11 MARKING

11.1 CE Marking

As a general rule New Approach directives including Directive 94/9/EC provide for the affixing of the CE marking as part of the conformity assessment procedures in the perspective of total harmonisation. The conformity assessment procedures to be applied are described in the relevant New Approach directives, based on the conformity assessment procedures as defined by Council Decision 93/465/EEC. Where a product is subject to several directives, which all provide for the affixing of CE marking, the marking indicates that the product is presumed to conform to the provisions of all these directives. During the transitional period of a New Approach directive the manufacturer has the choice to either meet the requirements of this directive or the previous relevant regulations. The option chosen, and hence the extent of the conformity expression enshrined in the CE marking, must be indicated by the manufacturer in the accompanying documents.

Any misleading marking in the sense of the any of these directives is forbidden.

As this guide has been especially drafted to facilitate the application of Directive 94/9/EC, the following explanations refer only to this Directive. If other directives are applicable in parallel, their provisions have to be taken into account in addition to those of Directive 94/9/EC.

CE marking is used by the manufacturer as a declaration that he considers that the product in question has been manufactured in conformity with all applicable provisions and requirements of Directive 94/9/EC and that the product has been the subject of the appropriate conformity assessment procedures.

The CE marking is mandatory and must be affixed before any equipment or protective system is placed on the market or put into service. As stated in Article 8 (3) components are excluded from this provision. Instead of being CE marked, components have to be delivered with a written attestation stating the conformity with the provisions of the Directive, stating their characteristics and indicating how they must be incorporated into equipment or protective systems. This separate statement goes along with the definition of components, which have as structural parts no autonomous function.

In general the CE marking must be affixed during the production control phase by the manufacturer or his authorised representative established within the European Union. In certain cases it is possible to affix the CE marking earlier, e.g. during the production phase of a complex product (e.g. a vehicle). It is then necessary that the manufacturer formally confirms the compliance of this product with the requirements of the Directive in the production control phase. The CE marking must consist of the initials "CE" taking the form described in Annex X to Directive 94/9/EC. In general the CE marking must be affixed to the product or to its data plate. However, although it is not a requirement in Directive 94/9/EC, it is considered reasonable to affix the CE marking to the packaging and to the accompanying documents if it is not possible to affix it to the product because of the product's size or nature.

It would be sensible, but it is not mandatory, to affix the CE marking to more than one place, for example, marking the outer packaging as well as the product inside, would mean that the marking can be ascertained without opening the package.

The CE marking shall be affixed distinctly, visibly, legibly and indelibly. It is prohibited to affix any marks or inscriptions that are likely to mislead third parties as to the meaning and form of the CE marking. The requirement for visibility means that the CE marking must be easily accessible for market surveillance authorities as well as visible for customers and users. For reasons of legibility a minimum height of 5 mm of the CE marking is required. This minimum dimension may be waived for small-scale products. The requirement for indelibility means that the marking must not be removed from the product without leaving traces noticeable under normal circumstances.

Depending on the conformity assessment procedure applied, a Notified Body may be involved in the design phase (Annex III), the production phase (Annexes IV, V, VI, VII, IX) or in both phases. The identification number of the Notified Body only has to accompany the CE marking if the Body is involved in the production control phase (see Article 10(1) of Directive 94/9/EC). It is necessary to avoid any misleading information on equipment, for example the number of the Notified Body, where this is not foreseen by the Directive. Hence, the product should not have the number of a Notified Body affixed, if falling under Category 3 (other than Unit verification), as well as some Category 2 equipment, and for any voluntary certification.

The CE marking and the identification number of the Notified Body do not necessarily have to be affixed within the territory of the EU. These can be affixed in a third country if the product, for example, is manufactured there and the Notified Body either performed tests on the product type or assessed the quality assurance system of the manufacturer in that country. The CE marking and the identification number can also be affixed separately, so long as the CE and body-number remain combined. In case of components only the identification number of the Notified Body has to be affixed.

Where equipment that has already been placed on the market is incorporated into a product (e.g. an assembly according to 3.7.5.1), the integrated equipment must bear the CE marking and, if appropriate, the identification number of the Notified Body.

Whilst it is recognised that sub assemblies may have CE marking affixed in their own right these might not be visible following construction of the final product. This is acceptable as this information can be found elsewhere. However, the final product must have a single label clearly relating to its final assembly prior to it being placed on the market and/or taken into service. In affixing the CE marking to the final product the manufacturer or his authorised representative accepts full responsibility for the conformity of the final product to the applicable Essential Health and Safety Requirements of Directive 94/9/EC and all other relevant directives.

