A company I know of wants to bring in some equipment from Europe, which contains a CE mark on the electical panels. The local government says (with support from UL) that CE marks are not sufficient, and that the panels need to be field inspected by UL.

Can anyone explain the difference? Just what is a CE mark?

Thanks

Dave,

Basically the CE Mark indicates the product meets the basic requirements of the European health, safety, and environmental agencies. Compared to UL requirements, it is less strict. Here are a couple links that have some info about CE Marking. Good luck, it's kinda' confusing...:confused:

http://www.ce-mark.com/cedoc.html

http://www.ce-marking.org/what-is-ce-marking.html

Basically the CE Mark indicates the product meets the basic requirements of the European health, safety, and environmental agencies. Compared to UL requirements, it is less strict. Here are a couple links that have some info about CE Marking. Good luck, it's kinda' confusing...
Ahh, thanks Buttercup Liver Hiney! :bigwave:

A company I know of wants to bring in some equipment from Europe, which contains a CE mark on the electical panels. The local government says (with support from UL) that CE marks are not sufficient, and that the panels need to be field inspected by UL.

Can anyone explain the difference? Just what is a CE mark?

Thanks

The CE mark is the EU's answer to UL in the US. Depending on the type of equipment you have to comply with certain EU directives. There is the Low Voltage Directive, Machinery Directive, EMC Directive and Medical device Directive. For other than the Medical Device Directive(MDD), you can self certify to the standards by testing and keeping a "Technical Construction File". For the MDD you are required to have a Notified Body in the EU that audits your QMS and Technical Construction File. I am most familiar with Medical device requirements. From your post, I'm assuming it isn't a medical device.

The UL standards for many CE marked products are harmonized with the IEC standards in the EU. If the product is CE marked, It probably will meet the UL requirements. CE is not recognized by US local agencies. They will want a UL label.

CE is not recognized by US local agencies. They will want a UL label.

I think that is the case. I would imagine that the opposite is also true. That a European agency will probably not accept a UL label either.

I think that is the case. I would imagine that the opposite is also true. That a European agency will probably not accept a UL label either.

That is correct. Also, sometimes there are different ratings for UL and CE the same device or component.

The key here is "self certify". CE marks can be placed on products after you determine that you meet the requirements. UL tests products independently and then continues to audit your manufacture to assure that you are making them to the standard that they originally tested. Changes to the product must be submitted to UL for approval (like a QS PPAP). We can debate the structure (UL isn't perfect) but I am much more comfortable leaving a UL approved lamp on all night than I am with a product that has just a CE mark.

The CE-Mark is enforced through the European Directives for REGULATED products, and carry the power of Law in Europe. People have been sent to jail for falsifying data, as it relates to product compliance to the Directives.

To the best of my knowledge, the UL Mark (for product safety), even though very prevalent in North America, is a voluntary certification. Most manufacturers like to have their product UL (and CSA) approved in order to minimize liability exposure.

It is not correct to say broadly that manufacturers can self-certify their products and apply the CE-Mark.

Depending on the Directive (MDD, ATEX, PED, In-Vitro MDD, etc...) your product has to comply with, and depending on the route (modules) one choses to demonstrate compliance, you MUST engage with a Notified Body prior to applying the CE-Mark to your product

:agree: Sidney, I agree for the industries you've cited. :truce:
However, jail notwithstanding, there are a whole lot of 120/220VAC consumer and commercial products out there with a CE mark that are self-certified. Good luck getting one on the shelf at Wal-Mart or H.H. Grainger without a UL label. Europe=can't sell without CE mark due to law=can self certify. USA, can't sell without UL mark due to lack of interest due to liability=must certify through UL. U-pick.

:thedeal:
The bottom line is the Europeans figgured out how to limit US exports without imposing direct tariffs.

I disagree. The requirements are aimed at getting rid of unsafe products from their market place.

It applies to any organization (including themselves, the Europeans) that wants to place a regulated product in Europe.

Having mechanisms in place to protect consumers is positive in my opinion.

:agree: I guess I'm being a bit cynical, but they do allow self certification for meeting the LVD and Machinery Directive as well as the EMC Directive. This does make it easier for those with an inclination towards fraudulent activities. (more cynicism) ;)

Dave B,

Coming back to the original question that triggered this thread: Who is the "local government" ?
Can they CLEARLY pinpoint the regulatory safety requirement? What exactly does it say? I am interested to know because, as I wrote previously, I thought that, in North America, the UL approval for product safety was voluntary.

