this model, there is no periodic
maintenance assessment.

6.1 Certification Model 5

6.1.1 Initial Assessment

6.1.1.1 Certification Request

The supplier must forward a formal request to the OCP, providing the documentation described in the RGCP.

6.1.1.2 Analysis of Request and Documentation Compliance

The criteria for analyzing the request and document compliance must follow the requirements described in the RGCP.

6.1.1.3 Initial Audit of the Quality Management System and Assessment of the Production Process

6.1.1.3.1 The initial audit criteria of the quality management system and evaluation of the production process must
follow the requirements established in the RGCP, modified by the specific requirements below.

6.1.1.3.2 The assessment of the QMS must be carried out by the OCP based on the scope of the certification process
and in accordance with the requirements of the ISO 9001:2015 standard or the ABNT NBR ISO 9001:2015 standard,
with the minimum requirements being those defined in Table 1 below and those included in Annex A.

Table 1 - Minimum QMS verification requirements for manufacturers without certification to the standard
ISO 9001 or ABNT NBR ISO 9001 standard.

Actions to address risks and opportunities 6.1

Monitoring and measurement capabilities 7.1.5

Documented information 7.5.2 / 7.5.3

Operational planning and control 8.1

Control of processes, products and services provided externally 8.4.2 / 8.4.3

Production and service provision 8.5.1 / 8.5.2 / 8.5.4 / 8.5.5

Release of products and services 8.6

Control of non-conforming outputs 8.7

Monitoring, measurement, analysis and evaluation 9.1.1 / 9.1.2

Improvement 10.2 / 10.3

6.1.1.3.3 The presentation of a certificate from the manufacturer's QMS, within its validity, which is issued by an OCS
accredited by Inmetro or a member of the IAF MLA, according to ISO 9001 or ABNT NBR ISO 9001 and this
certification is valid for the production line of the product subject to certification, it may exempt the requesting
company, under the analysis and responsibility of the OCP, from the QMS assessment provided for in this RAC,
during the initial audit. In this case, the requesting company must make available to the OCP

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ANNEX TO INMETRO ORDINANCE No. 115/2022

all records corresponding to this certification. The OCP must review the relevant documentation to ensure that the requirements
described in Table 1 have been met.

6.1.1.3.3.1 Even upon presentation of a valid certificate, under the conditions set out above, the OCP
must carry out an audit of the QMS at the manufacturing unit with the aim of verifying the conformity of the production process to that
established in Annex A of this RAC.

6.1.1.4 Initial Test Plan

The initial test plan criteria must follow the requirements established in the RGCP.

6.1.1.4.1 Definition of the Tests to be carried out

6.1.1.4.1.1 The criteria for defining tests must follow the requirements established in the RGCP.

6.1.1.4.1.2 Type tests must be carried out in accordance with the relevant requirements of the standards
applicable items listed in item 3 of this RAC, as per subitem 6.1.1.4.2.

6.1.1.4.1 Definition of the Tests to be carried out

6.1.1.4.1.1 The criteria for defining tests must follow the requirements established in the RGCP.

6.1.1.4.1.2 Type tests must be carried out in accordance with the relevant requirements of the applicable standards listed in item 3
of this RAC, as per subitem 6.1.1.4.2.

6.1.1.4.1.3 Test reports issued up to 2 (two) years before the beginning of the certification process, carried out by foreign laboratories,
may be accepted, provided that the equivalences of the established test method and sampling methodology are observed, and the
said laboratories are accredited by Inmetro or by an Accreditation Body that is a signatory to ILAC or IAAC mutual recognition
agreements.

Rectification published in the DOU of August 30, 2022.

6.1.1.4.2 Sampling Definition

6.1.1.4.2.1 The sampling definition criteria must follow the requirements established in the RGCP.

6.1.1.4.2.2 Samples (proof, counter-test and witness) must be collected in the quantity necessary to carry out the tests provided for
in subitem 6.1.1.4.1.

6.1.1.4.2.3 Samples must be collected from 1 (one) model in the family, and the one with the largest number of components to be
tested must be selected.

6.1.1.4.2.3 Samples must be collected from at least 1 (one) model in the family, and the most critical model(s) must be selected (with
the highest level of complexity/risk in terms of their technical specifications) among those who make up the family, at the discretion
of the OCP.

Rectification published in the DOU of August 30, 2022.

6.1.1.4.3 Definition of the Laboratory

The criteria for defining the laboratory must follow those established in the RGCP.

6.1.1.5 Treatment of non-conformities in the Initial Assessment stage

The criteria for treating non-conformities in the Initial assessment stage must follow as defined in the RGCP.

6.1.1.6 Issuance of the Certificate of Conformity

6.1.1.6.1 The criteria for issuing the certificate of conformity must follow the requirements established in the RGCP. The certificate
must be valid for 6 (six) years.

6.1.1.6.2 In the certificate of conformity, the model(s) belonging to the family must be noted
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as per Table 2 below.

Table 2 - Notation of the model(s) belonging to the family in the certificate of conformity.

Brand Model Description Commercial barcode


(if available) of all
(Commercial Name of the (Technical description of the
versions.
Model and Commercial Model)
Reference
- Technical characteristics that
Codes, if existing)
differentiate the models from
family

- Types of Protection Applied

6.1.1.6.2 The Certificate of Conformity, as a formal instrument issued by the OCP, must comply with the requirements established by
the RGCP and complemented by the following information:

a) special conditions of safe use, when applicable;

b) complete marking in accordance with the relevant standard;

c) the following observation: The products must be installed in compliance with the relevant standards in
Electrical Installations in Explosive Atmospheres;

d) standardized note, whenever applicable, as per the following text: Installation, inspection, maintenance, repair, review and recovery
activities of equipment are the responsibility of users and must be carried out in accordance with the requirements of current
technical standards and with the manufacturer's recommendations; It is

e) the formatting of the certificate number must be in accordance with paragraph d of subitem 29.2 of ABNT NBR IEC 60079-0,
including the use of the period.

