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American equivalent for European CE ???

09/26/2008 3:55 AM

Hi,

My (European) company wants to sell a new self designed and built product in the US. In Europe we have to comply with CE regulations.

Is there an American equivalent for CE ???

Regards,

Rik.

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#1

Re: American equivalent for European CE ???

09/26/2008 7:46 AM

Could this be what you are looking for? Underwriters Laboratories

http://www.ul.com/

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#2
In reply to #1

Re: American equivalent for European CE ???

09/27/2008 12:44 AM

Not exactly. UL is one of the notified bodies. You may approach FM or CSA also. All these NBs have thier own standards (UL is derivation of IEC) Every thing depends on the tests. For Ex approvals all these three laboratories can certify the product, and acceptable in US. (Though FM standards are little more stringent than other two) For low voltage directive equivalent (IEC61010) all three can certify. For EMI EMC (EN60079-XX) probably you need to approach other laboratories. These three do not cater for this test. Parallel to PED, US needs U stamp. For Canada, you need CRN which is given by TSSA or ABBA etc. US has nothing similar to CE, which covers various aspects like all EU directives. AND now a days almost all EU NBs can certify product for USA also, for various requirements, though no mark like CE is needed in USA.

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#3

Re: American equivalent for European CE ???

09/27/2008 9:42 AM

Well...I think you are looking for FDA (U.S. Food and Drugs Administration). Every new product in U.S. market has to be registered on its database (not just food, drugs, but equipment, etc.). To be accepted, you must have all requirements, e.g., if you are a Medical Equipment Manufacturer, must have ISO13485 and your product must meet IEC60601-1.

So, you will have the FDA logo on your product (as it is with CE), and you will be able to be in the USA.

Have a look at www.fda.gov and try to call them. They might have better info...we have done it during two years and I guess that the path you should follow will be quicker due to your CE logo.

Best regards,

Oscar Blanco

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#5
In reply to #3

Re: American equivalent for European CE ???

09/27/2008 11:00 AM

Perhaps this is true for medical equipment, but it certainly is not required for general equipment.

Tad

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#4

Re: American equivalent for European CE ???

09/27/2008 10:04 AM

The technique used depends on the type of equipment and the volume. Large equipment sold at low volume can use special inspections and modifications to adapt them to local regulations. We do this for one of our European supplier.

Large volume low cost equipment are likely to need some re-design to comply with NA standards. Then CSA, UL ... will look at them and if accepted, give you a listing number for the product or similar approval.

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#6

Re: American equivalent for European CE ???

09/29/2008 12:15 PM

The company in which I work and designed and built a standard family of automated test equipment that was to be used at various suppliers of equipment that is to be used in the JSF. Some of these suppliers were in Europe. Before the tester could be shipped to Europe, they had to have a certifying company come and evaluate and test the tester to give it a CE certificate. US standards may be equivalent to CE but if the product is going to be used in Europe, it has to have a CE sticker on it.

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gsuhas (1); