EX-cellent CE marking
10 June 2010
EX product certification for Europe is governed by the ATEX equipment directive 94/9/EC under the European Commission’s new-approach (CE marking) regime and is one of several directives or requirements relevant to equipment for potentially explosive atmospheres. Read More
Manufacturers may also have to consider the design, documentation, manufacturing and quality system implications for EMC, machinery safety, electrical safety and radio/telecoms compliance before applying the CE mark.
2010 brings in new CE requirements, set out in Council Decision 768/2008. The Decision also sets out restriction, prohibition and recall provisions for persistent non-compliance in equipment safety or supporting documentation. The Decision is likely to be applied, within twelve months, to all current directives.
In addition to regulatory aspects, functional (e.g. radio/telecoms) and/or environmental performance criteria (e.g. vibration, shock, wind, rain) may apply. TRaC provides notified body, certification body and testing laboratory services for these complementary directives, from its seven UK sites.
The CE mark
The original CE marking Decision was repealed on 1 January 2010 and replaced by Council Decision 768/2008 – a general framework for future CE marking legislation, the marking processes, conformity assessment procedures and enforcement provisions.
The CE mark is a free trade mark, not a purchasing mark: there is no obligation placed upon the manufacturer to provide much of the supporting documentation. In practice, it is used for purchasing purposes as users try to satisfy their own legal obligations.
A CE mark, which is identical for all directives, means that an equipment manufacturer has applied all of the requirements of all of the applicable directives. The mark can be suffixed with the 4-digit number of a notified body, if one is involved in the conformity assessment procedure.
The Declaration of Conformity
The Declaration of Conformity is probably the most critical part of the CE mark system, as per Council Decision 768/2008, that details all of the directives applied to each product and the supporting standards. Each directive specifies its own content requirements; however in detail, they are not identical. The Decision also sets out the model layout and text to be followed for an EC Declaration of Conformity, based on ISO/IEC17050. This is a change to previous practice but reinforces the key elements needed to demonstrate compliance.
Specific directives require other, legislation-specific, declaring documents, for example the Declaration of Incorporation (DoI) used for incomplete assemblies under the Machinery Directive, and the Certificate of Attestation (AoC) used for components under the ATEX directive.
Content of Declaration of Conformity
1. No … (unique identification of the document):
2. Name and address of the manufacturer or his authorised representative:
3. This declaration of conformity is issued under the sole responsibility of the manufacturer (or installer):
4. Object of the declaration (identification of product allowing traceability. It may include a photograph, where appropriate):
5. The object of the declaration described above is in conformity with the relevant Community harmonisation legislation: (list all directives with dates).
6. References to the relevant harmonised standards used or references to the specifications in relation to which conformity is declared: (list all standards with dates and list non-harmonised standards separately).
7. Where applicable, the notified body ... (name, number) … performed … (description of intervention) … and issued the certificate:
8. Additional information: (e.g. use limitations).
The Declaration of Conformity – an administrative re-statement of facts – provides a good indication as to whether the CE marking process has been completed properly. Conversely, an incorrect Declaration questions the under-standing and application of the technical aspects. Therefore, its contents deserve careful attention, particularly where multiple directives are applied. TRaC have produced a paper on this subject - email firstname.lastname@example.org.
Best practice guide: Take great care with your Declaration of Conformity (or similar). Review/update all Declarations using the new ISO/IEC17050 model.
Several commonly used industrial directives (see list below) have recently been updated. Some are mutually exclusive (e.g. machinery safety/low voltage directive), but most apply in parallel. Where there is exclusivity, the predominant directive encompasses the essential requirements of both.
For example, the Low Voltage Directive (LVD) is the subject of an exclusion clause within both the Machinery and ATEX directives. However, within both, the technical requirements of the LVD are referenced with their own essential requirements and the effect of non-application is largely administrative. In the case of the ATEX directive, conformity assessment procedures do not extend to the LVD element; instead, compliance for this requirement is by manufacturer’s declaration. The details of the LVD standard are included on the Declaration of Conformity and the supporting evidence for compliance retained in the manufacturer’s technical file (under their sole responsibility). No further assessment is required by the ATEX directive.
It is the manufacturer’s responsibility to determine which directives apply, according to technology and end-use location of the equipment.
Best practice guide: Review all of the directives that you apply. Ensure any changes introduced by directive revisions have been applied to your equipment, documentation and systems.
List of key directives:
ATEX directive 94/9/EC
EMC directive 2004/108/EC
Low Voltage Directive 2006/95/EC
Machinery Safety Directive 2006/42/EC
Noise Directive 2000/14/EC
Radio & Telecommunications Terminal Equipment 1999/5/EC
Conformity Assessment Procedures
The new approach directives provide for eight assessment procedures or "modules" (A-H) covering design and production control (see box below). Each directive applies one or more of these modules to demonstrate conformity. Third party, notified bodies may supervise and verify the correct application of the modules. However, there is a general new-approach principle that conformity assessment procedures must be appropriate to the degree of risks. TRaC is a notified body for directives including the ATEX, EMC, Low Voltage, Machinery, Radio & Telecoms and Noise directives.