6.1.1.6.3 The Certificate of Conformity, as a formal instrument issued by the OCP, must comply with the requirements established by
the RGCP and complemented by the following information:

a) special conditions of safe use, when applicable;

b) complete marking in accordance with the relevant standard;

c) the following observation: The products must be installed in compliance with the relevant standards in
Electrical Installations in Explosive Atmospheres;

d) standardized note, whenever applicable, as per the following text: Installation, inspection, maintenance, repair, review and recovery
activities of equipment are the responsibility of users and must be carried out in accordance with the requirements of current technical
standards and with the manufacturer's recommendations;

e) the formatting of the certificate number must be in accordance with paragraph d of subitem 29.3 of ABNT NBR IEC 60079-0,
including the use of the period; It is

f) in addition to what is provided for in paragraph "e", the certificate number must be added with a numerical complement, at the end,
separated by a dash or slash, indicating the recertification sequence (001 or 1 for the 1st recertification and so on) .

Rectification published in the DOU of August 30, 2022.

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ANNEX TO INMETRO ORDINANCE No. 115/2022

6.1.2 Maintenance Assessment

The criteria for maintenance assessment must follow those established in the RGCP. The frequency of audits and maintenance tests
is 18 (eighteen) months, counting from the granting of the certificate.

6.1.2.1 Maintenance Audit of the Quality Management System and Assessment of the Production Process

The criteria for auditing the maintenance of the quality management system and evaluating the production process
must follow the requirements established in subitem 6.1.1.3 of this RAC.

6.1.2.2 Maintenance Test Plan

The criteria for the maintenance test plan must follow the requirements established in the RGCP.

6.1.2.2.1 Definition of the Tests to be carried out

6.1.2.2.1.1 The criteria for defining tests must follow the requirements established in the RGCP, and in subitem 6.1.1.4.1 of this RAC.

6.1.2.2.1.2 Tests must be carried out on the product in which non-conformity was found during the maintenance
audit or which has undergone changes that modify the original characteristics, upon evaluation by the OCP.

6.1.2.2.1.3 The necessary tests are defined by the OCP based on the assessment carried out, in accordance with 6.1.2.2.1.2.

6.1.2.2.2 Definition of Maintenance Sampling

6.1.2.2.2.1 The sampling definition must follow the general conditions set out in the RGCP.

6.1.2.2.2.2 The OCP is responsible for selecting and sealing representative samples of the product family. The
sample can be obtained on the production line, as long as the product has already been inspected and released by
the factory's quality control, in the shipping area of the manufacturing unit, as long as the product is already in the
final packaging for sale to the consumer, in conditions to have the invoice issued.

6.1.2.2.3 Definition of the Laboratory

The definition of laboratory must follow the conditions described in the RGCP.

6.1.2.3 Treatment of non-conformities in the Maintenance Assessment stage

The criteria for treating non-conformities in the maintenance assessment stage must follow the requirements
established in the RGCP.

6.1.2.4 Maintenance Confirmation

Maintenance confirmation criteria must follow the requirements established in the RGCP.

6.1.3 Recertification Assessment

The criteria for recertification assessment are established in the RGCP. The Recertification Assessment must be carried out every
6 (six) years, and must be completed by the validity date of the Certificate of Conformity.

6.1.3 Recertification Assessment

The criteria for recertification assessment are established in the RGCP. The Recertification Assessment must be
carried out every 6 (six) years, and must be completed by the validity date of the Certificate of Conformity. The type
tests provided for in subitem 6.1.1.4.1 must be carried out if there has been audit non-conformity(ies) relating to
any of the items in chapters 8 and 9 of the ISO 9001 or ABNT NBR ISO 9001 standard provided for in Table 1 of
this RAC, in any of the maintenance stages
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ANNEX TO INMETRO ORDINANCE No. 115/2022

evaluated or that, upon evaluation by the OCP, the project has undergone changes that modify the original
characteristics.

Rectification published in the DOU of August 30, 2022.

6.2 Certification Model 1b

6.2.1 Initial Assessment

6.2.1.1 Certification Request

The supplier must forward a formal request to the OCP, providing the documentation described in the RGCP.

6.2.1.2 Analysis of Request and Documentation Compliance

The criteria for analyzing the request and document compliance must follow the requirements established in the RGCP.

6.2.1.3 Initial Test Plan

The test plan criteria must follow the requirements established in the RGCP.

6.2.1.3.1 Definition of the Tests to be carried out

6.2.1.3.1.1 The criteria for defining tests must follow the requirements established in the RGCP.

6.2.1.3.1.2 Type tests must be carried out in accordance with the relevant requirements of the applicable standards
listed in item 3 of this RAC.

6.2.1.3.1.3 Documentation of routine tests carried out by the manufacturer on the products that make up the
certification batch must be presented to the OCP by the supplier.

6.2.1.3.1.4 Products that use certified components based on Inmetro regulations do not require type testing on
their components.

6.2.1.3.2 Sampling Definition

6.2.1.3.2.1 The sampling definition criteria must follow the requirements established in the RGCP.

6.2.1.3.2.2 Type tests must be carried out on 6% (six percent) of the certification batch, with a minimum of one unit.

6.2.1.3.3 Definition of the Laboratory

The definition of laboratory must follow the requirements established in the RGCP.
6.2.1.4 Issuance of the Certificate of Conformity

6.2.1.4.1 The criteria for issuing the certificate of conformity must follow the requirements established in subitem
6.1.1.6, except for the validity, which is undetermined, and complemented by the following information:

a) the respective serial numbers of the certified models;

b) the number of the certificate of conformity of origin, when applicable; It is

c) full marking in accordance with the relevant standard or certificate of origin (when
applicable).

6.3 Status Certification Model for Imported Product (SPI)

6.3.1 Initial Assessment

6.3.1.1 Certification Request

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6.3.1.1.1 The supplier must forward a formal request to the OCP, providing the documentation described in the RGCP, plus the
documentation defined in subitems 6.3.1.1.4 and 6.3.1.1.5 of this RAC.

6.3.1.1.1 The supplier must forward a formal request to the OCP, providing the documentation described in the RGCP, where
applicable, plus the documentation defined in subitems 6.3.1.1.4 and 6.3.1.1.5 of this RAC.

Rectification published in the DOU of August 30, 2022.