So, in other words: WHERE IS THE regulatory SHALL?

There is no "shall" in the US. CE is a European Union legislative requirement. UL does not hold water in the EU. In the US individual state or local gov'ts have requirement, usually based on NEC or UL standards.

I realize that this thread is a bit elderly, but here's my 2 cents:

I have worked for a company that required notified body involvement (MDD, which encompasses the LVD and EMC Directives) and for a company that self certified to the LVD and EMC Directives. In both cases the companies I worked for used UL standards as the path to compliance. That kills 2 birds with one stone. My products have the UL mark in the US and the CE Mark for the EU. It sure beats the old days when we had to pay for UL, TUV, VDE, SPRINGA and others to claim compliance to the wide variety of electrical standards found around the world.

Far from limiting the sale of US products in the EU, I think the CE Mark makes it easier.

I realize that this thread is a bit elderly, but here's my 2 cents:

I have worked for a company that required notified body involvement (MDD, which encompasses the LVD and EMC Directives) and for a company that self certified to the LVD and EMC Directives. In both cases the companies I worked for used UL standards as the path to compliance. That kills 2 birds with one stone. My products have the UL mark in the US and the CE Mark for the EU. It sure beats the old days when we had to pay for UL, TUV, VDE, SPRINGA and others to claim compliance to the wide variety of electrical standards found around the world.

Far from limiting the sale of US products in the EU, I think the CE Mark makes it easier.
Rosie:

Although they may have used UL, the product had to meet the European standards to be marked CE. UL may have evaluated the products to the UL standards as well as the European requirements.

We use ITS to perform the same evaluation and testing that UL does. Thjey issue a report bassed on the UL standards and a report based on the european requirements.

We manufacture a medical device that must meet IEC 60601 as well as other standards for CE marking. UL now has harmonized its standard to the European IEC 60601 and calls it UL-60601. Harmonized means that the basic standard is in agreement, but there are still some differences due to local requirements.

Some of the differences in the standard are due to the fact that in Europe, they are more concerned with shock hazards and the US is more concerned with fire hazards. The reason for this is that in Europe the voltages are higher than in the US and the structures are made of stone. In the US the structures contain more wood and thus more flammable.

Our declaration of conformity for CE references the european standards. In the US there is no requirement for a declaration of conformity, only the FDA approval by way of a PMA or 510k.

Dear Al:
After reading the above messages about the voluntary nature for the UL compliance and understanding what the customer "sees" or "feels" on a product label with the UL logo part of it, I would like to "offer" my potential customers at USA (for a medical device used in clinics and hospitals) the following options:
1) Product with safety testing done in-house (ourselves), no UL logo into product's label.
2) Product with safety testing done in-house (ourselves), tested by UL field rep. and UL logo into product label (additional cost related, added to invoice per customer preference).
Please let me know if this practice is currently done by medical device manufacturers in the USA.
Regards,
LL

Please let me know if this practice is currently done by medical device manufacturers in the USA.

I've never seen it. One reason for that is that UL labeling/listing/certification is type based. Assuming that your production run will be longer than one, you're paying for an investigation that is sufficiently in-depth that they will be willing to allow you to label/list the entire run. Their investigation is of your design and manufacturing methods...not of the safety of a particular unit of product.

Some additional comments to straighten out some possibly misleading info earlier in the thread:

UL used to be both a standards promulgation agency, in a parallel position to ANSI, and a test-lab-for-hire. They had a unique and privileged position in the US regulatory world. A number of years ago, that began to change, as it was recognized that the status quo was among other things both legally questionable and unfair to UL's obscure competitors. So, ANSI took on a greater role, and some industry organizations took on new roles as standards creators. AAMI is one example.

UL is now mostly a commercial test lab, with several worthy competitors... FM, MetLab, ETL, and others. I say "mostly" because vestiges of the old system continue. A number of standards are still linked to UL, partly because even though they are nationally promulgated, UL retains certain copyright aspects, and controls aspects of their change process. ANSI/UL 94 governing flammability is an example.

Historically, UL had an extremely close relationship to the US National Fire Protection Association (NFPA), the parent organization for the US National Electrical Code (NEC), by far the most widely adopted of the many model electrical codes in the US. The NFPA also is the parent of the US Life Safety Code; the US National Fire Code; many building and architectural code elements pertaining to flammability, safe building use, emergency egress, and fire-safety construction; an extensive range of specific technical codes pertaining to safety of industrial and commercial heat-related equipment installation and operations; and most US codes and rules governing fire and emergency response services, including their equipment, training and techniques.

