BUSINESS ASSURANCE

CONFORMITY ASSESSMENT
FOR NON-ELECTRICAL
ATEX & IECEx PRODUCTS
A practical guide

SAFER, SMARTER, GREENER

02
CONFORMITY
ASSESSMENT
FOR NON-ELECTRICAL
ATEX PRODUCTS
The intention of this document is to give manufacturers a helpful
and informative guide to navigating the conformity assessment
process for non-electrical ATEX equipment for all categories of
equipment.

Although the focus of this guide is ATEX, these same principles

should be used to prepare for IECEx compliance if required.
Manufacturers will need to engage the services of an IECEx
Certification Body in all cases to obtain a Certificate of Conformity
as IECEx does not permit self-declaration of conformity.

03
 Intended zone of use and
category of the equipment
The first step is to identify the intended Hazardous The table below shows the relationship between
Area zone of use for the equipment. This enables the intended location of use and necessary level of
manufacturer to determine the relevant Category of protection of equipment.
equipment, under ATEX and Equipment Protection
Level under IECEx, that is needed in this application.

The equipment Category (ATEX) and Equipment

Protection Level (IEC) ensures that the end
user can easily select equipment which has the
necessary level of safety to permit safe use in the
corresponding hazardous area.

Intended Location of Needed Level of

Equipment in Service Protection of the Equipment

Group Zone of Category of Equipment Protec-

(ATEX) Intended Use Equipment (ATEX) tion Level (IEC)

I (Mines susceptible 0 1 Ma
to firedamp) 1 2 Mb

0 1 Ga

II (Gas Atmospheres) 1 2 Gb

2 3 Gc

20 1 Da

III (Dust Atmospheres) 21 2 Db

22 3 Dc

04
 Conformity assessment
routes available
ATEX, like the other New Approach Directives
employs a risk based approach to conformity
assessment. The most onerous technical
requirements and conformity assessment scrutiny
apply to the highest risk applications. In high and
very high risk applications, it is mandatory to seek
the involvement of a Notified Body.
In all cases, the manufacturer must do the same
thorough and high quality evaluation of compliance
to the harmonized standards, to ensure that the
equipment is safe for the intended zone of use.
The ultimate responsibility remains with
the manufacturer, which means it is critical
that manufacturers can demonstrate that a
comprehensive conformity assessment was
conducted.
It is quite common that manufacturers engage the
involvement of a Notified Body, even when this
is not a mandatory requirement as it allows them
to demonstrate that their assessment has been
independently verified by a recognized technical
authority.

ATEX 2014/34/EU

Equipment Groups I and II,

Equipment Groups I and II, Equipment Group II,
Categories M1 and 1(*) and
Categories M2 and 2(*) Category 3
protective systems

Internal
Combustion Engine
or Electrical
Equipment?
YES NO

EU-Type EU-Type Internal Internal

Examination Examination Production Control Production Control
(Annex III) (Annex III) (Annex VIII) (Annex VIII)

AND AND

OR OR

Production Product Conformity Product Technical

Process QA Verification to Type QA File Storage at
(Annex IV) (Annex V) (Annex VI) (Annex VII) Notified Body

OR

Unit Verification (Annex IX)

* and their components and devices according to Article 1(1), if separately assessed. (Source: ATEX 2014/34/EU Guidelines, Ed. 1, European Commission).

05
 IECEx Certified Equipment

All Equipment Types

All EPLs

Test Report issued Quality Assurance Report

by ExCB AND issued by ExCB
(ExTR) (QAR)

Certificate of Conformity
issued by ExCB
(CofC)