6.3.1.1.2 This certification model is not applicable to the following products: installation accessories (ie: cable glands, flexible conduits,
unions, etc.), luminaires, electronic ballasts for fluorescent lamps, hand torches, projectors, empty casings, electric motors, connection
boxes, solenoid valves and components for signaling and control, except when these are part of a modular process unit (SKID).

6.3.1.1.3 For the exclusive purpose of repairing already installed systems, this situation being duly proven by the supplier, this
certification model is applicable to the products described in subitem 6.3.1.1.2 of this RAC.

6.3.1.1.4 The requesting supplier is responsible for forwarding a formal statement to the OCP attesting that:

a) certification does not exceed 20 (twenty) units of the same product model, regardless of the
Certificate of Conformity or equivalent document presented; It is

b) the object of the request was not certified in accordance with the requirements of this RAC, in any OCP,
within a period of less than 6 (six) months of this request.

6.3.1.1.5 The requesting supplier is responsible for forwarding the following documents to the OCP:

a) Certificate of Conformity or equivalent document, issued by a third party, valid for the complete equipment, covering the product
model subject to the request, and containing at least: type of protection, group of gases or dust, temperature class or maximum
temperature surface and reference technical standards;

6.3.1.1.5 The requesting supplier is responsible for forwarding the following documents to the OCP:

a) Certificate of Conformity or equivalent document, issued by a third party, valid for the
complete equipment, covering the model of the product subject to the request, and containing at least: type of protection, group of
gases or dust, temperature class or maximum surface temperature and reference to technical standards;

Rectification published in the DOU of August 30, 2022.

b) Certificate of Conformity for the Quality Management System, issued by a third party, in force, covering the production plant of the
product subject to the request. This certificate can be replaced by a production monitoring report, carried out by the Organization
responsible for issuing the document referenced in paragraph “a”;

c) invoice of entry for imported products or equivalent document from the Federal Revenue
Brazilian; It is

d) installation manual and information regarding conditions of safe use in language


Portuguese and in the version to be made available to the end user.

6.3.1.2 Analysis of Request and Documentation Compliance

6.3.1.2.1 The criteria for analyzing the request and document compliance must follow the requirements established in the RGCP.

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6.3.1.2.2 The OCP is responsible for evaluating the documentation presented considering the following conditions:

a) not accept the presentation of different documents referenced in paragraph a of subitem 6.3.1.1.5
of this RAC, for different certification processes;

b) adopt the date of manufacture of the equipment as a reference for analysis;

c) observe the validity criteria of the documents referenced in paragraphs “a” and “b” of subitem 6.3.1.1.5 of this RAC, as
an example for ATEX certificates, verify the validity of the PQAN;

d) observe, in the documents referenced in paragraph “a” of subitem 6.3.1.1.5 of this RAC, the technical standards and
characteristics applicable to the product subject to certification, such as: types of protection, group of gases or dust,
temperature class or maximum surface temperature, ambient temperature range, degree of protection, entity
parameters or equivalent markings from other foreign systems;

e) list in the documentation of the certification process, in a unique way (ie: serial number), the identification of each unit
covered by the certification process, including for each component of a modular process unit (SKID); It is

f) exempt, if the requesting supplier is the user of the product, the presentation of the installation manual and information
relating to the conditions of safe use in Portuguese.

6.3.1.2.2 The OCP is responsible for evaluating the documentation presented considering the following conditions:

a) not accept the presentation of different documents referenced in paragraph a of subitem 6.3.1.1.5 of this RAC, for
different certification processes;
b) observe the validity criteria of the documents referenced in paragraphs "a" and "b" of the subitem
6.3.1.1.5 of this RAC;
c) observe, in the documents referenced in paragraph "a" of subitem 6.3.1.1.5 of this RAC, the technical standards
and characteristics applicable to the product subject to certification, such as: types of protection, group of gases
or dust, temperature class or maximum surface temperature, ambient temperature range, degree of protection,
entity parameters or equivalent markings from other foreign systems;

d) list in the documentation of the certification process, in a unique way (ie: serial number), the identification of each
unit covered by the certification process, including for each component of a modular process unit (SKID); It is

e) exempt, if the requesting supplier is the user of the product, the presentation of the installation manual and
information relating to the conditions of safe use in Portuguese, as well as documentation proving compliance
with item 8 of this document (Complaint Handling ).

Rectification published in the DOU of August 30, 2022.

6.3.1.3 Initial Audit of the Quality Management System and Assessment of the Production Process

The Initial Audit of the Quality Management System and Evaluation of the Production Process is not applicable
to this certification model.

6.3.1.3 Initial Audit of the Quality Management System and Assessment of the Production Process

The Initial Audit of the Quality Management System and Assessment of the Production Process is not applicable to this
certification model. Item 7.3 of the RGCP (audit of Complaints Handling) is also not applicable.

Rectification published in the DOU of August 30, 2022.


6.3.1.4 Initial Test Plan

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The initial test plan is not applicable to this certification model.


6.3.1.4.1 Definition of the Tests to be carried out
The definition of tests to be carried out is not applicable to this certification model.
6.3.1.4.2 Sampling Definition
The definition of sampling is not applicable to this certification model.
6.3.1.4.3 Definition of the Laboratory
The laboratory definition is not applicable to this certification model.
6.3.1.5 Treatment of non-conformities in the Initial Assessment stage
The treatment of non-conformities in the initial assessment stage described in this certification model is not
applicable.
6.3.2 Product Inspection
In order to confirm whether the imported product corresponds to the documentation presented by the applicant,
in accordance with 6.3.1.1, the OCP is responsible for carrying out an inspection (product inspection) which
must be complemented by photographic records, before connecting, installing or operating the product.
6.3.3 Issuance of the Certificate of Conformity

The criteria for issuing the certificate of conformity must follow the requirements established in subitem 6.2.1.4.