11.2 Supplementary/Specific Marking

It is the intention of Directive 94/9/EC that the design of the specific marking of explosion protection  follows the design, as specified in Directive 84/47/EEC. Although there is no requirement in Directive 94/9/EC it is recommended to continue to use the established design (see Annex I to these Guidelines). This marking has to be followed by the symbol of the group and category (on devices according to Article 1(2) of Directive 94/9/EC the category should be indicated in brackets) and, relating to Group II, the letter ‘G’ (concerning explosive atmospheres caused by gases, vapours or mists) and/or D (concerning explosive atmospheres caused by dust). User instructions shall explain in detail the meaning of the marking on the product. However it is recommended to use the format provided in the following examples, where

" .. / .. " means the product has two different categories

".. - .. " means that a part of the product is not conforming to the Directive and not intended to be used in a potentially explosive atmosphere.

Moreover, devices according to Article 1.2 of the Directive, and separately placed on the market, shall be marked with the category of the equipment under control in round brackets, and such devices which contain an own potential ignition source intended for use in a potential explosive atmosphere shall be marked as equipment according to Annex II clause 1.0.5.

Examples for marking of equipment having different categories are:

All products must be marked with the name and address of the manufacturer, designation of series or type, serial number (if any) and the year of construction. The product must be accompanied with written information explaining the different categories and the consequences for the intended use.

Where a product is covered by more than one New Approach directive, CE marking denotes compliance with the appropriate provisions of all relevant directives. However, where one or more of these directives are in their transitional period and, as a consequence, allow the manufacturer to choose which arrangements to apply, the CE marking indicates conformity only to those directives where application is mandatory and others which are so applied. In the case of these latter directives particulars must be given in the documents, notices or instructions accompanying the product or, where appropriate, on the data plate.

11.3 Additional marking for standards

Because of the special importance for the safety of products intended for use in potentially explosive atmospheres and in order to avoid any misunderstandings Directive 94/9/EC provides for additional markings (see Annex II 1.0.5. Marking).

It is stated in Annex II 1.0.5 to the Directive that equipment, protective systems and components must furthermore be marked with all necessary information essential to the safe use. According to this requirement European standards for electrical and non-electrical products for potentially explosive atmospheres foresee a supplementary marking. For detailed and complete information about this marking it is necessary to use these standards.

11.4 Marking of components

The person responsible for the placing on the market and/or the putting into service of a product has to mark it with the name and the address of the manufacturer, according to Annex II to Directive 94/9/EC, clause 1.0.5. The Directive leaves it free to choose between trademark and company name if there is a difference. The address must be shown on the marking. This address can be simplified if there is not really enough room on small products, as long as the responsible person can always be identified. In any event, the address on the plaque must be sufficient for mail to reach the company. An internet address is not sufficient but the postal address has to be given. In some countries a unique postal code identifies an address. The use of this postal code is sufficient with the country.

The question has arisen, whether the marking of components is mandatory.

Strictly speaking, Directive 94/9/EC explicitly requires marking in Annex II, clause 1.0.5., only for equipment and protective systems. The question, whether components should nevertheless be marked in order to facilitate the implementation to the Directive, has particular practical relevance in cases

• where it is difficult to recognise the difference between ATEX components and standard components, and
• where a manufacturer who wanted to use a component might have serious problems undertaking his risk assessment, if there is no indication about the category of the component.

Apart from the question of marking, the Directive requires an attestation of conformity for components. The latter shall give all the necessary information stating the characteristics. This normally occurs assigning to the component an explosion classification according to relevant harmonised standards, which looks like a marking (e.g. Ex II 1/2 GD cb Tx or Ex II 1 GD c Tx).

For components having an own potential ignition source or which are clearly correlated (with respect to the properties of the component) to equipment with a given category, it has been considered that without the definition of group and category, the necessary conformity procedure of the equipment, which the component will be incorporated to, cannot be performed.

In some cases the conformity procedure can only be performed, if the equipment, which the component will be incorporated to, is defined, and if this incorporation is a matter of the conformity procedure.

Therefore, it is recommended to mark components, as long as these can be assessed with respect to a certain category and group of equipment, indicating this category and group in the marking.

Moreover, it is recommended to mark components for autonomous protective systems, which can be assessed with respect to the characteristic properties of the latter, as far as reasonable indicating these characteristics in the marking.

It has also to be considered that size is a problem impeding marking on a product. In these cases, the information should be given in the accompanying documentation and on the packaging of the component subject to marking.

Finally, it is recalled that, according to Directive 94/9/EC, ATEX components shall not bear the CE-marking.

11.5 Marking of small products

In accordance with the guidance given to the CE marking of products, it is also considered reasonable to affix all other marking to the packaging and the accompanying documents if it is not possible to affix it to the product because of the product's size or nature.

On very small products where a reduction in the marking is unavoidable, the following information is nevertheless required:

• CE marking (not for components),
• Ex marking,

the name or registered trade mark of the manufacturer.