OR

Unit Verification

06
Harmonized standards
and protective methods
To achieve conformity to the ATEX Directive the
Essential Health & Safety Requirements (EHSRs) must
be met. In practical terms, manufacturers may follow
the applicable harmonized standard(s) in order to
enable them to ‘presume conformity’ to the formal
EHSRs and proceed to place the product on the
market. While certification directly according to the
EHSRs is possible, it is more straightforward to use
harmonized standards. For IECEx the only possibility
is to follow the applicable standards.
In 2016 the harmonized standards underwent the
most significant update since the implementation of
the ATEX Directive. This update has also aligned the
approach to non-electrical equipment in both ATEX
and IECEx conformity assessment schemes.
Prior to 2016 the harmonized standards for non-
electrical equipment were the EN 13463 series which
identified both the General Requirements, applying
to all equipment, and the specific requirements for
Protective Measures available to protect against
ignition sources.
In 2016, the EN 13463 series was superseded by
adopting ISO 80079-36 and ISO 80079-37 and
including some requirements in the existing EN
60079 series of standards. The table on the next
page shows the changes and harmonized standards
available.
In addition, for non-electrical equipment there are
some addition standards which must be followed:
• EN 1127-1 Potential Mechanical and Electrical
Ignition Sources, which need to be considered
in the Ignition Hazard Assessment, and;
• The relevant Industrial Standard that would be
applicable in normal industrial applications for
the type of equipment in question. Hazardous
Area standards should therefore be viewed as
an extension of existing best practice.
07
 Harmonized standards Harmonized standards
prior to 2016 from 2016 onwards

EN 13463-1 General Requirements for all ISO/EN General Requirements for all
non-electrical equipment 80079-36 non-electrical equipment

Parts of IEC/
EN 60079-0

EN 13463-2 Protection IEC/EN Protection by

by flow 60079-2 purge and
Ex fr Ex p
restricting pressurization
enclosure

EN 13463-3 Protection by IEC/EN Protection by

flameproof Ex d 60079-1 flameproof Ex d
enclosure enclosure

EN 13463-5 Protection by ISO/EN Protection by

construction- Ex c 80079-37 construction- Ex h
al safety al safety

EN 13463-6 Protection by Protection by

control of control of
Ex b Ex h
ignition ignition
sources sources

EN 13463-8 Protection Protection

by liquid Ex k by liquid Ex h
immersion immersion

EN 1127-1 Potential Mechanical and EN 1127-1 Potential Mechanical and

Electrical Ignition Sources Electrical Ignition Sources

Various Applicable Industrial Various Applicable Industrial

Equipment Standard Equipment Standard

08
Conducting a high-quality Ignition the informative guidance in Annex B and worked
Hazard Assessment examples in Annex C. This standard contains an
An Ignition Hazard Assessment is central to excellent template which can be used for reporting.
compliance of non-electrical equipment.
Completing this exercise in comprehensive, Applying Protective Measures to achieve desired
structured and well documented manner will equipment category
enable you to ensure that the necessary level Following completion of the Ignition Hazard
of protection for the equipment is achieved. Assessment stages 1 and 2, it is very likely that a
number of ignition sources have been identified.
It is highly recommended that manufacturers follow In order to prevent the potential ignition sources
the method and structure of the Ignition Hazard becoming effective, you will need to apply
Assessment which is detailed in Clause 5 of ISO/ protective measures.
EN 80079-36 which should be viewed together with

Source: EN/ISO 80079-36 Annex

Table C.3 B Table
– Common C.3
cases pp 52
demonstrating the use of the scheme – Hot surface (1 of 2)

1 2 3 4
ignition hazard assessment of the frequency of measures applied to prevent the ignition source frequency of occurrence
occurrence without application of becoming effective incl. measures applied
an additional measure
a B a b c d e a b c a b c d e f

resulting EPL in respect of

basis
during normal operation

during normal operation

technical
during rare malfunction

during rare malfunction

necessary restrictions
No.

this ignition hazard

during foreseeable

during foreseeable

(citation of documentation
not relevant

not relevant
malfunction

malfunction

standards,
description/basic cause technical
rules, (evidence
potential (Which conditions experi- including relevant
ignition originate which ignition reasons for description of the mental features listed in
source hazard?) assessment measure applied results) column 1)

The maximum sur- – test report

– 52 –
face temperature no. …. about
under the most the thermal
adverse conditions. A type test
temperature moni- – attestation of
drive has critical
hot hot surface of a frictional toring and limiting ISO 80079- conformity and Gc
1 X heating during X T4
surface wheel drive system (ignition 37 "b" instructions of Dc
normal operation
prevention type 1; the monitoring
type of protection system (pur-
"b1") is mounted. chased from
ISO 80079-36:2016  ISO 2016

Limiting temperature an external

is 120 °C. supplier)
The bearing is
calculated according
to ISO 281 for a
specified lifetime. A
malfunction is gener-
– test report
bearing has negligi- ally agreed as a rare
hot hot surface of a ball ISO 80079- no. … about Gb
2 X ble heating during incident under these X T4
surface bearing 37 "c" the thermal Db
normal operation conditions. The
type test
maximum surface
temperature is
determined under the
most adverse condi-
tions (110 °C)

