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Created On: 02 August 2012 05:30 PM
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 02 August 2012 05:30 PM
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sparkyaj

Posts: 57
Joined: 04 June 2012

I wonder if anyone can help me please? I am working along side an mechanical engineer who has been building/repairing machines all his life in the working environment.
My question is - both he and I would like to build a machine to sell to a client.

How can we apply a CE registration to it? I appreciate all materials have to be up to standards and that workmanship must not leave the machine in a dangerous condition of any shape or form.

Any guidance would be much appreciated!

Thank you.
 02 August 2012 10:56 PM
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stableford

Posts: 64
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First-I could be out of date with my knowledge.

I believe there are 2 primary routes to the CE mark.
1-A technical file is prepared by a specialist company or quality lab, who then authorize the application of the mark.
2-The technical file is prepared by the manufacturer, and applied as a self assessment.

The big thing to realize is that it must fully comply with all the standards otherwise the lawyers will have a field day.

I have come across an American weigh scale used in the water industry in the uk, on chlorination equipment that doesn't meet the requirements. A construction radio operated nearby causes the scale to drop the weight, hence signifying a leak.
 03 August 2012 08:55 AM
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iie63674

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Originally posted by: stableford

First-I could be out of date with my knowledge.



I believe there are 2 primary routes to the CE mark.

1-A technical file is prepared by a specialist company or quality lab, who then authorize the application of the mark.

2-The technical file is prepared by the manufacturer, and applied as a self assessment.



The big thing to realize is that it must fully comply with all the standards otherwise the lawyers will have a field day.



I have come across an American weigh scale used in the water industry in the uk, on chlorination equipment that doesn't meet the requirements. A construction radio operated nearby causes the scale to drop the weight, hence signifying a leak.

Not correct. There is no requirement to comply with any standards. It is the Essential Health and Safety requirements of the machinery directive (EHSRs) that have to be met.
The technical file, and the CE marking, are always the responsibility of the manufacturer, or if the manufacturer is not in the EEA his authorised representative. Some of the routes to compliance can involve an external notified body.
 04 August 2012 12:30 AM
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stableford

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Sorry my original responce maybe wasnt clear enough on some parts for some.

Again I'm not the specialist here, especially being out of country for 7 years.

I would say that regulations/directives which refer to standards and codes, means that you have to conform to the applicable european relevant standards, to be able to conform to the regulations/directive.

My interpretation of the Machinery Directive was that it was an enabling umbrella document to capture a number of standards under its overall scope, these can include PUWER, and EN61508 Functional Safety standard amoungst others including European Harmonised Standard EN ISO 13849-1:2008 "Safety of machinery - Safety-related parts of control systems".

Some of the firms I have worked with in the past have used external sources to collate the technical manual.

If you havent done this before, a good resource is the safety relay manufacturers materials such as Pilz or Omron, amoungst many others, as well as the HSE website.
 06 August 2012 09:07 AM
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iie63674

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That's a common error.
It is not necessary to follow any standards, although that's usually the simplest way of achieving compliance with the EHSRs of the Directive. Have a look at http://ec.europa.eu/enterprise...machinery/index_en.htm particularly the guidance document.
It is correct that an external company can be used to help collate the technical file, but responsibility for the contents remains with the manufacturer or his authorised representative.
The Directive isn't an enabling umbrella document, it lists a number of very specific Essential Health and Safety Requirements (EHSRs) which must be met. The manufacturer's signature on the EC Declaration of Conformity is his statement that these EHSRs have been met. He is free to use harmonised standards to help demonstrate how he has complied.

PUWER is not a standard, it is the UK implementation of another Directive, the Use of Work Equipment Directive 2009/104/EC.
 18 January 2013 05:02 PM
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pjolles

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You will need to comply with the Machinery Directive 2006/42/EC and the Electromagnetic Compatibility Directive 2004/108/EC.

Those two Directives AND the main EN Standards used will need to be listed on the Declaration of Conformity.

As stated previously: the Directives are the laws you comply with and the EN Standards tell you how to comply with the Directives.

Additionally, you will need to comply with the Low Voltage Directive 2006/95/EC but you will not list that on your Declaration of Conformity because those requirements are considered part of the Machinery Directive.

You will place the CE Mark on the system yourself - unless it is a machine subject to some special requirements (then the involvement of a Notified Body) You will be responsible for the compliance of that machine when you place it in service in the EU for a period of ten years --- so, in case somewhere down the line someone removes a guard or someone gets hurt on it you would be well advised to work with a European Third Party to ensure compliance.

Working with a European Third Party will help you make sure you have a valid CE Mark and the technical reports the third party provides will be a solid foundation to your Technical File (which the authorities can request if they question the CE Mark on your machine).

