Registered in England No. 3478646
tel: +44 1298 873800
fax: +44 1298 873801
url: www.conformance.co.uk
Great Hucklow
Derbyshire
SK17 8RG
United Kingdom
ATEX Assemblies Technical File pack - Procedure
1.
Before you begin
1.1.
The ATEX Directive
1.1.1. This guidance pack addresses compliance with the ATEX Directive
2014/34/EU only.
1.1.2. This Directive replaced the previous ATEX Directive 94/9/EC on the 20th of
April 2016.
1.2.
Mining equipment
1.2.1. This product does not apply to equipment to be used in undergrounds parts
of mines and in those parts of surface installations of such mines, liable to be
endangered by firedamp and/or combustible dust.
1.2.2. If you require an ATEX pack for this kind of product, please contact us.
1.3.
Assemblies
1.3.1. This pack is designed only for manufacturers of “assemblies of ATEX
equipment” and will not require you to involve a Notified Body (although
you may optionally choose to do so). The term “assembly of ATEX
equipment” is not defined within the text of the ATEX Directive but it is
described in the European Commission’s Guide to the ATEX Directive (§44 –
Combined equipment (assemblies)). The text of the Directive and the Guide
can be found in the folder ‘European documents’ of this ATEX ATF
(Assemblies Technical File pack) and are also available as free downloads
from the European Commission website:
http://ec.europa.eu/growth/sectors/mechanical-engineering/atex/
1.4.
Harmonised standards
1.4.1. At several points in the package, there are references to various harmonised
standards. These are subject to copyright and are available to purchase from
BSI or from any other EU member States national standards bodies.
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1.4.2. The technical state of the art is in continuous evolution: in this package we
have not indicated the issue of the standards that we have quoted (with very
few exceptions) to ensure that the information presented does not become
outdated over time.
1.4.3. If you decide to use this pack, check what is the applicable issue of the
technical standard. To do this check, please refer to the paragraph Stage 6 Select the applicable standard and list them in the Technical File.
1.5.
Other applicable directives
1.5.1. For most equipment, additional CE-marking and other directives and
regulations will also apply. You will therefore need to identify those
additional pieces of legislation in order to complete the CE-marking process
for your equipment.
1.5.2. Please be aware that by affixing the CE mark, you are indicating that the
equipment complies with all the applicable CE-marking requirements.
1.5.3. The Conformance website has pages containing useful guidance that
outlines each directive and regulation. Please contact us if you require
assistance in identifying which other pieces of legislation are relevant to your
equipment.
1.5.4. A common combination is ATEX + Machinery + EMC Directives, where the
equipment contains powered moving parts and electrical equipment.
1.5.5. Note that ATEX explicitly excludes the Low Voltage Directive.
1.5.6. Environmental directives may also be considered, e.g. RoHS, WEEE and
Ecodesign.
1.6.
Software requirements
1.6.1. The pack uses spreadsheets created in Excel, and other documents in Word.
You will need these programs (or compatible equivalents).
1.7.
Folder structures
1.7.1. This Conformance ATEX ATF pack1 includes a set of folders to assist you in
structuring the technical file.
1.7.2. The templates and checklists included in this pack are contained in the
folders.
1
ATEX ATF pack = ATEX Assemblies Technical File pack
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1.7.3. Other folders are empty and represent just a placeholder for you to arrange
your documents.
1.7.4. You are not obliged to follow this folder structure but it offers a convenient
way of ensuring that you collate all the information necessary to complete
the TF.2
1.8.
Modification of a product TF
1.8.1. You can modify and update the Technical File until you have signed the
ATEX Declaration of Conformity for the product.
1.8.2. If you modify the file, you should keep a record of the changes made and
assign a new version number. You must be able to link the serial number of
a particular product to a specific version of the file.
1.8.3. If, in the future, you want to manufacture other units that are identical to the
one described, you can still refer to the same technical file. However, you
will need to archive both the documentation received for any new
components purchased and the test reports that belong to that new serial
number.
1.8.4. If you wish to manufacture a similar, modified product (or even a series of
products), we advise you to follow all the steps of the procedure in order to
identify where updates to the TF are required.
1.8.5. For such an approach, you will need to have a system pertaining to version
control and issue dates, to ensure that you retain a copy of all the revisions
and are able to link each serial number to the correct TF version.
2
TF = Technical File
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2.
Description of the process
2.1.
This procedure and its annexes guide you through all the steps required to
demonstrate compliance of your item to the ATEX Directive, from the initial design
concept to the Declaration of Conformity, including the generation of the Technical
File.
2.2.
Each stage of this procedure will provide instructions on:
2.2.1. What documents you will need to begin;
2.2.2. What parts of the Technical File have to be written.
2.3.
Please note that detailed guidance on the contents of the Technical File and of the
templates are included in the documents of this pack.
2.4.
While you are applying this procedure, you will find several control points: use
them to check that you have correctly completed the stages.
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3.
The steps
3.1.
The diagram below shows an outline of the process. It indicates:
3.1.1. The stages involved;
3.1.2. The document that the stage will generate;
3.1.3. The checklists that have to be used to verify correctness.
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ATEX 2014/34/EU - Technical File flowchart
F_Quality Control
F1a_ATEX TF checklist
1
Create the
Technical File
A_Cover page
B_Equipment Description/
Photographs_GA
2
Describe the
equipment
F_Quality Control/
F1_PRocedures
3
Is the equipment
an assembly?