7 CERTIFICATION BASED ON ACCEPTANCE OF TEST REPORTS


National OCPs may issue certificates of compliance based on certifications carried out by
Certification Bodies (ExCB) approved by IECEx, through analysis of test reports
(ExTR) issued by laboratories (ExTL), when the following requirements are met:
a) it has been verified, in the Test Report (ExTR), that the test methods and sampling methodologies are
equivalent to those defined in this RAC;
b) it has been verified, in the Quality Audit Report (QAR), that the procedure adopted is equivalent to that
defined in this RAC;
c) the test reports (ExTR) have been issued by an approved Testing Laboratory (ExTL) that operates within
the IECEx system.
Note: information about products certified by the IECEx International Certification System can be obtained
from the online database of certificates of conformity, available at the following website: https://www.iecex-
certs.com/#/home
Note 1: information about products certified by the IECEx International Certification System can be obtained
from the online database of certificates of conformity, available at the following website: https://www.iecex-
certs.com/#/home
Note 2: The provisions of this item 7 apply exclusively to certification model 5."
Rectification published in the DOU of August 30, 2022.

8 COMPLAINT HANDLING
The criteria for handling complaints must follow the requirements established in the RGCP.

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9 ACTIVITIES PERFORMED BY OCP ACCREDITED BY IAF MLA MEMBER

The criteria for activities carried out by an OCP accredited by a member of the IAF MLA must follow the
requirements established in the RGCP.

10 TRANSFER OF CERTIFICATION

The criteria for transferring certification must follow the requirements established in the RGCP.

11 CLOSURE OF CERTIFICATION

The criteria for closing certification must follow the requirements established in the RGCP.

12 COMPLIANCE IDENTIFICATION SEAL

The criteria for the Conformity Identification Seal are defined in the RGCP and in Annex II.

13 AUTHORIZATION TO USE THE COMPLIANCE IDENTIFICATION SEAL

The criteria for authorizing the use of the Conformity Identification Seal must follow the requirements established in the RGCP.

14 RESPONSIBILITIES AND OBLIGATIONS

The criteria for responsibilities and obligations must follow the requirements established in the RGCP.

15 MARKET FOLLOW-UP

The criteria for market monitoring must follow the requirements established in the RGCP.

16 PENALTIES

The criteria for penalties must follow the requirements established in the RGCP.

17 COMPLAINTS, COMPLAINTS AND SUGGESTIONS

The criteria for reports, complaints and suggestions must follow the requirements established in the RGCP.

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ANNEX A - ADDITIONAL TECHNICAL REQUIREMENTS FOR THE ASSESSMENT OF THE QMS

1. DOCUMENT CONTROL

In addition to subitems 7.5.2 and 7.5.3 of ISO 9001:2015 or ABNT NBR ISO 9001:2015, the following
requirements apply:

a) Equipment documents (descriptions and drawings) and the manufacturing unit must be controlled;

b) Documented procedures must guarantee that the information in the manufacturing unit's documents refers to
the equipment subject to certification. Related documents must comply with the drawings approved in the
certification (related documents are those used in the manufacturing process);

c) The quality system must guarantee that no factor (type, characteristic, position, etc.) defined in the Test or
Assessment Report or in the Certificate of Conformity and technical documentation (e.g. certification drawings)
is changed;

d) There must be a documented system that references all drawings related to the relevant certification drawings;

e) When there are certification drawings that are common to more than one Test Report or
Assessment or in the Certificate of Conformity, there must be a documented system that ensures simultaneous
supplementary actions in the event of changes to such drawings;

Note: Some manufacturers use common components with the same number of designs for more than one
product. Some of these products may have different people responsible for them. Therefore, if a product with a
common component and design number is revised to meet a need and its certificate is revised, there needs to
be a system in place to ensure that any other certificate referencing the same component is also being revised
to ensure that other products comply with the equipment documents.

f) When a manufacturer has designs for products not intended for use in explosive atmospheres, there must be
a documented system that allows clear identification of the designs
related documents and certification drawings;

Note: The following examples can be used:


- Use of visual brands; It is

- Use of an exclusive series for numbering drawings, e.g. all drawings relating to certification having an “Ex”
prefix in the numbering.

g) The manufacturer must indicate in a document which OCP is responsible for certification; It is

h) When equipment or manufacturer documents are passed on to a third party, they must be provided in a way
to avoid misinterpretation.

2. RECORDS CONTROL

Subitems 7.5.2 and 7.5.3 of ISO 9001:2015 or ABNT NBR ISO 9001:2015 apply.

Note: It is in the manufacturer's best interest to retain adequate quality records that demonstrate product
compliance. Examples of documents that require control and retention are:

- those that arise from regulatory requirements;

- customer request;

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- critical contract analysis;

- training records;

- test and inspection data;

- calibration data;

- evaluation of subcontractors; It is

- shipping data (customer, shipping date and quantity, including serial numbers when available).

3. PRODUCT REALIZATION PLANNING

In addition to subitem 8.1 of ISO 9001:2015 or ABNT NBR ISO 9001:2015, the following subitems apply.

3.1 Explosion-proof enclosures (Ex d)


3.1.1 Cast materials

Molten materials must be subjected to inspection that demonstrates their conformity. The following must be
checked, for example:

- the thickness of the walls (including those that have not been machined); It is

- the existence of cracks, the inclusion of foreign material, bubbles and porosity (visually or by a test method,
depending on the criticality).

Repairing the porosity of cast materials by impregnation methods, e.g. through the use of silicone, is not
recommended. When a cast material is repaired by welding, it will be subject to the requirements applicable to
machined casings, e.g. routine overpressure testing.

3.1.2 Machining

Machined materials must undergo inspection to demonstrate their conformity. The following must be
checked, for example:

- the flatness of explosion-proof flanged joints;

- the surface roughness of all non-threaded explosion-proof joints;

- the fit of all explosion-proof threaded joints (e.g. cable entries and access covers
threaded);

- the depth of the holes and threads to ensure an adequate thickness of the residual wall;

- the dimensional requirements of all explosion-proof joints.

3.1.3 Cemented joints and encapsulated assemblies

Documented procedures must indicate the following:

a) the validity and storage time of the cement and encapsulating compound;

b) the proportions of the mixture;

c) surface preparation (degreasing or equivalent is normally required immediately before operation, to ensure
good adhesion);

d) the application, for example, of filling instructions, free of bubbles and temperature conditions; It is

e) curing, which must include: the curing period, any relevant environmental factors, measures to

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ensure that the product is not manipulated during the curing period.