-------------------------
Peter Jolles
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 18 January 2013 09:13 PM
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gkenyon

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Originally posted by: pjolles

You will need to comply with the Machinery Directive 2006/42/EC ...
My understanding is that this is correct only if the "machine" is within the scope of "Machinery" as defined in the Directive.

Might seem pedantic, but not everything that could be called a "machine" is necessarily "Machinery" as defined in the Directive.

Also worth noting that by virtue of the legislation, "control" equipment could well be classified as "Machinery" even if it's used with "Machinery" as defined . . .

A little confusing sometimes.

-------------------------
Eur Ing Graham Kenyon CEng MIET TechIOSH
 22 January 2013 04:27 PM
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pjolles

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Originally posted by: gkenyon

Originally posted by: pjolles



You will need to comply with the Machinery Directive 2006/42/EC ...
My understanding is that this is correct only if the "machine" is within the scope of "Machinery" as defined in the Directive.



Might seem pedantic, but not everything that could be called a "machine" is necessarily "Machinery" as defined in the Directive.



Also worth noting that by virtue of the legislation, "control" equipment could well be classified as "Machinery" even if it's used with "Machinery" as defined . . .



A little confusing sometimes.


The OP is designing a machine. Therefore the Machinery Directive 2006/42/EC applies. In my experience the Machinery Directive applies if you have linked components under power but it does not stop there. A device or subassembly can be subject to requirements of the Machinery Directive for other reasons as well: most notably if it is a lifting device.

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Peter Jolles
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 22 January 2013 08:14 PM
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gkenyon

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Originally posted by: pjolles
The OP is designing a machine. Therefore the Machinery Directive 2006/42/EC applies. In my experience the Machinery Directive applies if you have linked components under power but it does not stop there. A device or subassembly can be subject to requirements of the Machinery Directive for other reasons as well: most notably if it is a lifting device.



Interesting.

The Regulations themselves contain a schedule of products which don't have to conform, i.e. are not "machinery as defined by the Regulations."

http://www.legislation.gov.uk/...8/1597/schedule/3/made

Hence the relevant provisions in BS7671 on the application of that standard to "machinery as defined", as opposed to "machines" in general.

-------------------------
Eur Ing Graham Kenyon CEng MIET TechIOSH
 24 January 2013 10:33 AM
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cblackha

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The CE Mark is applied by the manufacturer (typically) to declare that the product complies with "all applicable CE marking directive".

You need to check scope of directive (and exemptions) to determine whether a directive applies. The likely applicable directives are:
Machinery
EMC
RoHS

When assessing against machinery, you need to comply with EHSR of Annex I unless your product falls under Annex IV when you will need to use a Notified Body.

When assessing against EMC directive, Applying Harmonised Standards gives a "presumption of Conformity" - standards are typically "applied" by testing products against them, but this is not mandatory, nor is using Harmonised Standards.

There is now a Harmonised Standard for RoHS that provides guidance on information to be obtained from suppliers as part of due diligence in determining and declaring compliance.

The rules require that assessment is done and Technical File created before product is placed on the market.

Charlie
 31 January 2013 09:57 PM
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pjolles

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Originally posted by: cblackha

The CE Mark is applied by the manufacturer (typically) to declare that the product complies with "all applicable CE marking directive".



You need to check scope of directive (and exemptions) to determine whether a directive applies. The likely applicable directives are:

Machinery

EMC

RoHS



When assessing against machinery, you need to comply with EHSR of Annex I unless your product falls under Annex IV when you will need to use a Notified Body.



When assessing against EMC directive, Applying Harmonised Standards gives a "presumption of Conformity" - standards are typically "applied" by testing products against them, but this is not mandatory, nor is using Harmonised Standards.



There is now a Harmonised Standard for RoHS that provides guidance on information to be obtained from suppliers as part of due diligence in determining and declaring compliance.



The rules require that assessment is done and Technical File created before product is placed on the market.



Charlie


For industrial machinery we suggest to our customers that they acquire the information needed to comply with RoHS from the suppliers of their components. They may need to involve a lab if that is not possible but it has not been an issue. To be in compliance you will need to keep this information with your Technical File, and of course, confirm that the limits are within acceptable boundaries.

WEEE is a different story - isn't that mainly for "consumables"? By that I mean stuff like toasters and mp3 players. To comply with that you have to supply a plan or even a way to the end user for the recycling / recovery of the product at the end of its useful life.

My understanding is that this is not applicable for industrial machinery and since the OP is wearing a hard hat in his pic I think that is what he is making.

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Peter Jolles
psjolles@gmail.com
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