B_Equipment Description/
B2_Assembly checklist
C_ATEX Marking/
C1_ATEX Marking
5
Initial hazard
identification
6
Standard list
D_Risk Management
D5_Standard list
D_Risk Management
D6_Explosion Risk Assessment
D1_Essential Requirements cal
D2_EN1127_1_ckl / D3_Ignition Sources ckl
D4_EN13463_1 ckl / D5_Standard List
D6_Explosion risk assessment
8
Risk
Assessment
7
Design
10
ATEX parts
selection +
purchase
G_CE Marking Documentation
G1_CE Marking Mechanical and
Electrical Registrer
C_ATEX Marking
C2_Name plate guidance
12
Design name
plate
ASSEMBLY
CONFIRMATION
C_ATEX Marking
C2_Name plate/
your nameplate
E_Instructions/
E1_Warnings and Pictograms
List
E2_ATEX Addendum
13
Instructions
Manual
14
Manufacturing
+ inspection
F_Quality Control/
F1_Procedures
F1c_Instruction Manual
checklist
F_Quality Control/
F2_Records
15
NoBo
C_ATEX Marking
Optional_NoBo Certificate
C_ATEX Marking
C2_Nameplate guidance
16
Apply
Nameplate
C_ATEX Marking
C2_Nameplate
Your nameplate
C_ATEX Marking
C3_Declaration of Conformity
C3_ATEX DoC
17
Declaration of
Conformity
C_ATEX Marking
C3_Declaration of Conformity
Your DoC
18
Archive
Technical File
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F_Quality Control
F1_Procedures
(F1b_placing on the market
checklist)
F2_Records
C_ATEX Marking
B_Equipment description
BOM Bill of Materials / Calculation_modeling
Electrical drawings / Mechanical drawings / P&ID / Series
11
Reconfirm
Assembly
definition
F_Quality Control/
F1_Procedures
E_Instructions/
E1_Warnings and Pictograms
List
E2_ATEX Addendum
9
Product
description/
completion
B_Equipment Description/
B2_Assembly checklist
D_Risk Management
D1_Essential Requirements
checklist
D4_13463-1 checklist_v4
B_Equipment Description/
B1_General Description
ASSEMBLY
CONFIRMATION
4
ATEX Marking
D_Risk Management
D1_Essential Requirements checklist
D2_EN1127_1_checklist
D3_Ignition Sources checklist
D4_EN13463_1 checklist
B_Equipment Description/Client
Requirements_Environmental
Data
B_Equipment Description/
Sales Literature
ATEX
TECHNICAL FILE
Procedure
F_Quality Control/
F1_Procedures
F1a_ATEX TF Contents
checklist
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1.
Stage 1: Creating the Technical File
1.1.
Name your technical file
1.1.1. Compile the document A_Cover Page.
1.1.2. Be specific and identify what equipment and models you are going to
include in the same technical file.
1.2.
Understand what has to be included in the TF
1.2.1. This is the scope of this procedure, but if you want to have an initial
overview, you can refer to the document F1a_ATEX TF Contents checklist.
1.2.2. This document is the checklist that we will invite you to use at the end of this
procedure; this is to verify that you have included all the documents that are
required in a TF. Because of this, it is included in the folder F_Quality
Control.
1.3.
Verify the applicable legislation and guidelines
1.3.1. We keep this pack up to date with the applicable legislation as far as
possible.
1.3.2. However, before you start using this pack (and especially if you have
purchased it a long time ago), please do the following checks; contact us if
you need assistance.
Checkpoint 1 – Guidelines
Verify the most up to date issue of the ATEX Guidelines.
Search on the Internet at the following link:
http://ec.europa.eu/growth/sectors/mechanical-engineering/atex
Checkpoint 2 – Harmonised Standards
The current edition of the harmonised standard list is available on the
Internet at the following link:
http://ec.europa.eu/growth/single-market/european-standards/harmonisedstandards/equipment-explosive-atmosphere/index_en.htm
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2.
Stage 2: Describe the equipment
2.1.
A general description of the equipment opens the Technical File; our guidance
identifies what information has to be included.
2.2.
Start the process by archiving the appropriate documents in the folders as follows:
2.2.1. Equipment Description/Photographs_GA
Photographs and general assembly drawings are highly recommended.
2.2.2. Equipment Description/Sales Literature
Sales literature usually has a level of detail that is sufficient for this section.
2.2.3. Equipment Description/ Client Requirements_Environmental Data
If your client has requested special features and functions, mention these in
the general description. Also, include data (where available) regarding the
environmental conditions where the equipment is to operate.
2.3.
If your agreement with the client mentions test protocols, third party inspections,
etc., archive them in the folder: F_Quality Control/F1_Procedures.
2.4.
Analyse these documents and requirements and then complete the document
B1_General Description. In this document, there are several questions that will
guide you in putting the information that you already have in order.
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3.
Stage 3: Verify that the equipment is an Assembly
3.1.
Follow the steps outlined in the document B2_Assembly checklist and answer the
questions within it.
3.2.
To be treated as an assembly, the item has to satisfy the definition of “Assembly”
(given in the ATEX official European guidelines and reported in the ANNEX B of
this document).
3.3.
The document B2_Assembly checklist allows you to ensure that your item is a true
assembly and contains the guidance necessary to help you determine this.
3.4.
While answering to the questions of the checklist you will find it helpful to consult
Annex B of this procedure, which contains the definitions of the terminology used,
and in particular the definitions of:
3.4.1. Assemblies;
3.4.2. Hazard;
3.4.3. Risk.
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4.
Stage 4: ATEX Marking
4.1.
Compile the section “Surrounding atmosphere” of the C1_ATEX Marking
document
4.1.1. Establish the features of the surrounding atmosphere.
4.1.2. Refer to the documents in the folder ‘Client Requirements and
Environmental Data’;
or:
State what type of potentially explosive atmosphere you want your assembly
designed for.
4.1.3. Compile the section “Surrounding atmosphere”, using the ‘Guidance
questions’ provided in the C1_ATEX Marking document.
4.2.
Complete the TF section “Specific marking” of the C1_ATEX Marking document
4.2.1. You can do this if the ATEX marking is established at the beginning of the
project (e.g. by the client).
4.2.2. If you establish that ATEX marking is required at the end of the Risk
Assessment, return to this section when this procedure calls for this
document.
4.3.
Report the ATEX marking in the documents of the TF
4.3.1. In the remaining stages of this procure, you will be required to compile the
following documents:
4.3.1.1.
Instruction Manual;
4.3.1.2.
Nameplate (for affixing to the equipment);
4.3.1.3.
ATEX Declaration of Conformity;
4.3.1.4.
Annex IX – Unit Verification Product certificate(s).
4.3.2. They all contain the ATEX marking: you can include the existing ATEX
marking in all of them, but remember to update it if the risk assessment
shows you that it has to be modified.
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5.
Stage 5: Initial hazards identification
5.1.
Review the ATEX Essential Requirements checklist
5.1.1. The document D1_Essential Requirements checklist (included in the folder
‘Risk Assessment’) lists the essential requirements of the ATEX Directive.
5.1.2. We have integrated additional requirements detailed in the ATEX official
Guidelines.
5.1.3. Reviewing these requirements at an early stage of the project will reduce the
need to update the equipment design or to substitute parts that you have
purchased from others.
5.1.4. You should now be able to highlight the requirements that apply to your
equipment: write ‘A’ (Applicable) in the first column of the relevant rows.
You will fill in the remaining sections at a later stage in this process.
5.1.5. Use these requirements as guidelines while designing the product.
5.2.
Identify the potential ignition sources of the explosive atmosphere
5.2.1. If you are not familiar with the standard:
EN 1127-1 – Explosive atmospheres - Explosion prevention and protection - Part 1:
Basic concepts and methodology
please review our checklist D2_EN1127_1_checklist and considers what
clauses are applicable to your product.