11.6 Marking of assemblies

The marking of assemblies is identical to the marking of equipment, in particular equipment having different categories. An assembly may consist of a large number of assessed and compliant items (equipment, protective systems, safety devices) with their own specific marking, potentially of different categories. In such cases it would not be helpful to show all of these the individual markings in the marking of the complete assembly. Nevertheless, the marking of the assembly has to display all relevant information required by Annex II, 1.0.5, of Directive 94/9/EC necessary for the intended use of the assembly as a whole. The marking shall be placed in such a way – e.g. on the outer housing of the assembly – so that there is no doubt that it shows the characteristics of the whole assembly and not just one part.

Assemblies may consist of parts of different categories and be intended for potentially explosive atmospheres having different physical characteristics. The marking of the assembly as a whole with group, categories and additional information essential for the safe use of the assembly (temperature class, etc.) may fall under one of the two following scenarios:

Case 1: The assembly as a whole is intended for use in one potentially explosive atmosphere of one specific zone

Where the individual parts of the assembly are marked for potentially explosive atmospheres having different characteristics, the part with the lowest level of safety defines the marking of the whole assembly. That means that the category, temperature class, explosion group etc with the lowest requirement for the equipment has to be used for the marking of the whole assembly.

Case 2: Parts of the assembly are intended for use in potentially explosive atmospheres having different physical characteristics and/or different zones

If it is essential for that intended use, the marking of the assembly shall contain all groups, categories and additional markings (temperature class, etc.) necessary for the intended atmospheres. In this case, the instructions for use, installation etc. will indicate the different atmospheres/zones intended (and/or provided by constructional measures) in or around different parts of the equipment.

Examples (only categories and additional markings essential for safe use are given in these examples):

Examples for case 1:

• An assembly consisting of parts marked with T3 and other parts with T6 shall be marked T3 to indicate, that it is, as a whole, intended for use in T3 atmospheres.
• A pump unit consisting of a liquid pump (non flammable liquid) and driving electric motor. The pump is marked II 2 G T6, the motor II 2 G IIB T4. The whole assembly shall be marked II 2 G IIB T4, as the motor is the part that meets the lower requirements.
• • A similar pump unit with a pump conveying hot liquid (non flammable). The pump is marked II 2 G T3, the motor II 2G IIB T4. In this case the assembly shall be marked II 2 G IIB T3. Examples for case 2:
• A fan conveying a IIA T3 explosive atmosphere (Zone 1), the fan fitted with an electric motor and some control devices placed in a Zone 2, the fan accordingly marked II 2/3 G IIA T3. The motor is marked II 3 G T3, the intrinsic safe control device II 2 G IIC T6. As the intrinsic safe control device is placed in the same atmosphere as the motor, the part meeting the lower requirements (in this case the motor) is the decisive item. Accordingly the marking of the whole assembly is II 2/3 G IIA T3.
• A similar fan assembly, but with the motor placed outside the hazardous area. The marking of the whole assembly is II 2/3/- G IIA T3.

10 DOCUMENTS OF CONFORMITY

10.1 Documents issued by the manufacturer

10.1.1 EC Declaration of Conformity⁵¹

Once the manufacturer has undertaken the appropriate procedures to assure conformity with essential requirements of the Directive it is the responsibility of the manufacturer or his authorised representative established in the EU to affix the CE marking and to draw up a written EC Declaration of Conformity.

The manufacturer or his authorised representative established within the EU keeps a copy of this EC Declaration of Conformity for a period of ten years after the last equipment has been manufactured.

Where neither the manufacturer nor his authorised representative is established within the EU, the obligation to keep the copy of the EC Declaration of Conformity available is the responsibility of the person who places the product on the EU market.

In respect of the Notified Bodies possibly involved in the conformity assessment procedure the EC Declaration of Conformity must contain, where appropriate, the name, identification number and address of the Notified Body and the number of the EC-Type Examination Certificate. The name and address of a Notified Body involved in the production phase, where relevant, is not a mandatory requirement.

As far as assemblies of ATEX equipment are concerned, if an assembly is to be treated as a new item of ATEX equipment the EC Declaration of Conformity needs only to identify the unit and the related information. Details of the items of equipment making up the assembly will be included on the technical file. However, there is a duty on all those in the supply chain to pass on the relevant information relating to the items of equipment where these have been previously placed on the market accompanied by their own EC Declaration of Conformity and instructions.

Annex X.B of the Directive states what the EC Declaration of Conformity must contain. Further information can be found in section 5.4 of the "Blue Guide". As a general rule, the content of the EC Declaration of Conformity contains the following:

10.1.2 Written Attestation of Conformity for components

The EC Declaration of Conformity should not be confused with the written Attestation of Conformity for components mentioned in Article 8(3) of Directive 94/9/EC. In addition to declaring the conformity of the components with the provisions of the Directive, the written attestation of conformity has to state the characteristics of the components and how the components are to be incorporated into equipment or protective systems to ensure that the finished equipment or protective system meets the applicable Essential Health and Safety Requirements of Directive 94/9/EC.