NEK ISO 80079-36:2016 provided by Standard Online AS for DNV GL Group Companies 2017-10-23

09
 Marking the Equipment for the User
Once the evaluation process is completed, you
are ready to mark the equipment. The marking
is intended to help the user of the equipment to
correctly identify the area of intended use, protection
concepts applied and critical specifications such as
surface temperature and gas or dust groups with
which it is intended to be used.
The marking is often displayed as a single line, but
is reflective of two elements: the ATEX Directive
marking (basic information on the level of explosion
protection) and the Standards marking (which
reflects the detailed parameters for the user and
maintainer of the equipment.)

Typical ATEX & IECEx Marking

Directive marking (ATEX only)

2460 II 2 G
Complies with Notified Specific Marking for Equipment Equipment Environment
the European Body Explosion Protection Group Category
Directive Number

Standards marking

Ex h IIC T4 Gb
Explosion Type of Gas group Temperature Class Equipment
protection protection (T1-T6) Protection Level

Ex tb IIIC T135°C Db
Explosion Type of protection Dust type Temperature Class (°C) Equipment
protection Protection Level

10
Documenting Compliance
- Technical Construction File (TCF)
The Technical Construction File is the critical
document to record the compliance evidence of the
equipment before it is dispatched. The manufacturer
must ensure that the TCF is stored and available
for retrieval for a period of 10 years after the last
production date for the equipment it refers to. This is
a legal requirement under ATEX for products placed
on the European market.
Depending on the category of risk, you may need
to store the TCF with a Notified Body or at the
manufacturer’s own facility, though care should be
taken as the requirements for ability to trace and
retrieve the file are the same. At DNV GL we offer
TCF storage also for non-mandatory Notified Body
storage as our physical and digital archives which
may be interest to small-medium enterprise without
an archive integrity solution of their own.
Checklist for Contents of the Technical
Construction File (TCF)
The TCF must contain the following mandatory
minimum content defined by the directive, listed
below:
■■ A general description of the equipment/product.
■■ Manufacturing drawings that describe the design of the
equipment and the protection type, if any used.
Example of report format
Standard & Clause Clause Heading
80079-36 Test for resistance to
8.3.1 impact
■■ A list of all standards applied.
■■ Assessment of the equipment for conformity: including
test data, if any, ignition hazard assessment etc.
• Ignition Hazard Assessment Document,
recommended to be presented in table format
identified in ISO EN 80079-36 Clause 5 and
Annex B.
• Clause by Clause assessment of all applied
standards is the most effective way to demonstrate
conformity, for example see below.
• Test Reports should identify test method, test
equipment including calibration data and test results.
■■ The equipment marking according to Annex II clause
1.05 of the ATEX directive and the requirements of the
standards (EN/ISO 80079-36 Clause 11).
■■ Instructions for use, in accordance with EN/ISO 80079-36
Clause 10 & ATEX Directive Annex II, Clause 1.06.
Note: While this guide focuses on Hazardous Area
Equipment compliance, be aware that for CE
marking other directives may also apply, such as
Machinery Directive, which may have additional
requirements to supplement this list.
Result / Rationale Result
The equipment was Pass
subjected to impact test
in accordance with the
method specified in EN
60079-0 clause 26.4.2.
No damage produced
such as to invalidate the
type of protection. Full
results are documented
in test report T-1234.
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 Submitting the Technical
Construction File (TCF) to a
Notified Body
DNV GL provides a number of standard services for
conformity assessment of non-electrical equipment,
detailed below:

Options Comments Price

Option 1: Single equipment Initial storage of TCF with € 1615

or batch delivery Acknowledgement of Receipt on a
specific date. Storage for 10 years.

Option 2: For serial Initial storage of TCF with validity € 2300

production date for production of identical units
for a period of 3 years.
Storage for 3 + 10 years.

Extension Renewal Fee, Extension of the Acknowledgement for € 950

if serial production every a further 3 years of serial production.
3rd year

Design Change or Additional TCF storage due to changes € 950

Modifications to the of the equipment design or
adding new equipment to the scope of
the existing acknowledgement.

Pre-assessments Assessment of the TCF to see if the € 250 per hour

documents fulfil the requirements

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SAFER, SMARTER, GREENER

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