5.2.2. EN 1127-1 describes what are the possible sources of ignition of a potentially
explosive atmosphere and also explains how they act during the ignition.
5.2.3. The same standard offers an overview on the key concepts to prevent these
sources becoming effective.
5.2.4. The document D3_Ignition Sources checklist lists the ignition sources that
have the potential to ignite an explosive atmosphere.
5.2.5. Use the checklists listed above to assist your choices during the design stage.
5.3.
Identify the technical measures to be applied
5.3.1. For ATEX assemblies, the standard EN 13463-1 (Non-electrical equipment for
use in potentially explosive atmospheres - Part 1: Basic method and requirements)
will help you in identifying the technical measures necessary for your
equipment.
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5.3.2. We have included the checklist for this standard in the pack: D4_EN 13463_1
checklist (based on the 2009 issue).
5.3.3. Once again, in this part of the procedure, you should identify which
requirements apply; we will return to this checklist later to check that the
requirements have been met.
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6.
Stage 6 - List the applicable standards in the Technical File
6.1.
From an ATEX point of view, an assembly only needs to comply with the technical
standard EN 13463-1.
6.2.
Other applicable Directives and Regulations may require compliance with other
standards.
6.3.
We suggest that you determine the applicable standards at this stage, before you
start the design stage.
6.4.
List of Standards
6.4.1. The technical file requires a list of technical standards that you have applied
while designing, manufacturing and testing your product.
6.4.2. We recommend that you search for harmonised standards first and then
afterwards integrate the list with other non-harmonised standards.
6.4.3. All the standards that you apply must be listed in the technical file. We have
provided you with a simple template: D5_Standard list.
6.5.
Harmonised standards
6.5.1. All CE marking Directives and Regulations have an associated list of
harmonised standards3.
6.5.2. The list of harmonised standards is published in the Official Journal of the
European Community and is updated periodically; there are no specific
dates when this takes place.
6.5.3. We have not given the editions of the standards in this guidance because the
state of the art is in continuous evolution.
6.5.4. Rather than providing you with a list of standards that may have been
withdrawn or replaced, we recommend that you identify the standards that
you have used by means of their issue number. If you unsure of the standard
or its issue number and date, please contact us.
Harmonised standards - When a standard is accepted by the European Commission and it is referenced in
their Official Journal, it is considered harmonised to the referenced directive. It is a mandatory requirement
that the essential requirements of a directive are to be met. However, by using a harmonised standard (as
opposed to standards that are not harmonised), there is a presumption of conformity that the essential
requirements of the associated directive have been met by the full compliance of that harmonised standard.
3
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6.5.5. The list of the ATEX harmonised standards is available at this link to the
official European Community website
http://ec.europa.eu/growth/single-market/european-standards/harmonisedstandards/equipment-explosive-atmosphere/index_en.htm
6.5.6. Should this link have expired, the list of harmonised standards can be
retrieved by searching for the following terms
ec.europa.eu – ATEX – standardisation
6.6.
Other standards
6.7.
You may apply other standards than those that have been harmonised.
6.8.
Furthermore, you can refer to other guidance documents, (for instance, those issued
by manufacturers and manufacturing associations, etc.) and to contractual
specifications.
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7.
Stage 7 and Stage 8: Design and Risk Assessment
7.1.
Iterative process: compile the D6_Explosion Risk Assessment while designing
the assembly
7.1.1. We recommend that you:
7.1.1.1.
Design the product (basing the design on the preliminary hazards
and technical measures that you have previously identified); and
7.1.1.2.
Continuously update the design, in conjunction with the risk
assessment in an iterative manner, to obtain a suitable design.
7.1.2. For instance:
7.2.
7.1.2.1.
If you note a new risk while you are compiling the risk
assessment, and identify that this can be mitigated/removed using
a different design, you must modify the design;
7.1.2.2.
If you add or remove a feature while designing the equipment and
this has an effect (whether positive or negative) on the risk
assessment, you must update the risk value accordingly.
Alternative method: compile the D6_Explosion Risk Assessment, once your
design is completed
7.2.1. Instead of using the iterative method, you might find it more convenient and
useful to compile the Explosion Risk Assessment once you have completed
the design stage.
7.2.2. This is your personal choice and depends on how you prefer to perform the
task.
7.3.
Other directives and regulations
7.3.1. If the product falls within the scope of other directives and regulations, other
risk assessments are required; you can store the additional risk assessments
in the same folder.
7.4.
Final outcomes of the Stages 7: Design and 8: Explosion Risk Assessment
7.4.1. Complete the Risk assessment folder
7.4.1.1.
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Update the D1_Essential Requirements checklist: verify that all
of the applicable requirements have been satisfied and record this
in the columns provided.
Procedure
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7.4.1.2.
Update the D2_EN1127_1_checklist and the D3_Ignition sources
checklist: verify that all the potential ignition sources have been
managed and that they are not capable of igniting the potential
atmosphere in the conditions specified by the equipment category.
7.4.1.3.
Update the D4_EN 13463_1 checklist: verify that the applicable
requirements have been satisfied and record this accordingly.
7.4.1.4.
Review the D5_Standard List and update if necessary.
7.4.1.5.
Update the D6_Explosion Risk Assessment.
7.4.2. Write the E1_Warnings and Pictograms List
7.4.2.1.
For some hazards, you may have determined that the only
reasonable, preventative or mitigating measure that can be
employed is to ensure that the final user is aware of these hazards
and knows how to deal with them.
7.4.2.2.
Such measures may require warnings and pictograms to be
marked on the equipment.
7.4.2.3.
NOTE: the markings must be reproduced (and explained) in the
instruction manual.
7.4.3. Write the Safety Warning section of your Instruction Manual
7.4.3.1.
The E2_ATEX Addendum provides instructions for safe use of the
equipment that are not described by mean of a pictogram or a
short warning.
7.4.3.2.
For instance, in this section you can specify that installation must
be performed by electricians that are competent at installing
equipment in hazardous areas.
7.4.4. Update the folder C_ATEX marking
7.4.4.1.
If the ATEX classification has changed as a result of the risk
assessment or other procedures, you should review and update
C1_ATEX Marking and other documents listed in § 4.3.1.
7.4.4.2.
Ensure that all the documents of the folder are kept up-to-date.
7.4.5. Quality control: tests procedures and checklists
7.4.5.1.
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The Risk Assessment exercise will identify specific features that
are required in order for the equipment to be used safely.
Procedure
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7.4.5.2.
To prevent the equipment being placed on the market without
these features in place, it must undergo inspection and testing.