10.1.3 Documents accompanying the product

According to Articles 4(2) and 5(1) of Directive 94/9/EC and for the purposes of market surveillance the EC Declaration of Conformity / the written Attestation of Conformity must accompany the information given with each single product, or each batch of identical products delivered for the same end user.

The product is also accompanied by instructions for safe use (see EHSR 1.0.6 of Annex II to the ATEX Directive 94/9/EC). The manufacturer shall provide to the user written instructions that include the necessary information for repair, maintenance and/or overhaul of the equipment concerned. The manufacturer does not have to provide the full technical file.

EHSR 1.0.6 does not specify the form of the instructions. It is generally agreed that all health and safety related instructions must be supplied in paper form, since it cannot be assumed that the user has access to the means of reading instructions supplied in electronic form or made available on an Internet site. However, it is often useful for the instructions to be made available in electronic form and on the Internet as well as in paper form, since this enables the user to download the electronic file if he so wishes and to recover the instructions if the paper copy has been lost. This practice also facilitates the updating of the instructions when this is necessary.

The user takes into account the instructions issued by the manufacturer to carry out repair, maintenance and/or overhaul on the basis of the requirements of the applicable directives (as 2009/104/EC - Use of work equipment by workers at work and 1999/92/EC - Protection of workers potentially at risk from explosive atmospheres) and of relevant specific national legislation that regulates the repair, maintenance and overhaul of used equipment. The instructions must contain drawings and diagrams necessary for repair of the equipment. Applicable and technically accepted standards can also be used, for example EN 60079-19 - Explosive atmospheres - Equipment repair, overhaul and reclamation.

However, where necessary, the manufacturer can include in his documentation a statement that specific repair, maintenance and/or overhaul of the equipment shall only be conducted by the manufacturer himself, or by a repairer he has qualified or authorized.

With respect to assemblies, it is important to the safe installation, operation and maintenance of the assembled unit that all relevant information is passed to the end user. The manufacturer of the assembled unit should do this by including all related information in a package supplied to the end user.

10.1.4 Retention of documentation - Quality assurance

According to Annex IV, paragraph 5 of the ATEX Directive 94/9/EC the manufacturer, or where relevant, the authorised representative or importer) shall, for a period ending at least 10 years after the last piece of equipment was manufactured, be able to make available to the national authorities:

• the documentation of the quality system;
• updating of the quality system;
• • audit reports and certificates of the Notified Body. Larger organisations have a certified quality management system according to the ISO 9000 standards. For these manufacturers it is recognised that it is difficult to keep all quality documents and all changes to the quality system for such a long period. It is the opinion of the ATEX Standing Committee that the requirements in Annex IV, paragraph 5 of the ATEX Directive 94/9/EC are fulfilled if the manufacturer keeps at the disposal of the national authorities at least the actual quality management system documents + the following documents which have to be kept for a period ending at least 10 years after the last piece of equipment was manufactured:
• audit reports and certificates of the ISO 9000 certifier. This will be one or two audit reports per year that include the actual state at that moment of the quality system with changes;
• audit reports and notifications of the Notified Body that issued the Production Quality Assurance Notification.

The above consideration is against the background that this documentation shall always be sufficient so as to enable surveillance authorities to determine that the relevant conformity assessment procedure(s) was/were applied in a satisfactory manner and that the relevant obligations of the ATEX Directive 94/9/EC were fulfilled.

10.1.5 Acceptance of test results of manufacturers by a Notified Body

Test reports can be a part of the technical documentation the manufacturer has to present to the Notified Body and the latter may take them into consideration appropriately.

Concerning safety relevant aspects in connection with Annex III (EC-Type examination) and Annexes V (Product verification) and IX (Unit verification) to Directive 94/9/EC, a Notified Body's independent and transparent intervention vis-à-vis the client and all interested parties (e.g. Member States, European Commission, manufacturers, Notified Bodies) is required legally. Therefore a Notified Body only may accept test reports of manufacturers under certain conditions. The requirements included in the standard EN ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025) shall be used as basis for acceptance of test results.

The Notified Body has to state the acceptance of test results in his test report.

In any case the Notified Body remains fully responsible for accepted test results and for the EC-Type Examination Certificate (Annex III) or Certificate of Conformity (Annexes V and IX) based on them.

10.2 Documents issued by the Notified Body

The Notified Body issues the following documents according to the provisions of the relevant conformity assessment procedures:

• EC-Type Examination Certificate;
• product and production quality assurance notification;
• conformity to type notification;
• product verification, certificate of conformity;
• unit verification, certificate of conformity.

