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 CE NEWS
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THE NEW EMC DIRECTIVE: New test requirements if you want to keep selling your equipment in Europe

EMC Directive 2004/108/EC Repealed directive 89/336/EC on 20 July 2007. An overlap period of 2 years is now allowed for the new requirements to be implemented. Note that some requirements must necessarily be implemented immediately – see below regarding DoC and Notified bodies. The New Standards being published to replace the Standards previously referenced by manufacturers will have a significant impact, with mandatory new tests that are more severe than the previous tests.

Almost all existing and new products will require testing/re-testing or further assessment. Some products will need remedial/redesign work to comply at  the new levels if they are to be sold in Europe after 01 June 2008.

Applicability of the directive

Components no longer have a blanket exclusion from the directive.

Article 1 (b) of the EMC Directive defines "Apparatus" ("Apparatus" means any finished appliance, or combination thereof made commercially available as a single functional unit intended for the end user, and liable to generate electromagnetic disturbance, or the performance of which is liable to be affected by such disturbance.). According to article 2.2 "components/sub-assemblies" and "mobile installations" are deemed to be an apparatus, under certain conditions.

Power supplies, PCI cards, Disk drives, electric motors and PLC’s are considered as apparatus and the directive must be applied.

Resistors, capacitors, relays etc are not considered as apparatus and are excluded

Labelling & Traceability

Apparatus must be labelled with Type, Batch Serial Number or any other information allowing unique identification and clearly correlating with the Declaration of Conformity.

The name and address of the manufacture must be provided in documentation and if applicable, the name of the EC representative or the person responsible for placing the product on the market.

Special conditions for installation or use pertinent to EMC must be included in documentation (Eg earthing requirements or connection of screened cables).

EMC Assessment Report.

The manufacturer is responsible for producing an ‘EMC Assessment Report’

(Normally test report applying harmonised standards but may include other considerations / justifications)

There is no requirement to use a Notified Body, but where a manufacturer chooses to use one, their statement of opinion must be included in the EMC assessment report.

Declarations of Conformity must refer to the new directive from 20 July 2007, since the old directive no longer exists, it is no longer possible to comply with it.

Notified bodies

The Competent bodies, appointed under directive 89/336/EC will cease to exist on 20 July, and will be replaced by the new Notified Bodies appointed in accordance with 2004/108/EC.

The use of a notified body is optional, but if used, their conclusions must be included in the EMC assessment report.

Fixed Installations

"Fixed installation" means a particular combination of several types of Apparatus and, where applicable, other devices, which are assembled, installed and intended to be used permanently at a predefined location

By their nature fixed installations will not be subject to the need for free movement within the European Community. Therefore they are not subject to the requirements for CE marking or the need for a declaration of conformity or for a formal EMC assessment before installation (DTI draft guidelines)

It is necessary to be able to demonstrate that good EMC engineering practice has been applied in the installation. It is recommended that records of EMC measures be maintained.

The directive describes a ‘Responsible Person’ who is responsible for the compliance of the installation.

Changes to Standards

Immunity

The industrial Immunity standard (EN61000-6-2:2005) has just changed it’s requirements for RF Immunity Testing to cover the frequency band from 150kHz to 2.7GHz (Previously 150kHz to 1GHz).

Industrial products must comply with these new requirements by 01 June 2008 if they are to remain on the EU market.

The standard for Laboratory, Process Control and Measurement Equipment (EN61326: 2006) also extends the frequency range for radiated immunity testing to 3GHz. The date of withdrawal of conflicting standards is 01 February 2009.

All of the other product and generic standards are expected to follow suit, whilst the implementation timescales may be different, the requirements will be similar. 

There are also minor changes to the requirements for Voltage dips and interruptions, making the industrial standard slightly more onerous than it was previously.

Emissions

A precedent has now been set for the long overdue change in radiated emission limits to cover frequencies above 1GHz. The Information technology standard EN55022: 2006, has now been published, prescribing Radiated Emissions limits up to a maximum of 6GHz for equipment utilising high clock frequencies. Conflicting standards have to be withdrawn, and equipment on the market must comply by 01 October 2009.

The following table summarises the upper test frequency based on the highest frequency present within the apparatus.

     Highest Internal Frequency                   Upper Test frequency

            F < 108MHz                                                   1GHz

            108MHz < F < 500MHz                                  2GHz

            500MHz < F < 1GHz                                      5GHz

             F > 1GHz                                                      6GHz or 5xF

 

All of the Generic and Product Specific Emission Standards are expected to change in the same way.