7.4.5.2.1. For example, all parts shall have the same electrical
potential. This can be checked by an equipotential test
conducted on the machine. A record of the test shall be
archived in the equipment technical file (EN 60079-14 § 6.4,
Potential equalisation).
7.4.5.3.
All such actions that are performed to verify that your equipment
complies with its design and with the ATEX Directive shall be
described in the sub-folder F1_Procedures of the F_Quality
Control folder.
7.4.5.4.
While compiling the Risk Assessment, gather any results from
tests and inspections performed and include these documents in
the folder F_Quality Control/F2_Records. In addition to your own
tests, you can also collect the test procedures required by the client
in this folder (e.g. witnessed tests).
7.4.5.5.
In the Conformance ATEX ATF pack, we have suggested some
control points that represent the very last checks that you have to
do, before placing the equipment on the market: F1b_placing on
the market checklist.
7.4.5.6.
This is a general guidance pack and so cannot provide specific
information on your particular equipment.
7.4.5.7.
Please contact us if you require further advice.
7.4.6. Quality control: procedures for tests and checks that are not relevant to
ATEX
8.
7.4.6.1.
You do not need to include the results of non-ATEX related quality
control procedures in the ATEX Technical File.
7.4.6.2.
However, if other Directives apply to your equipment, it may be
more convenient for you to archive all the procedures and results
together, without selecting what is pertinent to ATEX and what is
not. There is no mandatory approach to how you organise your
documents.
VOID
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Procedure
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9.
Stage 9 - Complete the product description
9.1.
Once the design is finalised, you should update the equipment description where
necessary.
9.2.
How you store your documents is entirely up to you, but we have provided the
folder B_Equipment description and associated subfolders for this purpose:
9.2.1. B6_BOM Bill Of Material
9.2.2. B7_Calculation_modelling
9.2.3. B8_Electrical drawings
9.2.4. B9_Mechanical drawings
9.2.5. B10_P&ID
9.2.6. B11_Series4
9.3.
Level of detail to be included in the Technical File B_Equipment description
9.3.1. The set of documents given in the Technical File shall be sufficient for an
enforcement authority to verify that the equipment has been designed and
manufactured according to the Essential Health and Safety Requirements of
the ATEX Directive (and of other directives and regulations, where relevant).
9.3.2. It might be more convenient for you to include all the details of your design
in the Technical File, rather than just a selection of documents.
9.3.3. The Technical File can only be demanded by an enforcement authority (the
HSE in the UK, for example) and therefore its content will not be available to
anyone else.
9.3.4. Exceptions to this rule include:
9.3.4.1.
You have a commercial contract with the client that requires you
to provide him with a copy of the Technical File;
9.3.4.2.
You are involving a Notified Body, on a voluntary basis, because
you want the equipment to be certified (refer to the optional step
15 of the procedure included in this procedure).
The contents of this folder should uniquely identify each piece of equipment in the series (e.g. by model
number) and provide a brief description of each.
4
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Procedure
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9.4.
Series of equipment
9.4.1. In the case of a series of equipment, all the types included in the series must
be described.
9.4.2. You may find it useful to describe all of the common features of the
equipment and have a separate section detailing all the variants.
9.4.3. We do not recommend issuing a new Technical File for each new piece of
equipment (unless the modifications are significant), so as to avoid
unnecessary duplication of documentation. However, you are free to choose
whatever grouping of products and files you find most convenient.
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10.
Stage 10 – Selection and purchasing of ATEX rated equipment
10.1. During the design, you may have decided to use 3rd-party components as part of
your assembly.
10.2. You should verify that these components are already CE marked to all of their
applicable directives and regulations.
10.3. For the CE ATEX marked parts, you should specify the relevant requirements of the
equipment before placing your order. Considerations include:
10.3.1. ATEX category;
10.3.2. Gas or Dust;
10.3.3. Gas or Dust group;
10.3.4. Protective method (if you have received specific requirements from your
clients or if you have preferences);
10.3.5. Maximum surface temperature;
10.3.6. Range of ambient temperature;
10.4. You can list all these requirements in the G1_CE marking Mechanical and
Electrical Register.
10.5. Other CE Marking Directives and Regulations might be applicable but this
procedure applies to ATEX only. You can include those others requirements in the
document G1_CE marking Mechanical and Electrical Register.
10.6. Inspect the items and the CE marking documentation that you receive
10.6.1. All the ATEX rated parts must be supplied accompanied by the mandatory
CE marking documentation:
10.6.1.1.
Name plate;
10.6.1.2.
Instruction manual;
10.6.1.3.
Declaration of Conformity.
10.7. Regarding the requirements for the language used for instructions manual and
declaration of conformity, your suppliers must satisfy the obligations of the ATEX
Directive as reported in:
10.7.1. Article 6 – parts 7 and 8;
10.7.2. Article 14 – part 2.
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10.8. The same requirements apply to all applicable CE marking Directives and
Regulations applicable to the purchased CE marked parts.
10.9. You can keep track of any missing documentation using the document G1_CE
marking Mechanical and Electrical Register as a checklist.
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11.
Stage 11: Reconfirm that the equipment is an Assembly
11.1. You should now confirm that your initial assumption that the term ‘Assembly’ is
still applicable, according to the CE marking documentation that you have
collected.
11.2. You can achieve this by reviewing the checklist that you previously compiled in
Stage 3. If you can confirm that the definition of Assembly still applies, you can
move to stage 12.
11.3. If the equipment no longer matches the assembly definition and you unable to
generate a suitable solution, please contact us. A more stringent ATEX Directive
procedure might be needed, but we may be able to suggest alternative solutions.
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12.
Stage 12: Design the ATEX nameplate
12.1. If all of the purchased CE ATEX rated pieces of equipment bear the appropriate
ATEX markings, your assembly meets the ATEX marking specification that you
compiled in the document C1_ATEX marking.
12.2. At this point you can create the ATEX nameplate. In the document C2_Name plate
guidance we have stated the information that is required to be included on an
ATEX assembly nameplate.
12.3. Other CE Directives and Regulations may apply; if so, the nameplate might be
required to bear other information. Refer to those Directives and Regulations for
their specific requirements.
12.4. Once your nameplate drawing is completed, store the drawing in the folder
C2_Nameplate.
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13.
Stage 13: Complete and review the instruction manual
13.1. In this package, we have included the folder E_Instructions to help you complete
your ‘Instruction manual’.
13.2. In the folder, there are two documents: E1_List of Warnings and Pictograms (that
you have already completed as an outcome of your risk assessment) and E2_ATEX
addendum.
13.3. E2_ATEX addendum contains the information that must appear in an ATEX
instruction manual. You can use this document both as guidance and as a checklist.