These documents need not accompany the product.

It is not possible to issue an EC-Type Examination Certificate for products of Category 2 nonelectrical equipment and of Category 3, as mentioned in Article 8(1)(b)(ii) and 8(1)(c). Further, it is also not permissible to list such goods on an EC-Type Examination Certificate issued for goods of categories other than these. This is because an EC-Type Examination Certificate is an attestation that the goods listed on it have undergone the necessary conformity assessment procedures that result in the issuing of an EC-Type Examination Certificate; it is not necessary for such goods to undergo such conformity assessment procedures.

Where a single item is covered by more than one category, it may be permissible to issue an EC-Type Examination Certificate. Under such circumstances, these items need to comply with the highest applicable conformity assessment requirements (see section 8.1). If this requirement results in an EC-Type Examination Certificate being issued, these goods are permitted to be listed on an EC-Type Examination Certificate.

A typical example of this is found in the semiconductor fabrication industry where a high vacuum pump is used to extract hydrogen but cannot meet the physical clearances necessary to justify Category 2. Category 3 is adequate for the process as the pump is normally filled with pure hydrogen at low pressure, so there is no ignition risk except during the very brief transitions between operation and non-operation.

In this case, it is only the electrical part that is truly subject to EC-Type examination but it is already established that a mechanical part can be considered along with the electrical part if they are integral with each other, rather than a mere assembly.

In such cases, it is not unreasonable to mention such items in the same set of documentation i.e. the goods have an EC-Type Examination Certificate issued for them.

However, where the goods are discrete items e.g. two different type categories of a hand-held radio, one of which is Category 2 and the other Category 3, a single EC-Type Examination Certificate should never be issued; the Category 3 goods should be listed on a separate document that in no way implied it was an EC-Type Examination Certificate. The same should be true for components of items.

However, the voluntary issue of a certificate for goods that are not permitted to be listed on an EC-Type Examination Certificate is possible. The certification body may not give an indication on the certificate that it is a Notified Body because it would not be acting in that capacity. Therefore, the number of the Notified Body must not be affixed. Further, it is not permissible to affix the CE marking to such certificates. There is no objection for the hexagon (Ex mark) to be used or to make reference to Directive 94/9/EC.

Provision of evaluation and test results with EC-Type Examination Certificates: although being a separate document, the report describing how the equipment fulfils the Essential Health and Safety Requirements of the Directive is considered to be integral to the provision of a certificate. Evaluation and test results supporting the decision to issue an EC-Type Examination Certificate should accompany the certificate from the Notified Body to the manufacturer.

10.2.1 Minimum content of a European standardised ATEX Test and Assessment Report

The term "test report" is used in a twofold way. In fact certification in scope of 94/9/EC is based on three levels of reports:

• test in a laboratory, for example the measurement of a temperature, following called test report;
• assessment to the requirements of harmonised standards, following called assessment report;
• assessment to the Essential Health and Safety Requirements of the Directive, following called assessment report, too.

Having very different types of test reports issued, varying from very poor reports, hardly including any information, to test reports with detailed test and evaluation results, a standardised ATEX Assessment Report format enables and ensures the following goals:

1.  Recognizable as an ATEX Assessment Report.
2.  Specified minimum content.
3.  Meeting the requirements for test reports as laid down in EN ISO/IEC 17025 and other applicable standards.
4. Easy to use/integrate with existing formats currently used by all ATEX Notified Bodies.
5. An ATEX Assessment Report is only issued if all applicable requirements are met and if all tests have been conducted with positive results (but still allowing waiving tests provided that the reasoning is given in the test report).

Recognizable as ATEX Assessment Report

The ATEX Assessment Report should be easy to identify as such by manufacturers, Ex Notified/Certification Bodies and any other party as a genuine ATEX Assessment Report. To realise this, an identical approach could be followed as for the content and format of ATEX Annex III EC-Type Examination Certificates; laid down in ExNB Clarification Sheet No. ExNB/09/340. Another possibility is to just require the use of the wording "ATEX Assessment Report" (exact wording to be agreed upon) on the cover page of the report; without the need for a standardized template for the ATEX Assessment Report as has been done for Annex III Certificates.

Specified minimum content

The report shall contain a minimum amount of information that enables manufacturers to easily obtain other local/regional approvals/certificates based on the information in the report and any associated test documentation. An assessment report issued by an ATEX Notified Body that supports the issue of an EC Type Examination shall contain:

• General information about the product, type designation, applicant, manufacturer, types of protection, technical data.
• Technical evaluation of the construction of the equipment. For most types of protection this can be a checklist (Yes/No/Not applicable + remarks) combined with the test documentation

that specifies the construction; for intrinsic safety however a descriptive format is usually the best (if not the only) useable format. A detailed assessment narrative that confirms compliance with the standards used to support compliance with the ATEX Directive. If no standards are used, then the assessment narrative shall confirm compliance with the Directive. Since explosion safety standards are concept standards occasionally some interpretation is involved: the report should make clear how the assessment has been carried out.

