CE Declaration on Automation Equipment

[JRoss]

Can anyone give me some direction on getting a CE Declaration on piece of machinery that is being shipped from the US to Poland? The machine is a case packer, so both mechanical and electrical.
Thanks!

 

[Ken Roach]

It is... not trivial. I'm going through this process right now and after failing to get any local consultants to understand that we're building ONE machine and not a million computers, I'm meeting with another consultant in Louisville next week.

It's enough to make you want to leave the EU and scuttle the entire postwar political order.

 

[Pete.S.]

I'm pretty familiar with it. Want do you guys want to know?

One machine or a million makes no difference. You have to fulfill CE standards either way.

Primary areas for machine builders are

• the electrical side of things (electrical safety, EMC)
• machine safety
• the electrical/programming side of the safety
• documentation

Some machine types have unique safety considerations as well.
.

 

[Manglemender]

Here are a couple of links that may help.

http://www.hse.gov.uk/work-equipment-machinery/ce-mark-summary.htm
http://www.hse.gov.uk/pubns/indg270.pdf

OK, let's start with the "Technical File". A Technical file should contain all the relevant design calculations and safety documentation for the machine. It is important to keep this safely as it may be requested by a statutory body in the event of an accident and failure to produce it would not go down well.

The process starts with the design phase where risk assessments should be undertaken and documented in a the Technical File. The aim of this is to document that the machine is designed with safety in mind rather than as an afterthought. Identify potential risks and mitigating actions like adding guards.

The design of the machine should comply with the relevant standards. e.g. Most new machinery is covered by the Machinery Directive 2006/42/EC

The safety circuits need to meet one of the approved methodologies: EN13849 (Performance Level) or IEC61508 (Safety Integrity Level). Both of these methods use similar techniques to quantify the likelihood of a dangerous failure. Your risk assessment will determine what level of PL or SIL is required and your circuit designs to meet this need should be documented in your technical file.

Your completed machine should have a further risk assessment that documents you deem the completed machine to be safe as there are no unmitigated risks outstanding.

Apply a CE marked rating label with: Manufacturers name, Date, Reference number, Rated Voltage, Frequency, Current and Designed short circuit protection level.

Issue a Declaration of Conformity http://www.conformance.co.uk/info/declarationofcon.php http://www.cemarkingassociation.co.uk/declarations/


This isn't an exhaustive explanation but something to get you off the ground at least when you speak to any consultant.

Nick

 

[janner_10]

From a US Exporter POV:

http://2016.export.gov/cemark/eg_main_017287.asp

 

[JesperMP]

You must do the usual risk assessment, and verification.
The good thing is that the safety standards are universal. They are in principle the same on both sides of the atlantic. So you dont have to learn something new.
I notice though that in the US risks are more often mitigated by signs and labels, whereas in the EU risks are more often completely covered or removed. You may consider to adapt a bit towards avoiding plastering the machine with warning signs.
edit: Also, warning signs are always pictographic, never textual, because of the multitude of languages.

Make instructions for use in the local language, with safety information (tip: keep it short and to the point. For the in-depth service manual you dont have to translate it to the local language if it is intended for "experts" only).
A legally responsible person in your company must sign the Declaration of Conformity to EC Standards.
When handing over the machine to the customer, make him sign a take-over certificate stating that the machine was safe at the hand-over, that operators have been given training incl. safety instructions, that documentation has been handed over (incl. safety instructions) and that the customer is from now on responsible for the machine. This document is not a requirement, but it will save your a** if something happens. If the customer do not want to sign, despite that the machine is OK, then refuse that he use the machine.
Keep everything relevant in a "technical file". Notice that you are not obliged to hand this over to customers. It shall be immediately available though if the authorities ask for it (that is, if an accident has occurred).

All parts must be CE marked (like all parts in the US must be UL marked).

It helps if the control system are made in an EU "style". One thing that customers will expect is that control systems are servicable with power on. That means that everything is touch safe, including power bus-bars. Only if a panel section (typically the power supply entry before distributing to the power bus-bars) is not touch safe, is it a requirement that it cannot be opened with power on.

 

[Pete.S.]

When handing over the machine to the customer, make him sign a take-over certificate stating that the machine was safe at the hand-over, that operators have been given training incl. safety instructions, that documentation has been handed over (incl. safety instructions) and that the customer is from now on responsible for the machine. This document is not a requirement, but it will save your a** if something happens.

No, it will not save anyone from anything. The manufacturer is still responsible.
That is why it's the manufacturers name on the faceplate of the machine and on the CE declaration of conformity.