13.4. In this stage we have included a control point. The ATEX manual checklist
(F1c_Instruction Manual checklist) contains both mandatory requirements and
requirements recommended as good practice.
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14.
Stage 14: Manufacturing and final inspection
14.1. While installing ATEX rated components, always follow the instructions in the
suppliers’ instruction manuals.
14.2. Furthermore, during the manufacture, always apply the rules for installation as
included in:
EN 60079-14 - Explosive atmospheres. Electrical installations design, selection and erection
14.3. In case of doubt, involve a qualified and competent electrical company to assist you
with your manufacturing or assembly process.
14.4. An ‘Operators CompEx’ training certificate is not a mandatory requirement for an
electricial engineer to undertake this task.
14.5. Inspect the product. This is a control point and it is required that you perform all
the tests that you have included in the sub-folder F_Quality Control/
F1_Procedures.
14.5.1. On completion, archive all of your Quality Control records in the
appropriate folder F2_Records.
14.5.2. D1_Essential Requirements checklist. It is considered beneficial at this
stage to revisit and review the ATEX Essential Requirements checklist.
14.6. Review of the requirements of the applied standard: It is also recommended, at
this stage, that the equipment is re-assessed against the requirements of the
applicable standards.
14.6.1. Performing a review on the completed item, using the methods that have
been previously described in this procedure will provide reassurance that
you conform to the applied standard. This considered good practice and is
particularly useful in case of harmonised standards.
14.6.2. In the folder D_Risk Management, we have included the D4_EN 13463-1
checklist that is applicable to any ATEX assembly. You should have already
reviewed this checklist during the earliest stages of this procedure. A further
review is recommend at this stage.
14.6.3. If you have applied other standards (relevant to other directives) we can
provide you with checklists to these. Please contact us if these are required.
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15.
Stage 15: OPTIONAL – Require the inspection of a Notified Body
15.1. If you are not required to involve a Notified Body, continue to Stage 16.
15.2. You are not required to involve a Notified Body if your equipment meets the
definition of an ‘Assembly’ (see § 3 & 11), although may still wish to use one if you
so wish. In using a Notified Body you will be utilising the procedure described in
Annex IX - MODULE G: Conformity based on Unit Verification of the ATEX
Directive.
15.3. An Annex IX Certificate might also be a contractual requirement specified by your
client.
15.4. This type of certificate specifies the exact serial number of the equipment inspected.
It is also possible to group multiple serial numbers and have them all inspected and
certified at the same time.
15.5. Please note that the Notified Body will also inspect the equipment’s Technical File.
15.6. Conformance can offer you assistance with the Notified Body process.
15.7. You should store any Annex IX certificates issued in the folder Optional_NoBo
Certificate (subfolder of C_ATEX Marking).
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16.
Stage 16: CE mark the finished equipment
16.1. Drawing up of the name plate
16.1.1. Review the required nameplate content (C2_Name plate guidance in the
folder C_ATEX marking) and, update the drawing if required.
16.1.2. Again, please bear in mind that this package refers to the ATEX Directive
only. Other information may be required according to other Directives and
you should refer to those for their particular requirements.
16.2. Apply the nameplate
16.2.1. No mandatory nameplate material is specified, but it must be legible and
durable and be able to withstand the environment where the equipment is
intended to be used. It must be sufficiently durable to last for the foreseeable
lifetime of the equipment.
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17.
Stage 17: Draw up and sign the Declaration of Conformity
17.1. In the Conformance ATEX ATF pack we have included the template
C3_Declaration of Conformity.
17.2. Other Directives and Regulations may be applicable and have to be listed on the
Declaration of Conformity, according to the minimum requirements set by these
pieces of legislation.
17.3. The Declaration of Conformity shall be signed by a person empowered to make
legally binding decisions on behalf of the manufacturer.
17.4. Another way of looking at this is that the person signing is responsible for
providing the resources required to ensure that the product is safe.
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18.
Stage 18: Complete and store the Technical File
18.1. This is a control point. The document F1a_ATEX TF Contents checklist lists all the
documents that you have to include in the Technical File (as we have outlined in
the first stage of this procedure). Reviewing this checklist will identify any potential
missing items in the Technical File that you have created.
18.2. Once you have completed the Technical File, securely store it (include the
Instruction Manual and the CE Declaration of Conformity) for at least 10 years after
the date you cease the production of the equipment.
18.3. The structure of the ATEX Technical File that we have provided is suitable to be
stored in its current layout.
18.4. You should ensure that the IT format that you choose will still be readable 10 years
after you cease production. This is particularly important for CAD drawings which
often require specialist software to read.
You could also prefer to print a hard copy of the Technical File. In this case, we
recommend that you add a revision number and an issue date to all the documents
included in the TF.
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ANNEX A – Bibliography - Update: 19 April 2016
Legislation
•
DIRECTIVE 2014/34/EU OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL of 26 February 2014 on the harmonisation of the laws of the Member States
relating to equipment and protective systems intended for use in potentially explosive
atmospheres (recast) - (Text with EEA relevance).
•
National transpositions of the above mentioned directive.
European Official Guidelines
•
Guide to application of the Directive 2014/34/EU of the European Parliament and of the
Council of 26 February 2014 on the harmonisation of the law of the Member States
relating to Equipment and Protective Systems intended for use in Potentially Explosive
Atmospheres – 1st edition, April 2016.
Harmonised Standards
•
EN 1127-1:2011 – Explosive atmospheres - Explosion prevention and protection - Part 1: Basic
concepts and methodology
•
EN 13463-1:2009 – Non-electrical equipment for use in potentially explosive atmospheres Part 1: Basic method and requirements
•
EN 13463-5:2011 – Non-electrical equipment intended for use in potentially explosive
atmospheres - Part 5: Protection by constructional safety ‘c'
•
EN 15198:2007 – Methodology for the risk assessment of non-electrical equipment and
components for intended use in potentially explosive atmospheres
•
EN 60079-0:2012 – Explosive atmospheres - Part 0: Equipment - General requirements
•
EN 60079-1:2014 – Explosive atmospheres - Part 1: Equipment protection by flameproof
enclosures "d"
•
EN 60079-11:2012 – Explosive atmospheres - Part 11: Equipment protection by intrinsic safety
"i"
•
EN 60079-20-1:2010 – Explosive atmospheres - Part 20-1: Material characteristics for gas and
vapour classification - Test methods and data
Non-harmonised standards
•
EN 60079-14:2014 – Explosive atmospheres. Electrical installations design, selection and
erection
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ANNEX B – Definitions (Updated 19 April 2016)
Assemblies
The definition of assembly is taken with no modification from the Official ATEX 2014/34/EU
Guidelines – 1st edition, April 2016.