This close relationship historically resulted in a rigorous requirement that all materials to be used in local electrical construction work, including machine installations up to the point of local demarcation, would not be readily approved during job-completion inspections by local and state electrical and building inspectors unless they carried a UL (or, grudgingly, equivalent) Label or Listing. This also extended to electrical components used within panels and other equipment where local work had to connect; all such components had to be Listed. This requirement was uniformly enforced, so it didn't work to anyone's special benefit, and it historically resulted in a high standard for electrical construction safety in an industry that nominally had no federal-government-enforced rules.

Less strongly than the requirements for electrical construction materials, but nonetheless significantly, significant machines have tended to carry the UL label or an equivalent as well, mostly because governmental and major-institutional buyers cannot make decisions based on anecdotal evaluations and instead need evidence-based proof of suitability, which the UL (or equivalent) label provides. Many insurance companies historically have required a safety label or listing as well, as a condition for allowing installation of major equipment on premises they insure. And, local installation inspectors frequently influence such decisions as well, through institutions' facility engineers who need to maintain peaceful relations with the local authorities and "get the message" that the inspector wants any new equipment to be listed or labeled as proof of adequate safety.

There are other eccentricities to UL's standards situation. The NEC, as an exemplar of US electrical practice, requires certain electrical practices that differ from what the rest of the world does. Partly because of its very close historical relationship to the NFPA and thus to the NEC, UL applies UL-customized versions of international standards in all of its standards applications of which I'm aware, that incorporate US, not international, electrical practices. This makes sense for US installations, but sometimes is problematic for products to be exported. Also, UL's versions tend to be out of sync with international versions, since UL uses their own standards evolution process separate from everyone else's. Thus, for instance, ANSI/AAMI currently offers ES 60601-1:2005, similar to ISO 60601-1 third edition, but UL 60601-1 is based on ISO 60601-1 second edition but is significantly modified per unique UL preferences.

Thus it is misleading to say that UL (or equivalent) listing or labeling is voluntary, any more than it's mandatory. A more accurate description is that, if you want your wired-installation medical system to be readily saleable and installable in most of the US without having to deal with some degree of locally unique interface-hassle with buying committees, customer engineers, electricians, inspectors, insurance companies and other interested parties, it's sensible to just get it labeled or listed up front. That's what most first-tier medical system makers do, for instance in regard to major medical imaging systems.

Dear Al:
After reading the above messages about the voluntary nature for the UL compliance and understanding what the customer "sees" or "feels" on a product label with the UL logo part of it, I would like to "offer" my potential customers at USA (for a medical device used in clinics and hospitals) the following options:
1) Product with safety testing done in-house (ourselves), no UL logo into product's label.
2) Product with safety testing done in-house (ourselves), tested by UL field rep. and UL logo into product label (additional cost related, added to invoice per customer preference).
Please let me know if this practice is currently done by medical device manufacturers in the USA.
Regards,
LLI can't really speak for others, but I don't believe that these schemes are used.



I think users in general prefer seeing the UL on the product.
A UL Field approval only applies to the single device and cannot be applied to other devices. UL requires quarterly follow-up to verify that you haven't made changes that affect the safety of the device.

There are non NRTLs (http://www.osha.gov/dts/otpca/nrtl/) that will provide testing services so that when you submit the product to UL you can be sure it will be approved.

Actually, UL - just like FM Global, Intertek/ETL, CSA, and several others - is an ISO Guide 65 accredited product certifier.

The UL mark goes on the product, as the investigation includes rigorous testing specific to the product. It is possible to have two nearly identical products, but only one carry the UL label because on it was tested and the other not included. In such a case, every product that is approved will be able to carry the UL or ULC symbol.

As for the manufacuring process, that is documented as a part of the investigation but does not truly have serious impact until after the product certification is issued. Once the product is certified the UL field inspectors will come to the plant on a periodic - UNANNOUNCED - basis (no matter where the product is produced), and also the product must undergo periodic retesting. During the field visits, both the manufacturing process and actual production units are reviewed. Production units are compared to the certification report to assure they are still the exact same product approved, or if there are differences to see whether waivers or amendments to the report have been issued.

As to whether the UL or similar is required, that depends a bit on what the product is and where it is going, and therefore what codes and requirements actually apply.

The benefit of UL is that they are an accredited third party independent body, and not a self-declared thing.

Hope this helps.