3.1.4 Routine pressure test


The purpose of the test is to verify that the casing does not suffer permanent damage or deformation and
that there are no leaks from the casing during the test other than through construction gaps, e.g.
explosion-proof joints.
Leaks through cemented joints or encapsulated assemblies constitute failures.
The test can be carried out once with a complete assembly, or a series of applications on each part of the
enclosure. Enclosures that have more than one compartment must have each compartment tested individually.
The method used must ensure that the complete assembly or its parts are subjected to representative
stresses, e.g. that the actual enclosure closing system is used. Fixing devices that affect the mechanical
properties of the type of protection invalidate the test.

Hydraulic methods are recommended due to safety considerations and the difficulties in detecting leaks with
pneumatic methods.
The test installation must be suitable to readily supply the required pressure during the test period. Leaks
through explosion-proof joints can be reduced by the use of gaskets or O-rings.

The pressure gauge must be calibrated, have adequate resolution and range, and be located so as not to
invalidate the test (e.g. due to pressure drop in the pipes).
The test method must enable any leakage to be monitored during the test period.

Routine pressure test verification should include inspecting the product for damage or deformation, e.g. that
explosion-proof flanged joints are still within specified tolerances and that closures are not deformed.

3.1.5 Flanged joints


Flanged joints must be checked after final assembly to ensure that the specified gap has not been exceeded.

3.1.6 Sintered components


Sintered materials are used in many products, such as gas detectors and speakers.
When an OCP issues a Certificate of Conformity involving such components, the design parameters for the
sintered components typically cover three factors:
- maximum pore size;
- minimum density;

- diameter and thickness of the sintered material.

The purpose of this item is to provide guidance to manufacturers on how they can demonstrate that sintered
components meet design requirements as detailed in the Test or Assessment Report or Certificate of
Conformity.
3.1.6.1 Verification Guidance
There are three options available:
- the manufacturer conducts checks and tests;
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- the manufacturer, through a contract, carries out periodic and documented monitoring of the sinter supplier, accepting a
declaration of conformity from the sinter supplier;

- the manufacturer accepts the sintered material with a declaration of conformity from the supplier, which has an implemented quality
system and Certificate containing the manufacture of sintered materials in its scope.

3.1.6.2 Tests

Testing for the three verification options must be carried out in accordance with the requirements of the Test or Assessment Report
or the Certificate of Conformity. Typical testing requirements are presented in ISO 4003 and ISO 2738.

The test may be conducted on a sample basis, provided that the sampling is not less than 1% of the batch size or 10 units,
whichever is greater.

When tests are conducted on a sample basis to determine pore size and sinter density, the results must be calculated to establish
the standard deviation (ÿ) for sampling, that is:

ÿP is the standard deviation for pore size; It is

ÿD is the standard deviation for density.

The maximum pore size must not exceed and the minimum density must remain equal to or be greater than the values set out in
the Certificate of Conformity when 3ÿ is considered. For this reason the average sampling value plus 3 ÿP (for pore size) and minus
3 ÿD (for density) should not invalidate the requirements of the Test or Assessment Report or the Certificate of Conformity.

3.1.6.3 Test Examples

The following examples are provided as a guide:

- Example 1 (pore size):

Maximum size allowed for

the pore, as specified in

a certificate of conformity = 150 µm

Average value = 140 ÿm

Standard deviation (ÿP) = 2 ÿm

Therefore, maximum value = 140 + (2 x 3) = 146 ÿm (approved)

If the standard deviation (ÿP) is = 5 ÿm

So the maximum value = 140 + (5 x 3) = 155 ÿm (fail)

- Example 2 (density):

Minimum allowable density,

as specified in the

certificate of conformity = 5 gcm-3

Average value = 5.3 gcm-3

Standard deviation (ÿD ) = 0.05 gcm-3

Therefore, minimum value = 5.3 - (0.05 x 3) = 5.15 gcm-3 (approved)

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If the standard deviation (ÿD ) is = 0.12 gcm-3

So the minimum value = 5.3 - (0.12 x 3) = 4.94 gcm-3 (fail)

Note: In some cases the sintered material is built directly into a solid casing. To establish the density value, the following formula
must be used:

Rewritten as follows:

Where:

ÿW is the density of water;

m1 is just the envelope, heavy in the air;

m2 is just the casing, weighed in water;

m3 is the casing and the sintered material (assembled), weighed in air;

m4 is the coated mount, weighed in air; It is

m5 is coated mount, heavy in water.

3.1.6.4 Purchase Information

The manufacturer must ensure that purchasing documents include the following:

- The specification of the sintered material;

- Dimensional requirements;

- The maximum pore size; It is

- The minimum density of the sintered material.

3.1.6.5 Pre-tested components

When the manufacturer does not conduct its own tests, the supplier must present the following in a declaration of conformity:

- The size of the manufactured batch;

- The sampling size to define the maximum pore size and minimum density;

- The number of components supplied;

- Maximum pore size and minimum density calculated (mean values and standard deviations must be provided).

3.1.6.6 Receipt control

Upon receipt, the manufacturer must:

- Verify the tests carried out described in the declaration of conformity;

- Check the compatibility of the requirements in the purchase order with the declaration of conformity;

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- Conduct the tests (if carried out at the manufacturing unit); It is

- Conduct statistical verification in relation to the sintered material.

3.2 Intrinsic safety (Ex i)

3.2.1 Intrinsically safe product components

The following characteristics must be verified with respect to the following components for use in intrinsically safe equipment and
associated equipment. This typically involves checking the marking of components or packaging and may be carried out using
statistical techniques if appropriate:

Resistors: value, power, type.

Capacitors: value, tolerance, type.

Piezo-electric devices: manufacturer, type, capacitance.

type, inductance, dc resistance, number of turns, wire section and


Inductive components: material and, if appropriate, core and coil specification and material.

Transformers: type, manufacturer, insulation, voltage.

Semi-conductors:

Diodes

Zener diodes
code and, if appropriate, manufacturer.
Transistors

Integrated circuits

Thyristors

Batteries: manufacturer and type or standardized designation.