§ 44 Combined equipment (assemblies)
From the term "jointly" in the definition of equipment in the Directive (Article 2(1)) it follows that a
product, formed by combining two or more pieces of equipment, together with components if
necessary and together with other parts as necessary, that are electrically and mechanically
interconnected to create a complete functional assembly, has to be considered as a product falling
under the scope of Directive 2014/34/EU. This combined product or assembly must be placed on
the market and/or put into service by a responsible person (who will then be the manufacturer of
that assembly) as a single functional unit.
Such assemblies may not be ready for use but require proper installation. The instructions (Annex
II, 1.0.6.) shall take this into account in such a way that compliance with Directive 2014/34/EU is
ensured without any further conformity assessment provided the installer has correctly followed
the instructions.
In the case of an assembly consisting of different compliant pieces of equipment as defined by
Directive 2014/34/EU which were previously placed on the market by different manufacturers
these items of equipment have to conform with the Directive, including being subject to proper
conformity assessment, CE-marking, etc. The manufacturer of the assembly may presume
conformity of these pieces of equipment and may restrict his own risk assessment of the assembly
to those additional ignition and other relevant hazards (as defined in Annex II) which become
relevant because of the final combination. If there are additional ignition hazards, a further
conformity assessment of the assembly regarding these additional risks is necessary. Likewise, the
assembler may presume the conformity of components which are accompanied by a written
attestation of conformity issued by their manufacturer (Article 6(2)) (see also section § 74 on
obligations of manufacturers).
However, if the manufacturer of the assembly integrates parts without CE marking into the
assembly (because they are parts manufactured by himself or parts he has received from his
supplier in view of further processing by himself) or components not accompanied by the written
attestation of conformity, he shall not presume conformity of those parts and his conformity
assessment of the assembly shall cover those parts as required.
Note that the manufacturer's own risk assessment does not necessarily preclude the use of notified
bodies in the applicable conformity assessment procedure(s).
In order to clarify the concept of "assembly" in the sense of Directive, a pump/electric motor
combination intended for use in potentially explosive atmospheres can be used as an example.
1. For the purposes of Directive 2014/34/EU, a split tube motor pump constitutes a single item of
equipment with respect to the ignition hazard, i.e. the pump and electric motor cannot be
considered separately for the purposes of assessing explosion risk(s). In this case, the unit as a
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whole has to undergo the conformity assessment procedure of electrical equipment. The same
applies e.g. for an electrical ventilating fan where the fan is an integral part of the motor.
2.a) In some cases the pump and electric motor can be considered separately although they form a
functional unit. If in this case there is no additional ignition hazard as a result of assembling
the pump and motor, this functional unit as a whole does not constitute a single item of
equipment which falls within the scope of Directive 2014/34/EU. It is then to be considered a
combination of "individual items of equipment" in terms of explosion protection. In this case,
therefore, the manufacturer of pump and electrical motor must supply an EU declaration of
conformity for each of both items.
2.b)A manufacturer may nevertheless choose to supply pump and motor as described in 2. a) with
one EU declaration of conformity for the assembly as a whole. In this case further clarification
is required as to the obligation of the assembler where only ATEX compliant products (such as
equipment and autonomous protective systems) are used. Here it is clear that the assembler
needs to undertake an ignition risk assessment to ensure that the nature of the incorporation
and assembly has not altered the explosion characteristics of the products with respect to the
essential health and safety requirements of the Directive. If the assembler is in any way
uncertain as to how to undertake such an assessment, technical advice should be sought and
taken into account. This might be the case, for example, if a manufacturer of mechanical
equipment needs to connect different pieces of ATEX electrical equipment together as part of
the assembly. Once the assembler has successfully undertaken such an assessment and no
additional ignition risk has been identified, the general agreement is that he then draws up a
technical file, affixes the CE and ex marking according to Annex II 1.0.5 of the Directive to the
assembly, indicating intended use, signs the EU declaration of conformity covering the whole
of the assembly indicating the technical specifications/ standards applied (for example, for
electrical inter-connection) and provide instructions for safe use. The assembler therefore takes
complete responsibility for the assembly. This procedure does not require the involvement of a
notified body.
2.c) If there is an additional ignition hazard as a result of assembling pump and motor, or if one
item is not already in full conformity with the Directive, the assembly has to undergo the
complete conformity assessment procedure appropriate for the category.
Assemblies may be placed on the market in different ways: with specified configurations of parts
or with various configurations.
Combined products (assemblies) which are fully specified configurations of parts
In this case the manufacturer has already defined one or more invariable combination(s) of parts
and places them on the market as a single functional unit / single functional units.
An example could be instrumentation consisting of a sensor, a transmitter, a Zener barrier and a
power supply if provided by one manufacturer.
The above mentioned parts are put together by the same person (the manufacturer of the
assembly), and placed on the market as a single functional unit. This person assumes
responsibility for the compliance of the combined product with the Directive.
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The EU declaration of conformity, as well as the instructions for use must refer to the assembly as
a whole. It must be clear (e.g. by enclosing a list of all parts and/or a list of the safety related data)
which is/are the combination(s) that form(s) the assemblies. The manufacturer assumes
responsibility for compliance with the Directive, and must therefore, in accordance with Annex II
1.0.6, provide clear instructions for assembly/installation/operation/maintenance etc. in the
instructions for use.
Combined products (assemblies) with various configurations
In this case the manufacturer has defined a whole range of different parts, forming a "modular
system". Either he or the user/installer selects and combines parts out of this range to form an
assembly, which serves the specific task.
An example could be a modular system for flameproof switch- and control gear, consisting of a
range of flameproof enclosures of different size, a range of switches, terminals, circuit breakers etc.
Although in this case the parts are not necessarily put together by the manufacturer of the
assembly, and placed on the market as a single functional unit, the manufacturer is responsible for
the compliance of the assembly as long as the parts are chosen from the defined range and selected
and combined according to his instructions.
The EU declaration of conformity, as well as the instructions for use must refer to the "modular
system" as a whole. It must be clear which the parts that form the modular system are, and how
they are to be selected to form a compliant assembly. Therefore the manufacturer must, in
accordance with Annex II 1.0.6, provide clear instructions for selection of parts and their
assembly/installation /operation/maintenance etc. in the instructions for use. The conformity
assessment of such modular systems may be done (as a minimum) by means of the assessment of
those intended configurations which are the most unfavourable regarding the relevant risks (worst
cases). If those configurations are considered compliant to the essential health and safety
requirements of Directive 2014/34/EU the manufacturer may conclude conformity of all other
intended configurations as well. If later on other parts are to be added to the "modular system" it
may of course become necessary to identify and assess the worst case scenario again.