That said, the employer is responsible for the workers at the work place. It's the employers responsibility to make sure the machinery is used as the manufacturer has designed it and stated it's use in the users manual.

 

[JesperMP]

No, it will not save anyone from anything. The manufacturer is still responsible.
That is why it's the manufacturers name on the faceplate of the machine and on the CE declaration of conformity.

The manufacturer is responsible for that the machine is safely designed and manufactured.
But if there is an accident, and the customer claims for example that safety guards were never installed, or operators were never given instructions, then that little piece of paper will save your a**. Believe me, I have been there.
If there is an accident, and a customer can get out of court by claiming something like that, many (not all) will do so. And then you will be in trouble.
How do you prove that the machine you delivered were safe and operators were instructed ?

edit. You can make all kinds of warnings and instructions in your documentation, and then you can argue that it is the customer that must follow the documentation.
But then you must be 100% sure that your documentation covers any eventuality. It is hard to be 100%. Oh, and you have to translate all that to the local language.
And what if the machine comes not 100% assembled, but is built-up in-place ? In that case, how do you prove that everything was installed, and tested before the machine was put into operation.

This "signing of the take-over certificate" is one of the mandatory steps that my company goes through. Every time. And we do it because of hard-earned experience.

 

[Manglemender]

Something else for the OP to consider:

If you are only supplying automation equipment, say a control panel, and not the entire machine then you would issue a Declaration of Incorporation rather than a Declaration of Conformity.

This basically means that your bit is OK but the rest is up to someone else.

Nick

 

[Pete.S.]

The manufacturer is responsible for that the machine is safely designed and manufactured.
But if there is an accident, and the customer claims for example that safety guards were never installed, or operators were never given instructions, then that little piece of paper will save your a**. Believe me, I have been there.
If there is an accident, and a customer can get out of court by claiming something like that, many (not all) will do so. And then you will be in trouble.
How do you prove that the machine you delivered were safe and operators were instructed ?

edit. You can make all kinds of warnings and instructions in your documentation, and then you can argue that it is the customer that must follow the documentation.
But then you must be 100% sure that your documentation covers any eventuality. It is hard to be 100%. Oh, and you have to translate all that to the local language.
And what if the machine comes not 100% assembled, but is built-up in-place ? In that case, how do you prove that everything was installed, and tested before the machine was put into operation.

This "signing of the take-over certificate" is one of the mandatory steps that my company goes through. Every time. And we do it because of hard-earned experience.

Well, if we are are talking about machines in whatever industry you of course has to sign that everything has been delivered etc. That is part of the purchase process.

If operators needs training that is part of the purchasing as well. And usually you have an acceptance test as well.

It's just that the manufacturer can't sign over his responsibilities to the end user, no matter what you write. But I think we both agree on that.

I agree on what you say as well, as long as it is understood that the manufacturer can never get of the hook for the safety and design of the machine as well as written instructions. But it's important that the customer has installed and set up the machine as intended.

Regarding user manuals in the local language every purchase I've seen has involved the users manual in the original language (usually English) as well as translated to the local language. And the customer has to sign off on the translation.

The funny thing is that the technical file containing whatever needed to prove the manufacturers design and safety is only needed to be available for 10 years. So practically speaking it could be very hard to hold the manufacturer responsible for anything that happens after those 10 years.

 

[JRoss]

Thanks everybody! I'm looking into this for one of my customers. They build the entire machine, including the control panel, I just do the programming for them. They haven't been asked about CE marking before, so had no idea where to start. I don't either, actually, hence this thread. This at least gives us some materials to begin learning.

I'll be sure to come back with any additional questions.

 

[Pete.S.]

Thanks everybody! I'm looking into this for one of my customers. They build the entire machine, including the control panel, I just do the programming for them. They haven't been asked about CE marking before, so had no idea where to start. I don't either, actually, hence this thread. This at least gives us some materials to begin learning.

I'll be sure to come back with any additional questions.

Well, to sell to Europe they must have CE marking on their machine.

Problem is that the manufacturer also has to fulfill European regulations to put it on there.

Seconds problem is knowing which regulations and standards apply.

It is likely that they have to redesign a couple of things on their machine, both mechanical as well as electrical.

They may have to change some components as well.

Then there is some documentation and paperwork needed too. How much depends on how complex the machine is, especially from a safety standpoint.

They almost certainly have to redo their risk analysis according to ISO 12100 standard. That is need for calculations of reliability for safety components under ISO 13849 standard. This applies to the programming as well if the machine uses a programmable safety functions.