It should also be noted that the new Standards  require that all products be tested for immunity and that the pass criteria for immunity is specified by the Standard, not the manufacturer (some manufacturers in the past decided that it did not matter if there equipment malfunctioned during immunity testing and thus omitted to do any immunity testing).
Do NOT leave it to late to start the up-date process, the longer you leave it, the more it is likely to cost and the longer it will take.
Contact Epsilon if you wish to discuss EMC testing at our fully compliant 3Ghz EMC Test Laboratory.
 
 


ON-LINE COMPLIANCE MANAGEMENT

The Compliance Management System has been created to assist Epsilon customers maintain their product and quality system compliance in line mandated regulatory requirements

The system records the Standards, Directives and 3rd party Certification that products claim to be complaint with together with quality criteria needed to manufacture those products (for example, and ATEX Quality Module or lodged Technical Dossier). This information is checked and entered by Epsilon so that on the day of entry, you are assured that you meet the necessary criteria to be able to put your product on the market in the EU under the ATEX and other CE Directives on the day of entry.

The system can also generate a current template ‘Declarations of Conformity’ for each product at the push of a button that can be printed for use.

Epsilon monitors all Directives and Standards on our system for changes. If something changes that affects your product, you are notified automatically and actions that require attention are highlighted in your product list. When Directives or Standards are amended or withdrawn, Epsilon will attach a guidance document informing you of what you need to do. The system will also notify you automatically if your Quality Assurance requires attention.

For minor actions that require no testing, Epsilon can add ‘concessions’ to your certificates or files that allow you to demonstrate that you continue to meet the ‘state of the art’ requirements without having to update certificates or files manually. The concession service can also be used for small changes that you make to your products that do not require a full variation. The concession service is free whilst subscribed to the Compliance Management System.

Each Epsilon customer has a unique log in and password to access information on their company and products. This can be changed under the ‘Company Details’ menu.

Initial View

The initial view will show all current records for your company with a search function to find what you need quickly. Use the drop downs in the search function to select a criteria for search (a full Boolean search feature is available to narrow the search).

Product View

Clicking ‘View’ to the left of any listed product will take you to the product details.

The main page tab will show subscription details, and any required Quality Modules for the product. 

The Directives tab will show the Directives that are currently applied to this product, it will also show any superseded Directives for the product. The Standards tab will show the Standards that are currently applied to this product, it will also show any superseded Standards for the product. Other applied criteria allows recording and monitoring of other mandated regulations (such as the Noise Directive). Under ‘Certificates’, the current Certificates used to demonstrate compliance are recorded. Certificate details can be viewed to see the current variation level and any concessions permitted on the certificate.

General Information

The system can be searched to find information on the current Directives and Standards even if they are not currently used for your products. The system is populated with the most frequently required Directives and Standards including update histories, downloadable Directive details and the current list of Harmonised ATEX Standards. This system is also populated with the most frequently used CE Standards.

Technical Interpretations

Under Technical Interpretations you can search for the latest technical guidance and Standards interpretations from Epsilon and the European Notified Body Group.

On-Line Expert

On this page you can search for answers to your technical and general questions, Epsilon will frequently update this section to form a true ‘expert’ system that should be your first port of call for technical questions. If this does not answer your question you can ask us directly using the on-line ‘contact us’ form.

Additional Information on ATEX Compliance 

ATEX is a CE marking Directive, and as such, compliance is demonstrated by a Declaration of Conformity and a Technical File or Dossier. Within the Technical Dossier there will often be the requirement to have a ‘Notified Body’ Certificate (for example, Zone 0 or 1 Electrical Equipment), but this alone may not meet the requirements for the Technical Dossier and ultimately, the manufacturer always ‘self declares’ that they meet ATEX, even with the support of a Notified Body Certificate.

It is important to note that the declaration is made on the day the product is placed on the market, not the day that the certificate was issued or the technical dossier was created, and the technical dossier must reflect the ‘state of the art’ (current practice) on the day the item was placed on the market.

Annex II of the directive “The Essential Health and Safety Requirements” (EHSRs) makes the following statement:

Technological knowledge, which can change rapidly, must be taken into account as far as possible and be utilized immediately.

‘Technological knowledge”, is generally based on the European standards that have been given “Harmonised” status for the directive by having their number published in the Official Journal of the European Communities (OJEC)

The Declaration of Conformity is required to list the use of harmonized standards (and other standards). It therefore follows that, throughout the lifetime of a product range, the relevant declaration may have to change to reflect withdrawn and updated Standards.

It is explicitly stated that withdrawn or superseded Standards should not be used to ‘presume’ conformity with ATEX. With that in mind, the ‘minimum’ requirement for changes in Standards listed in Declarations and/or Certificates will be to check to see if the changes affect the initial assumption of conformity (have there been any changes that may affect the construction, assessment or testing of the product). This assessment must be recorded in your technical dossier and the Declaration of Conformity.