The Table 1: Summary of requirements for combined products (assemblies), on the following page,
gives a condensed overview of the various situations regarding assemblies and their requirements
under the ATEX Directive 2014/34/EU.
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Table 1: Summary of requirements for combined products (assemblies) under the ATEX
Directive 2014/34/EU
SITUATION: 1.
Parts: Assembly
is composed of...
Equipment, protective systems, devices (Article 1(1))
all CE-marked (accompanied by an EU declaration of
conformity) and components accompanied by a
written attestation of conformity (Article 13(3)) (parts
with proven conformity) (*)
Equipment, protective systems, devices (Article 1(1)),
including non CE- marked, and components not
accompanied by a written attestation of conformity
(Article 13(3))
(parts without proven conformity)
2.
Configuration:
Assembly is
placed on the
market as...
Exactly defined
configuration(s)
A "modular system" of
parts, to be specifically
selected and configured
to serve a specific
purpose, maybe by the
user/installer.
Exactly defined
configuration(s)
A "modular system" of
parts, to be specifically
selected and configured
to serve a specific
purpose, maybe by the
user/installer.
3. RESULT:
Manufacturer
may presume
conformity for...
All parts
All parts
Only parts with proven
conformity
Only parts with proven
conformity
4. Conformity
assessment
Conformity assessment
has to cover the whole
configuration regarding
all risks, which might
arise by the interaction of
the combined parts, with
respect to the intended
use.
Conformity assessment
has to cover at least those
of the possible and useful
configurations, which are
assessed to be the most
unfavourable regarding
all risks, which might
arise, by the interaction
of the combined parts,
with respect to the
intended use.
Conformity assessment
has to cover:
Conformity assessment
has to cover:
- all parts without proven
conformity regarding all
risks, and
- all parts without proven
conformity which are part
of the "modular system",
regarding all risks, and
See also Note (*)
See also Note (*)
5. Information to
be provided:
a) by EU
declaration of
conformity
b) by
instructions for
installation and
use
- all configuration(s)
regarding all risks which
might arise by the
interaction of the
combined parts, both
with respect to the
intended use.
- at least those of the
possible and useful
configurations, which are
assessed to be the most
unfavourable regarding
all risks which might
arise by the interaction of
the combined parts, both
with respect to the
intended use.
a) identification of the
items in the assembly that
are ATEX equipment in
their own right, and
which have been
separately assessed;
a) identification of the
items in the "modular
system" that are ATEX
equipment in their own
right, and which have
been separately assessed;
a) identification of the
items in the assembly that
are ATEX equipment in
their own right, and
which have been
separately assessed;
a) identification of the
items in the "modular
system" that are ATEX
equipment in their own
right, and which have
been separately assessed;
b) instructions for
installation and use,
sufficient to ensure that
resulting assembly
complies with all relevant
EHSRs of Directive
2014/34/EU.
b) instructions for the
selection of parts, to be
combined to fulfil the
required purpose, and
instructions for
installation and use,
sufficient to ensure that
resulting assembly
complies with all
relevant EHSRs of
Directive 2014/34/EU.
b) instructions for
installation and use,
sufficient to ensure that
resulting assembly
complies with all relevant
EHSRs of Directive
2014/34/EU.
b) instructions for the
selection of parts, to be
combined to fulfil the
required purpose, and
instructions for
installation and use,
sufficient to ensure that
resulting assembly
complies with all relevant
EHSRs of Directive
2014/34/EU.
(*) Note: A written attestation of conformity for a component cannot guarantee, in general, the safety of the
equipment into which the component is to be incorporated, as for a component, all possible use cannot be
foreseen. In this case, further investigation and evaluation by a notified body shall be carried out in the
assembly, when required.
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Simple Apparatus (as described in EN 60079-11)
“Electrical component or combination of components of simple construction with well-defined electrical
parameters and which is compatible with the intrinsic safety of the circuit in which it is used”
The following are considered “simple apparatus”:
a) Passive components, e.g. switches, junction boxes, resistors and simple semiconductor devices;
b) Sources of stored energy consisting of single components in simple circuits with well- defined
parameters, e.g. capacitors or inductors, whose values shall be considered when determining
the overall safety of the system;
c) Sources of generated energy, for example thermocouples and photocells, which do not
generate more than 1.5 V, 100 mA and 25 mW.
Simple apparatus shall conform to all relevant requirements of EN 60079-11 with the exception of §
12 (marking). The manufacturer or intrinsically safe system designer shall demonstrate
compliance with these requirements, including material data sheets and test reports, if applicable.
The following points must be considered:
1. Simple apparatus must not achieve safety by the inclusion of voltage and/or current-limiting
and/or suppression devices;
2. Simple apparatus must not contain any means of increasing the available voltage or current
(e.g. DC-DC converters);
3. Where it is necessary that the simple apparatus maintains the integrity of the isolation from
earth of the intrinsically safe circuit, it must meet § 6.3.13 (dielectric strength) and § 6.2.1
(terminals) of EN 60079-11;
4. Non-metallic enclosures and enclosures containing light metals when located in the explosive
atmosphere shall conform to the electrostatic charges on external non-metallic materials
requirements and metallic enclosures and parts of enclosures requirements of IEC 60079-0;
5. When simple apparatus is located in the explosive atmosphere, the maximum surface
temperature shall be assessed. When used in an intrinsically safe circuit within their normal
rating and at a maximum ambient temperature of 40 °C, switches, plugs, sockets and terminals
will have a maximum surface temperature of less than 85 °C, so they can be allocated a T6
temperature classification for Group II applications and are also suitable for Group I and
Group III applications. For other types of simple apparatus the maximum temperature shall be
assessed in accordance with 5.6 of EN 60079-11.
Where simple apparatus forms part of an apparatus containing other electrical circuits, the whole
shall be assessed according to the requirements of EN 60079-11.
NOTE 1 Sensors which utilize catalytic reaction or other electro-chemical mechanisms are not
normally simple apparatus. Specialist advice on their application should be sought.
NOTE 2 It is not a requirement of EN 60079-11 that the conformity of the manufacturer’s
specification of the simple apparatus needs to be verified.
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Hazard & Risk (as described in EN ISO 12100 – Safety of machinery - General principles for
design - Risk assessment and risk reduction)
Hazard: potential source of harm
NOTE 1 The term “hazard” can be qualified in order to define its origin (for example, mechanical
hazard, electrical hazard) or the nature of the potential harm (for example, electric shock
hazard, cutting hazard, toxic hazard, fire hazard).