• Results of tests

• o details of tests carried out, relevant information about the test conditions, method and results shall be provided as part of the test report;
• o details of tests that have been waived and the justification for waiving those tests (the standard EN 60079-0 calls for a justification for waiving tests) shall be part of the assessment report;
• o details of tests that have been accepted from other organisations, test laboratories, etc. and a justification for accepting those tests shall be part of the assessment report. If tests are being accepted from other sources, then this should be clear, because the body that produces that data should be scrutinised. It could easily be disguised that test data from unsuitable sources had been used.

• Routine tests, if any: applicable to the product and agreed upon between the manufacturer and the Notified Body (applicable standards are EN 13980 or IEC 80079-34, too).

Requirements for reporting

An ATEX Test Report shall meet all requirements for the content of test reports as

• specified in EN ISO/IEC 17025. In practice, this should not be any problem for a Notified Body since all conduct and report testing according to EN ISO/IEC 17025;
• an ATEX Assessment Report shall meet all requirements as specified in EN 45011.

Easy to use and integrate by Notified Bodies

It should be easy to integrate the European standardized ATEX Assessment Report in the operational procedures and documents used by a Notified Body. This requires that the format itself should not be 100% specified in detail, but only to the extent that all parties involved – issuing and receiving Notified Bodies and manufacturers – know what to find in the test report. So the focus is on the content of the report, not its layout, numbering, etc. This should make it easy to implement the ATEX Assessment Report in the existing way of working of all individual Notified Bodies. It should not cause a significant increase (if any) in the costs for the manufacturer to obtain an ATEX Certificate.

Full report

To avoid any confusion about the expected content of an ATEX Assessment Report, such report should only be issued when the product involved meets all applicable requirements and has passed all applicable tests with positive results. An ATEX Assessment Report shall not be issued in case of any negative results or in case that only a part of the applicable requirements (for example IP54 requirements) have been evaluated or tested. This does not preclude the issuance of an ATEX Assessment Report for an Ex component, certified under a "U" certificate.

If a report with negative results or not fully assessed applicable requirements is given to the manufacturer is must be unambiguous that this is not an ATEX Assessment Report.

10.3 EC-Type Examination Certificate and the responsibilities of stakeholders

A Type Examination Certificate attests that a specimen (including instructions, as appropriate) representative of the production envisaged by the manufacturer fulfils the relevant applicable provisions of the Directive, in particular the Essential Health and Safety Requirements (EHSRs).

The question arises as to the actions that need to be taken when the "generally acknowledged state of the art" has developed. It is clear that the original specifications applied may continue to show fulfilment of the EHSRs and the Type Examination Certificate then remains valid.

However, over time the "generally acknowledged state of the art" can develop substantively such that the specifications originally applied no longer ensure the type examined complies with the EHSRs. It should be noted that the question of whether there has been substantive development of the state of the art is not left to discretionary interpretation by the Notified Body, but has equally to be generally acknowledged by the technical community of the stakeholders. The publication of a revised harmonised standard would be one way to recognise a development in the state of the art: in this case, the responsible European Standardisation Organisation (ESO) shall determine whether the state of the art concerning the EHSRs has changed, and if so, in what respects. The ESO shall indicate this in the foreword of each standard.

In such cases, if the specifications and evaluation criteria originally applied to a product no longer ensure that it complies with the latest state of the art, the Type Examination Certificate is no longer valid and further action is required. Given reasonable transition periods and knowledge of current developments, it is expected that the manufacturer will have sufficient time to contact a Notified Body to undertake the necessary re-evaluation so that there is a smooth transition from one set of applied specifications to another. Notified Bodies, who are expected to maintain a good knowledge of developments in the state of the art, should make arrangements to alert the holders of their EC-Type Examination Certificates to the revision of harmonised standards.

It should be noted, however, that the issuing of a new Type Examination Certificate will have no retroactive effect and, therefore, will not affect products placed on the market and/or put into service whilst the manufacturer was in possession, where appropriate, of a valid Certificate.

It should also be re-affirmed that the overall responsibility for compliance of the product rests with the manufacturer who, where required, must ensure that a valid Certificate is in his possession, as well as that all relevant conformity documents correspond to the current state of the art. In parallel, the Notified Body must provide all the relevant information for the manufacturer in order to ensure that the existing Certificate is correct in its evaluation that the type continues to meet the EHSRs.