If any change affects the test or assessment required by a Notified Body, then you should seek a variation to your certificate to include these changes and align your certificate with the Declaration of Conformity. Indeed, even if the changes do not affect certification, you may find the lack of alignment between the Declaration and the Certificate unacceptable to buyers, who are checking new products against the ‘current’ list of Harmonised Standards.

 
Existing Epsilon customers will be sent an address and log in shortly.
Contact Epsilon for further details and a demonstration password and username
 
 
New version of the LVD published

EMC DirectiveThe codified version of the Low Voltage Directive has been published in the OJEU L374 (27 December). This means that as from the16th of January, the old 73/23/ECC directive is repealed and the new Directive 2006/95/EC of 12 December 2006 on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits enters into force. In practice, this means that:

1.Member States are not obliged to transpose this new directive, whose content does not alter the substance of the provisions contained in the act that has been codified

2.Products placed on the market before the 16/01/2007 are of course unaffected

3.For products placed on the market after the 16/01/2007: all explicit references to the LVD in the DoC, instructions for use, technical file, etc., are expected to be replaced by references to the new Directive 2006/95/EC.
However, as there is no substantial change to the provisions of the Directive, the European Commission and Member States representatives confirmed at the last LVD working party of 15/11/2006 that the above mentioned changes would be enforced in a reasonable manner, taking into account the principle of proportionality and the need to avoid creating unnecessary costs for manufacturers. For instance, it would be unreasonable to require manufacturers to change all references to the LVD in the existing documents attached to products which have already been placed on the market under Directive 73/23/EEC and are expected to continue to be placed on the market after the 16/01/2007, for which documents may have already been printed in large quantities, taking into account future production as well.
 
 
Click here to download the new Directive.
 

 

Epsilon to run FREE training and update seminars for UK ATEX Manufacturers.

Epsilon will be providing several free training sessions on how to achieve cost effective ATEX certification and understanding CE Marking. 8 Free half day courses will be run throughout 2007.

Epsilon will also be providing six monthly ATEX update seminars free of charge to all ATEX manufacturers advising on the current 'state of the art' methodologies, news from technical committees and the Notified Body groups and other related matters.

On line booking will be available from January 2007. Contact us if you require further information.

 

More free 'Compliance Update' seminars to be run starting in Houston, Texas.

Due to overwhelming demand, Epsilon is providing another series of update seminars in Houston, Texas. The seminars, starting from November 5th, currently have over 130 delegates attending  from some of the most prestigious (and busy!) companies in Houston. The seminars will cover:

CE Marking of Assemblies (PED, LVD, EMC and ATEX)
ATEX and Protective Systems
An update on the latest European and IEC Standards
An update on new or changing European Directives
An update on the current surveillance (checking) of products for CE and ATEX
Open Questions

The seminars are being run through Epsilon Inc., our US Incorporated Company that is focused on providing the best support for North American companies available from any CE, IEC and ATEX Notified Body. Epsilon has had offices in  Houston for over seven years,  and even has a  company apartment for our visiting Engineers from Epsilon in the UK (who frequently relocate to Houston for the duration of projects to work directly with our customers). We understand the products, markets and needs of our customers in Houston having CE Marked, IEC and ATEX Certified most items of Oil and Gas equipment including top drives, BOP's, pipe handling equipment, turbines and control rooms including on site certification of equipment offshore oil rigs and FSPO's.

Additional seminars are being held in Aberdeen, New York, Calgary and Singapore in 2007. Please contact us if you would like to attend an open seminar or have one  in-house at  your company (for example, as a lunch and learn).

 

Free Seminar on ATEX and CE Changes in Houston, Texas.....Download the overheads

ATEX seminarEpsilon recently gave several seminars in Houston Texas on the forthcoming changes in ATEX and other CE Marking Directives. The  1/2 day open courses were fully booked with 50+ delegates per course. Several 'in house' courses were also run for companies such as Schlumberger.

The overheads for the course are now being provided FREE  Click here to open the update course in PDF.

 

EMC Directive to be replaced...many existing products will require re-testing

EMC DirectiveEMC Standards and Directive are changing…many existing products will require re-testing. New EMC Standards are being produced that will require many products to be retested to higher frequencies if you wish to continue to sell them in Europe. The new higher frequency tests reflect the growing use of higher frequency communication technologies, including Bluetooth and Wi-Fi. The EMC directive is also being replaced and this may require changes in your compliance documentation. Click the picture to see the new EMC directive in full (PDF)

More information can be found in the free seminar update file.