NOTE 2 The hazard envisaged by this definition either:
•
is permanently present during the intended use of the machine (for example, motion
of hazardous moving elements, electric arc during a welding phase, unhealthy
posture, noise emission, high temperature), or
•
can appear unexpectedly (for example, explosion, crushing hazard as a consequence
of an unintended/unexpected start-up, ejection as a consequence of a breakage, fall
as a consequence of acceleration/deceleration).
NOTE 3 The French term “phénomène dangereux” should not be confused with the term
“risque”, which was sometimes used instead in the past.
Risk: The combination of the probability of occurrence of harm and the severity of that harm.
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ANNEX C – ATEX marking codes (Updated 19 April 2016)
Gas groups
Gas Group Code
Typical example
IIA
Propane
IIB
Ethylene
IIC
Hydrogen
Equipment marked IIB is suitable for applications requiring Group IIA equipment. Similarly,
equipment marked IIC is suitable for applications requiring Group IIA or Group IIB equipment.
The gas group of the most common gas and vapours can be found in the standard EN 60079-20-1:
2010.
The classification is defined according to the responses to tests (the procedure is explained in the
standard EN 60079-1: 20014 (Explosive atmospheres. Equipment protection by flameproof
enclosures "d")
Dust groups
Dust Group Code
Description
IIIA
Combustible flyings
IIIB
Non-conductive dust
IIIC
Conductive dust
Equipment marked IIIB is suitable for applications requiring Group IIIA equipment. Similarly,
equipment marked IIIC is suitable for applications requiring Group IIIA or Group IIIB equipment.
Extensive information on the explosive dust classification is available at:
GESTIS-DUST-EX (Database Combustion and explosion characteristics of dusts):
http://www.dguv.de/ifa/Gefahrstoffdatenbanken/GESTIS-STAUB-EX/index-2.jsp
Auto ignition temperature (Ti) (EN 13237)
Lowest temperature (of a hot surface) at which under specified test conditions an ignition of a
flammable gas or flammable vapour in mixture with air or air/inert gas occurs
Minimum ignition temperature of a dust cloud (EN 13237)
Lowest temperature of a hot surface on which the most ignitable mixture of the dust with air is
ignited under specified test conditions
Minimum ignition temperature of a dust layer (EN 13237)
Lowest temperature of a hot surface at which ignition occurs in a dust layer under specified test
conditions
Flash-point of the flammable material (EN 13237)
Lowest liquid temperature at which, under certain standardised conditions, a liquid gives off
vapours in a quantity such as to be capable of forming an ignitable vapour/air mixture
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Temperature class of the equipment for explosive atmospheres due to GAS (EN 13463-1)
Classification of maximum surface temperatures for Group IIG equipment:
Temperature class
Maximum surface
temperature (°C)
T1
450
T2
300
T3
200
T4
135
T5
100
T6
85
Where the maximum surface temperature depends not on the equipment itself, but mainly on
operating conditions (like a heated fluid in a pump), the relevant information shall be given in the
instructions for use and the equipment shall be marked with TX in order to inform the user about
this special situation (see Clause 9 on marking).
Temperature class of the equipment for explosive atmospheres due to DUST (13463-1)
Group IID equipment shall be defined by the actual maximum surface temperature and shall be
marked accordingly (e.g. T150°C).
Definition of groups and categories
We recommend that you refer to the text of the ATEX Directive (2014/34/EU, Annex I) for a
complete understanding of the meaning of groups and categories.
Here, we have provided you with a summary of the meaning of these terms.
Equipment group I
Applies to equipment intended for use in underground parts of mines, and in those parts of
surface installations of such mines, liable to be endangered by firedamp and/or combustible dust.
Equipment-group I Category M 1
comprises equipment designed and, where necessary, equipped with additional special means
of protection to be capable of functioning in conformity with the operational parameters
established by the manufacturer and ensuring a very high level of protection.
Equipment in this category is intended for use in underground parts of mines as well as those
parts of surface installations of such mines endangered by firedamp and/or combustible dust.
Equipment in this category is required to remain functional, even in the event of rare incidents
relating to equipment, with an explosive atmosphere present, and is characterised by means of
protection such that:
-
either, in the event of failure of one means of protection, at least an independent second
means provides the requisite level of protection,
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-
or the requisite level of protection is assured in the event of two faults occurring
independently of each other.
Equipment-group I Category M 2
comprises equipment designed to be capable of functioning in conformity with the operational
parameters established by the manufacturer and ensuring a high level of protection.
Equipment in this category is intended for use in underground parts of mines as well as those
parts of surface installations of such mines likely to be endangered by firedamp and/or
combustible dust.
This equipment is intended to be de-energised in the event of an explosive atmosphere.
The means of protection relating to equipment in this category assure the requisite level of
protection during normal operation and also in the case of more severe operating conditions, in
particular those arising from rough handling and changing environmental conditions.
Equipment group II
Applies to equipment intended for use in other places liable to be endangered by explosive
atmospheres.
Equipment-group II Category 1
Category 1 comprises equipment designed to be capable of functioning in conformity with the
operational parameters established by the manufacturer and ensuring a very high level of
protection.
Equipment in this category is intended for use in areas in which explosive atmospheres caused
by mixtures of air and gases, vapours or mists or by air/dust mixtures are present
continuously, for long periods or frequently.
Equipment in this category must ensure the requisite level of protection, even in the event of
rare incidents relating to equipment, and is characterized by means of protection such that:
-
either, in the event of failure of one means of protection, at least an independent second
means provides the requisite level of protection;
-
or the requisite level of protection is assured in the event of two faults occurring
independently of each other.
Equipment-group II Category 2
Equipment category 2 comprises equipment designed to be capable of functioning in
conformity with the operational parameters established by the manufacturer and of ensuring a
high level of protection.
Equipment in this category is intended for use in areas in which explosive atmospheres caused
by gases, vapours, mists or air/dust mixtures are likely to occur occasionally.
The means of protection relating to equipment in this category ensure the requisite level of
protection, even in the event of frequently occurring disturbances or equipment faults which
normally have to be taken into account.
6547/16D0601
Annex C
Page 39 of 41
Equipment-group II Category 3
Category 3 comprises equipment designed to be capable of functioning in conformity with the
operating parameters established by the manufacturer and ensuring a normal level of
protection.
Equipment in this category is intended for use in areas in which explosive atmospheres caused
by gases, vapours, mists, or air/dust mixtures are unlikely to occur or, if they do occur, are
likely to do so only infrequently and for a short period only.
Equipment in this category ensures the requisite level of protection during normal operation.
6547/16D0601
Annex C
Page 40 of 41
Issue history
Issue
Date
Ref
Details
By
1
31/05/2016
16D0601
First issue.
DG
6547/16D0601
Annex C
Page 41 of 41