Fuses: manufacturer, type and value.

Insulating materials: specification, dimensions and, if appropriate, code.

Connectors:
code and, if appropriate, manufacturer.
(e.g. plugs, sockets and terminals)

3.2.2 Printed circuit boards (PCBs)

3.2.2.1 Unpopulated PCBs

3.2.2.1.1 For high-density or complex PCBs, e.g. multilayer PCBs, the batch may be accepted with a declaration of conformity. The
declaration must demonstrate conformity to the purchasing documents, e.g. a quality plan that lists the factors that together
demonstrate the conformity of the product.

3.2.2.1.2 For single or double PCBs, the final artwork must be visually verified using a photographic negative (transparency), a
certified drawing or a controlled inspection sample.

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ANNEX TO INMETRO ORDINANCE No. 115/2022

3.2.2.1.3 Purchasing documents must specify copper thickness, PCB thickness and CTI values.

3.2.2.2 Populated PCBs

3.2.2.2.1 Varnish and coatings must be controlled with respect to material specification, coating effectiveness and, if required,
application of two independent layers, ie the first layer must cure or dry for an appropriate time before applying the second layer.

3.2.2.2.2 For PCBs, the manufacturer must maintain a list of safety-critical components used in production (e.g. resistors and zener
diodes), as defined by the OCP that issued the Certificate of Conformity. The components on this list must be checked 100%. This
can be accomplished by:

- a visual inspection; or

- for SMD components, ensuring correct loading of pick and place machines and a visual inspection of correct placement; and

- by automatic test equipment provided that the equipment individually checks each critical component and by visual inspection
conducted to verify the component code in assemblies with diodes or zener diodes.

Note: If the pick and place machine selects the component coil based on measuring the component value, the measuring function
must be calibrated.

3.2.2.2.3 Documented procedures must be provided to ensure that routines for assembly and welding are defined.

3.2.2.2.4 The segregations of manually assembled PCBs must be checked 100%.

3.2.3 Assemblies

3.2.3.1 Documented procedures must ensure that production documentation includes all relevant product design variations.

3.2.3.2 Production documentation must indicate all safety-critical components and, in the case of encapsulated parts, the
manufacturer, type, mixture and depth of encapsulant.

3.2.3.3 Documented procedures must ensure that segregation between related parts (e.g. terminals) and cabling is maintained, and
that specified colors and/or labels are used.

3.2.3.4 Seals must be checked for compatibility with the product's degree of protection.

3.2.4 Tests

Any tests in the Test or Assessment Report or Certificate of Conformity, e.g. high voltage tests on complete assemblies or individual
components such as transformers, must be controlled by documented procedures and conducted at 100% unless permitted by
Applicable Technical Standard.

3.2.5 Assemblies of intrinsically safe circuits in Ex d, Ex p or Ex q enclosures

When Ex d, Ex p or Ex q enclosures contain intrinsically safe circuits, precautions must be taken, as indicated in the Test or
Assessment Report or Certificate of Conformity, to ensure that other items listed in the Test or Assessment Report are selected,
assembled and installed according to the referenced drawings.

3.3 Increased security (Ex e)

3.3.1 Degree of Protection

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ANNEX TO INMETRO ORDINANCE No. 115/2022

Documented procedures must ensure that the following are verified:

a) the continuity of welding;

b) fitting gaskets and sealing rings;

c) the fitting of molded tongues and grooves (male and female); It is

d) the application of cements.

3.3.2 Internal wiring and contact integrity

Documented procedures must ensure that they are verified if:

a) the wiring is effectively fixed;

b) the wiring is correctly terminated, e.g. the insulation of the connecting wires has not been removed excessively (normally 1 mm
into the terminal metal); It is

c) the wiring insulation has appropriate thermal characteristics.

3.3.3 Rotating machines

Documented procedures must ensure that:

a) the rotor and busbar termination connections are correctly segregated and are not subject to undue stress;

b) the air gap is checked (between rotor and stator) or calculated based on defined tolerances;

c) the fan clearance is checked; It is

d) bearing clearance is checked.

3.3.4 Windings

Documented procedures must ensure that:

a) the impregnations are free of bubbles;

b) insulation materials are those of the specification;

c) the protection of conductors is checked; It is

d) when protective devices (e.g. thermal) are specified in the Test or Assessment Report or in the Certificate of Conformity, they
must be of the type and location specified.

3.3.5 Tests

All tests must be documented. Typically, trials should include:

a) dielectric tests; It is

b) insulation of bearings for rotating machines.

3.4 Pressurized equipment (Ex p)

3.4.1 Degree of protection

Documented procedures must ensure that the following are verified:

a) the continuity of welding;

b) fitting gaskets and sealing rings;

c) the fitting of molded tongues and grooves (male and female); It is

d) the application of cements.

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ANNEX TO INMETRO ORDINANCE No. 115/2022

3.4.2 Tests

All tests must be documented. Typically, these tests should include:

a) an overpressure test, at the pressure specified in the Test or Assessment Report or in the
Certificate of conformity; It is

b) a loss test to ensure that the specified loss rate is not exceeded.

3.5 Encapsulation (Ex m)

3.5.1 Production documentation

Thermal protections (e.g. thermal fuses) must be of the specified type and positioned in accordance with the certification drawings.

The guidelines presented in subitem 3.1.3 of this annex are applicable.

3.5.2 Tests

All tests must be documented. Typical assays include:

a) visual inspection; It is

b) verification of dielectric characteristics.

3.6 Oil immersion (Ex o)

All tests must be documented. Typical assays include:

a) reduced pressure test (only for sealed enclosures); It is

b) overpressure test (sealed and unsealed casings).

3.7 Immersion in sand

3.7.1 Material control

The material must be of a defined size and type. There must be evidence such as verification of the flammability of the enclosure
materials and these materials must be those specified in the Test or Assessment Report or the Certificate of Conformity.

3.7.2 Filling

Filling must be done without bubbles. It is clearly necessary to ensure that no bubbles are created after filling by oscillating
movement. The completion process must be documented and the documentation must include verification criteria.