Only module A (internal production control) does not involve a notified body. However it is the most commonly applied module and the basis for many directives including Low Voltage, EMC and Machinery Safety. Module A appears as Annex VIII of the ATEX directive for category 3 (lowest risk) equipment. For higher risks, one or more of the other modules/Annexes apply.
The general principles of product conformity span all modules although the degree of third party supervision varies. For modules that permit self-attestation by the manufacturer, best-practice guidelines can be adopted from the appropriate third party supervised module.
Take the production control requirement of Annex VIII; the requirement is very open. By applying the requirements from Annexes IV – VII (without a third party) best practice production control can be achieved utilising standard EN13980. This approach complies with the UNECE-endorsed IECEx system which requires the same production control approach (using a technically equivalent standard OD005, available from the IECEx website, www.iecex.com) regardless of “category” or equipment risk.
Technical documentation is now required by the conformity assessment procedures of most of the key directives and there has been some degree of content harmonisation. Creation and maintenance of these files is mandatory and has renewed importance for enforcement agencies.
Normally the details of the applicable modules are outlined in the conformity assessment annexes (e.g. ATEX directive Annexes specify six of the eight modules). Multi-directive notified bodies can provide advice on appropriate options at an early stage.
Best practice guide: Whichever modules are applied, review the requirements, adopt the most coherent methods for your own use even if overseen by third parties. Ensure that technical documentation is complete and conforms to of all of the directives.
Essential (health and safety) requirements (E(HS)R)
The essential requirements (or essential health and safety requirements) create legally binding obligations; conformity can be assessed even in the absence of harmonised standards, or where the manufacturer chooses not to apply a harmonised standard. The detail wording depends on the characteristics of the industry sector and risk. This principle is re-iterated in the new Council Decision.
The E(HS)Rs permit conformity assessment without standard, a route historically used for machinery safety where few standards were available. For most other directives harmonised EN standards are widely available. Recent versions of all ENs relevant to directives now carry annexes that detail which E(HS)Rs they address. The ATEX directive has been well supported by EN standards. The E(HS)Rs in ATEX Annex II of the ATEX directive can readily be related to reference standards for component parts and assemblies.
Best practice guide: Apply harmonised standards wherever possible: recognise that the directives’ requirements are based upon the E(HS)Rs and not the standards. Manufacturers need to take a broad view of both sets of requirements to prove full compliance.
Control of production and factory audits
All of the directives require production control for series manufactured equipment. In module A this usually means product or quality assurance to ensure 100% type-conformance. Best practice requires the use of recognised product quality systems, even for module A. For other modules, including some ATEX annexes, some form of third party (notified body) involvement and/or use of ISO9001 may be required.
With or without a formal quality assurance system the principles of ISO9001 represent a best practice approach. EN13980 applies to all types of ATEX equipment, regardless of category or risk. If other (less prescriptive) directives are applied (even if only under module A) then the guidelines for a good ATEX system will apply equally. EN13980 and IECEx OD005 emphasise regular and rigorous internal audits of equipment and documentation. Internal audit applies to production control within all directives.
Best practice guide: Ensure production control follows the basic principles of ISO9001 (and supporting standards such as EN13980 when applicable). Ensure that internal auditing systematically reviews processes.
Standards CE marking legislation and directives avoid technical detail but focus on expression of essential requirements (E(HS)Rs). The new Decision sets out that these E(HS)Rs, where appropriate, have recourse to harmonised standards (listed on the Europa website) which in turn provide a presumption of conformity. The ATEX directive is supported by electrical and mechanical standards (EN60079 and EN13463 series). Electrical standards are largely based on international IEC standards: mechanical standards are currently based on CEN standards but in the future could relate to ISO standards.
Standards evolve; ATEX currently has many of its concept standards in revision or recently issued; there have been frequent changes in recent years, and multiple editions of standards are current. Global harmonisation means that new requirements can suddenly apply to local markets as well as overseas. A paper reviewing recent changes to ATEX standards is available from email@example.com.
Best practice guide: Use quality systems and internal audit processes to ensure that you have annually reviewed the all of standards that you use. If possible, build in a process for implementing revisions into the design. Consult with notified bodies regarding changes to standards.
CE marking can be complex and is subject to changes in both directives and supporting standards. To maintain product compliance, an ongoing plan must accurately identify all of the directives that apply to a product, for design, documentation and production control, and monitor the impact of changes.
For export outside the EU, while basic principles of product conformity are similar everywhere, the regulatory regimes for third party testing and auditing in some markets (e.g. USA) are more arduous than for the CE mark. Manufacturers who already have a rigorous CE system should encounter few problems applying either directly for overseas certifications, or using the IECEx or IECEE schemes - further information on both is available from TRaC.
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