Equipment of Groups I & II Categories M 1 and 1 * and Autonomous Protective Systems

 

 

(*) and their components and devices according to Art. 1(2), if separately assessed

Note: According to Article 8.4 for all equipment and protective systems of all groups and categories conformity to 1.2.7 of Annex II of the Directive (protection against other hazards) can be fulfilled by following the procedure of internal control of production (Annex VIII).

Which conformity assessment procedures have to be performed in the case of different categories within one product, or mixes of equipment and protective systems according to Article 1.3 b ?

If a product is made of parts which are assigned to different conformity assessment procedures it will be up to the manufacturer to decide how these parts and the whole product shall be placed on the market. The manufacturer can decide to realise the appropriate conformity assessment procedures for each part or for the whole product, even if he decides to place the product as an entity on the market. In the case of separate conformity assessment procedures for each part of the assembled equipment (called assembly in the Guidelines to Directive 94/9/EC), the manufacturer may presume conformity of these pieces of equipment and may restrict his own risk assessment of the assembly to those additional ignition and other hazards, which become relevant because of the final combination. If additional hazards are identified a further conformity assessment of the assembly regarding these additional risks is necessary.

If the manufacturer explicitly asks a Notified Body to assess the entire product, then that conformity assessment procedure has to be applied, which covers the highest requirements. The Notified Body shall include into the EC-Type examination (if relevant) all aspects of the product. Existing conformity declarations of the manufacturer for parts of the product should be given due consideration.

The Notified Body should inform the manufacturer about the possibilities of separate conformity assessment procedures for each part of the assembly as pointed out by the Guidelines to Directive 94/9/EC.

Any certificate issued by the Notified Body should make clear which aspects of the product have been assessed by the NB, and which have been assessed by the manufacturer alone.

Example: Vapour recovery pump for petrol stations

(a) The pump is sucking the petrol vapour-air mixture from the atmosphere and conveying it in pipe­work attributed to Zone 0. Accordingly it is connected at its inlet and outlet to a potentially explosive atmosphere classified as Zone 0. The pump itself is placed in a Zone 1 environment.

With regard to the inlet and outlet connection the pump then has to comply with the requirements for Category 1 equipment. The corresponding EC-Type examination (equipment) has to be carried out by a Notified Body. With regard to the remaining (outer) body and integrated parts of the pump the Notified Body includes the necessary Category 2 assessment into the certification, even if there are only non-electrical ignition sources to be considered.

Both categories shall be indicated in the EC-Type Examination Certificate, making clear which aspects of the product have been assessed by the Notified Body, and which have been assessed by the manufacturer alone, and in the marking. For those Category 2 parts of the pump, which show only non-electrical ignition sources and which are placed separately on the market, and for which the technical documentation has been communicated to a Notified Body, an EC declaration of conformity (for equipment) or a written attestation of conformity (for components) of the manufacturer are sufficient.

(b) Often the pump is expected to prevent the passage of a deflagration flame from the inlet to the outlet connection, as typical vapour recovery pumps contain flame arresters in the inlet and outlet pipe. In this case the pump simultaneously may qualify as a protective system (in-line deflagration arrester).

A Notified Body – after having carried out a corresponding assessment of the flame arresting capability – may then issue a separate EC-Type Examination Certificate for the pump as a protective system. In case that both aspects (equipment and protective system) have been assessed by the same Notified Body, only one EC-Type Examination Certificate may be issued.

8.2 Exceptional derogations of the Conformity Assessment Procedures

All equipment and protective systems referred to in Article 1 (1) including components and the devices referred to in Article 1 (2) are covered by the provisions of Article 8 (5).

This article gives the competent authority of the relevant Member State the possibility, in exceptional circumstances, to authorise the placing on the market and putting into service products where the Conformity Assessment Procedures have not been applied. This exception is possible:

• following a duly justified and successful request to the competent authority of the relevant Member State; and,
• if the use of the product is in the interests of protection of health and safety, and where, for example, such interests would be hindered by the delay associated with Conformity Assessment Procedures; and,
• is restricted to the territory of the Member State concerned.

This provision may be applied in safety relevant cases, in which the products in question are needed urgently and there is insufficient time to undergo the complete Conformity Assessment Procedures (or to complete these procedures). The intention is to give Member States (in the interest of health and safety) the possibility to allow the placing on the market and putting into service innovative products without delay. Even in such cases the essential requirements of the Directive must be fulfilled.

With regard to the restrictive application conditions it has to be emphasised that the use of this clause has to remain exceptional and must not become a normal procedure. In the interests of transparency and to assist administrative co-operation Member States are encouraged to provide the competent Commission services with details of any use of Article 8(5).