3.7.3 Degree of protection

Documented procedures must ensure that the following are verified:

a) the continuity of welding;

b) fitting gaskets and sealing rings;

c) the fitting of molded tongues and grooves (male and female); It is

d) the application of cements.

3.7.4 Tests

All tests must be documented. Typical assays include:

a) pressure test; It is

b) dielectric strength test of the filling material.

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ANNEX TO INMETRO ORDINANCE No. 115/2022

4. VERIFICATION OF THE PRODUCT PURCHASED

In addition to subitems 8.4.2, 8.4.3 and 8.6 of ISO 9001:2015 or ABNT NBR ISO 9001:2015, the following
requirements apply:

a) For purchased products that may compromise the type of protection, the manufacturer must determine and implement checks that
demonstrate the product's compliance with the standards listed in the test report and the Certificate of Conformity, taking into account
the nature of the product and of the Supplier.

b) When deciding which type of verification is required for a particular purchased product, the manufacturer
must consider the nature of the purchased product, the supplier, and how critical it is to the type of protection in
question.

Note: When considering whether a supplier should perform verification, the manufacturer must take into account
the results of its assessments conducted in the purchasing process. The decision must reflect the supplier's
competence, including whether it has a quality system that covers the activity, resources, e.g. equipment, and
professionals with appropriate qualifications and experience. This last point is particularly significant when a
decision is required, as in the case of inspection of explosion-proof castings. When the manufacturer delegates
to the supplier the performance of a test or inspection relevant to the type of protection, the material must be
supplied with a declaration of conformity confirming its performance.

c) When the supplier has been assessed and documented objective evidence has been obtained that
demonstrates that the supplier is fully capable of producing and verifying the product or service, no further
verification of the product or service is required if a declaration of conformity is provided with each batch or
product.

d) When the Certificate of Conformity specifies routine tests or inspections, these must be carried out on each
and every product. They can be carried out by the supplier or the manufacturer.
When carried out by the supplier, they must be specified in the purchasing documents, e.g. by a quality plan,
and confirmed by the supplier, e.g. by a declaration of conformity.

e) If verification of a product cannot be carried out after manufacture, e.g. the internal parts of encapsulated
intrinsically safe circuits, the product can only be accepted if provided with a declaration of conformity. This
should specifically indicate conformity to purchasing documents, e.g. a quality plan, which lists the factors that
together demonstrate the conformity of the product.

f) If sampling tests or inspections are permitted, they must be conducted in such a way as to demonstrate compliance of the entire
batch.

g) When the supplier requires training or specialized knowledge and training to carry out a check, these must be
documented and records of the training must be maintained.

h) When the manufacturer decides not to carry out inspections and tests at its facilities, the inspections and
tests must be carried out at the supplier's facilities under the responsibility of the manufacturer.

i) When a supplier delivers a product with evidence of conformity for application in explosive atmospheres (e.g.
a test report or a Certificate of Conformity), no additional checks are required, unless the manufacturer deems it
necessary.

5. PRODUCTION CONTROL AND SERVICE SUPPLY


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ANNEX TO INMETRO ORDINANCE No. 115/2022

Subitems 8.5.1 and 8.5.5 of ISO 9001:2015 or ABNT NBR ISO 9001:2015 apply.
Note: The manufacturer must present its procedures, production equipment, work environments and installations
for inspection and testing, which together guarantee the conformity of the product, as described in the Certificate
of Conformity and in accordance with the certification requirements.

6. IDENTIFICATION AND TRACEABILITY


In addition to subitem 8.5.2 of ISO 9001:2015 or ABNT NBR ISO 9001:2015, the following requirements apply:

a) The manufacturer must establish and maintain procedures for product identification during all stages of
production, testing, final inspection and marketing; It is
b) Traceability is required in relation to the final product and its significant parts.
Note: Significant parts are, e.g., a printed circuit board (PCB) of an intrinsically safe circuit, but not each
electronic component of a PCB.

7. PRODUCT PRESERVATION
Subitem 8.5.4 of ISO 9001:2015 or ABNT NBR ISO 9001:2015 applies.
Note: The manufacturer must provide an instruction manual in Portuguese to its customers to enable the safe
use of the product. If deemed necessary by the manufacturer, instructions shall contain special requirements
for installation and maintenance of the product. This can be specified in the Certificate. Procedures may be
required for life-limited components if they affect the type of protection, such as batteries.

8. CONTROL OF MEASUREMENT AND MONITORING DEVICES


In addition to subitem 7.1.5 of ISO 9001:2015 or ABNT NBR ISO 9001:2015, the following requirements apply:

Note: Compliance with the mentioned subitem can be done through the use of an accredited calibration
laboratory (which can demonstrate to the OCP that it acts in accordance with an internationally recognized
standard and is, preferably, covered by a multilateral agreement) and by obtaining a certificate bearing the
accreditation logo. When this certificate is obtained, the laboratory does not need to undergo additional
evaluation.
a) When a calibration certificate does not bear the accreditation logo of a national accreditation authority, each
calibration certificate shall include at least the following information:

- an unambiguous identification of the calibrated item;


- evidence that measurements are traceable to national or international measurement standards;
- the calibration method;
- a declaration of conformity to any representative specification;
- calibration results;
- measurement uncertainty, if necessary;
- environmental conditions, when relevant;
- the date of calibration;

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ANNEX TO INMETRO ORDINANCE No. 115/2022

- the signature of the person responsible for issuing the certificate;

- the name and address of the issuing organization and the date of issue of the certificate; It is

- unambiguous identification of the calibration certificate.

b) When a calibration certificate does not bear the accreditation logo of a national accreditation authority or does not
contain the information listed in the paragraph above, the manufacturer must demonstrate a valid relationship with
national or international measurement standards by other means (e.g. . documented evaluation of the industrial plant).

9. CUSTOMER SATISFACTION

Subitem 9.1.2 of ISO 9001:2015 or ABNT NBR ISO 9001:2015 applies.

Note: For the purposes of this RAC, customer satisfaction is related to the product's compliance with the requirements
of the standards, test report and certificate.

10. PROCESS MEASUREMENT AND MONITORING

Subitem 9.1.1 of ISO 9001:2015 or ABNT NBR ISO 9001:2015 applies.

Note: If a process may affect the integrity of the protection type, and if the resulting integrity cannot be verified after
manufacturing (e.g. the environmental conditions required for curing an encapsulant), that specific process must be
measured and monitored and documented evidence demonstrating compliance with required parameters must be
maintained (see also B.3).

11. PRODUCT MEASUREMENT AND MONITORING

Subitem 8.6 of ISO 9001:2015 or ABNT NBR ISO 9001:2015 applies.

Note: If routine tests are required by the equipment certificate and documents, these tests must be carried out as
specified, and the use of sampling techniques is not permitted. If practicable, the marking label shall not be affixed until
final inspection and testing have been satisfactorily completed.

12. CONTROL OF NON-CONFORMING PRODUCT

In addition to subitems 8.7 and 10.2 of ISO 9001:2015 or ABNT NBR ISO 9001:2015, the following requirements apply:

Note: One of the purposes of this item is to avoid non-conformities in the products supplied.

a) The manufacturer must maintain a system so that, in the event that a product not conforming to the standards listed
in the certificate of conformity has been supplied, the customer can be identified.

b) The manufacturer must take actions appropriate to the degree of risk, when non-conforming products have been supplied to the
customer.

Note: It is recommended that the manufacturer inform the OCP responsible for issuing the Certificate of Conformity.

c) If an unsafe or non-conforming product has been supplied to a customer, the manufacturer must inform the customer
and the OCP responsible for issuing the certificate in writing.

d) If it is not possible to trace the unsafe product (e.g. product supplied by a distributor, or due to

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ANNEX TO INMETRO ORDINANCE No. 115/2022

high volume of products such as cable glands), an advertisement should be placed in appropriate publications recommending
actions to be taken.

e) For all non-conforming products that have been supplied to customers, the manufacturer must maintain, for a minimum period
of 10 years, records of:

- serial numbers or identification of the products supplied;

- the customer who received the product;

- the action taken to inform customers and the OCP in the case of a non-compliant product with affected safety; It is

- the action taken to implement corrective and preventive actions.

f) Concessions are not allowed for products that do not comply with the design as defined in the test report, the Certificate of
Conformity and the listed technical documentation.

13. CORRECTIVE ACTION

Subitem 10.2 of ISO 9001:2015 or ABNT NBR ISO 9001:2015 applies.

14. PREVENTIVE ACTION

Subitems 6.1 and 10.3 of ISO 9001:2015 or ABNT NBR ISO 9001:2015 apply.

15. ADDITIONAL REQUIREMENTS

If requirements from ISO 9001:2015 or ABNT NBR ISO 9001:2015 are used in addition to those listed in Table 1 of subitem
6.1.1.3.2 of the RAC, additional requirements to those listed in this Annex may be used,
specific to the explosive area, in accordance with the relevant standard.

1. When evaluating the QMS and the production process, in addition to applying the requirements set out in Table 1 of subitem 6.1.1.3.2 of
the RAC, the corresponding requirements of the ABNT NBR ISO IEC 80079-34:2020 standard must be observed.

2. If requirements from ABNT NBR ISO 9001:2015 are used in addition to those listed in Table 1 of subitem 6.1.1.3.2 of the RAC, the
corresponding requirements of the ABNT NBR ISO IEC 80079-34:2020 standard apply to the additional requirements. .

Rectification published in the DOU of August 30, 2022.

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ANNEX TO INMETRO ORDINANCE No. 115/2022

ANNEX II – COMPLIANCE IDENTIFICATION SEAL

1. Conformity Identification Seal on the Product


1.1 The Conformity Identification Seal must be applied to Electrical Equipment for Explosive Atmospheres
in a legible, durable and indelible manner.
1.2 All products, regardless of the certification model adopted, must bear the Conformity Identification Seal
as shown in Figure 1. Alternatively, when there is not enough space on the product to display this seal, the
use of the compact version is permitted, as per
Figure 2, respecting the minimum seal dimension of 11 mm in length.

Figure 1 - Conformity Identification Seals for the product

Caption of Figure 1:
Field 1 - Complete marking and identification in accordance with ABNT NBR IEC 60079
Field 2 - Certificate number, in accordance with ABNT NBR IEC 60079-0, including the letters “X” or “U”,
when applicable.

Caption of Figure 1:

Field 1 - Complete marking and identification in accordance with ABNT NBR IEC 60079

Field 2 - Certificate number, in accordance with ABNT NBR IEC 60079-0, including the letters "X" or "U",
when applicable, excluding the complement provided for in item "f" of subitem 6.1.1.6.3 of the RAC.

Note: The marking of fields 1 and 2 may differ from the layout provided in Figure 1.
Rectification published in the DOU of August 30, 2022.

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ANNEX TO INMETRO ORDINANCE No. 115/2022

Figure 2 - Compact Conformity Identification Seal for the product

1.3 Products certified according to the Situation for Imported Product (SPI) model must bear on the Seal, in
addition to the Certificate of Conformity number, the Portuguese language version of
all warnings displayed, especially when there is a special installation requirement in the original certificate.

1.4 When there are no dimensional conditions for displaying any of the Seal options, it can be omitted, however
the products must bear at least the Inmetro and OCP logo without their respective names, the Certificate of
Conformity number and the full marking in accordance with applicable standards.

1.4 When there are no dimensional conditions for displaying any of the Seal options, it can be omitted, however
the products must bear at least the OCP logo without its respective name, the Certificate of Conformity number
and the complete marking in accordance with the applicable standards. In this case, the product must contain
packaging, individual or multiple, on which the Conformity Identification Seal must be affixed as per item 2
below).
Rectification published in the DOU of August 30, 2022.

2. Conformity Identification Seal on Packaging


2.1 The Conformity Identification Seal for product packaging can be stamped, printed or glued, as long as it
meets the minimum dimensions, being 50 mm long, as shown in Figure 3.

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ANNEX TO INMETRO ORDINANCE No. 115/2022

Figure 3 - Conformity Identification Seals for packaging

2.2 This seal is not applicable to the Situation Model for Imported Product (SPI).

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