Corrigendum to Commission communication in the framework of the implementation of Directive 2006/42/EC of the European Parliament and of the Council on machinery, and amending Directive 95/16/EC

( Official Journal of the European Union C 54 of 13 February 2015 )

(2015/C 087/03)

On page 14:

for:

read:

On page 54:

for:

read:

http://eur-lex.europa.eu/legal-content/FR/TXT/?uri=OJ:C:2015:054:TOC 

http://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:52015XC0213(03)R(01)&from=EN

Transposition of the ATEX 94/9/EC Directive to the 2014/34/EU Directive 

We often have many questions such as the following:

• From what date a manufacturer must refer to the new ATEX Directive 2014/34/EU in its EU declaration of conformity ?
• Should the EC declaration of conformity has to match the new EU reporting format?
• Should manufacturer have to refer to the two directives specifying the date of repeal of the 94/9/EC and the date of application of the 2014/34/EU?
• Can manufacturer implement these new documents now?
• ...

The list could be continued again.
Because of all these kind of questions the European Commission has published on 10.15.2015, publication in English language only has the time or of writing.

• GUIDANCE DOCUMENT ON THE ATEX DIRECTIVE TRANSITION FROM 94/9/EC TO 2014/34/EU au format PDF

Commission communication in the framework of the implementation of Directive 94/25/EC of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to recreational craft

(Publication of titles and references of harmonised standards under Union harmonisation legislation)

(Text with EEA relevance)

(2016/C 014/03)

http://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:52016XC0115(03)&from=DE

Two Channel Structure

Description of the Technique

Two channel structures, in the sense as used in this handbook, comprise two independent funtional units for the carrying out of the specified function o The two funtional units can be identical or they can be built up in different ways using the principle of diversification (hardware diversification, software diversification, and time diversification). The signaIs which are used by or produced by both systems are continuously compared with one another for the purposes of fault detection. This comparison can be carried out somewhat crudely (e. g. comparison of relevant input and output signaIs) or it can be very detailed (comparison of states of the system, bus signaIs, etc.). The comparison itself can be made in a variety of ways:

a) by fail safe comparator (external)

b) by external tested comparator

c) by internaI mutual comparison.

Characteristics and Special Features of the Technique

This technique will detect aIl faults which make themselves evident on the inputs of the comparator, even when they are caused by disturbances.

As far as in the comparison of e. g. digitalised analog signaIs and the like, certain tolerances are permitted or have to be considered, suitable "windows" must be provided for this purpose in relation to time and to measured values.

complementary tests should be arranged for those faults which do not make themselves apparent sufficiently quickly via the comparison system.

Special Factors in the Application and Incorporation of the Technique

In diversified two channel systems, it is only possible to compare the output results. Comparison of states of the system calls for identical construction and a completely synchronous running of the two channels; this is as a rule only feasible if both channels have a common time base. A second, independent time base must therefore be provided as an added feature in such systems.

As with aIl test programs, the periodical and complete carrying out of the complementary tests must be monitored.

Checking

The checking is carried out via an analysis of the switching circuitry involved (in some cases, where necessary, including proof tests of the hardware diversification), by checks as to the contents of the programs for the complementary tests and by fault simulation, especially at the comparator unit, where necessary at the second time base, as weIl as for those faults which are not revealed by the comparison.

Literature for Further Reading

Further details and examples of systems which have been realized will be found among others at /DEK/, /DER/ and /WIE/.

elsewhere.

Commission communication in the framework of the implementation of Directive 94/9/EC of the European Parliament and of the Council of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres

(Publication of titles and references of harmonised standards under Union harmonisation legislation)

(Text with EEA relevance)

(2015/C 335/02)

The official terms and definitions for all the terms used in standards are available from :

the ISO website : 

for example for functional safety : https://www.iso.org/obp/ui/#iso:std:iso:25119:-1:ed-1:v1:en:term:3.20 

the IEC website : http://www.electropedia.org/

ANNEX II: BORDERLINE LIST - ATEX PRODUCTS

BORDERLINE LIST - ATEX PRODUCTS

The List has been confirmed during the Directive 94/9/EC ATEX Working Group meeting on 12 July 2012

Note that the list is not complete, it only clarifies some common inquires and provide examples of products within or outside the scope of the ATEX Directive 94/9/EC. The List does not replace the vital risk assessment of each product and in addition ignition sources and explosion hazards related to the use of all the products shall also always be considered.

Note 1: Additional information can be obtained in the ATEX Guidelines and Standing Committee Considerations to Directive 94/9/EC but also in the Non-binding Guide to Directive 1999/92/EC.

Note 2: Equipment, protective systems, Ex components, safety, controlling, regulating devices and/or other products indicated as not falling within the scope of ATEX 94/9/EC, ignition sources and explosion hazards related to the use shall be considered. Friction impacts and abrasion processes involving rust and light metals (e.g. aluminium and magnesium) and their alloys may initiate an aluminothermic (thermite) reaction, which can give rise to particularly incendive sparking.

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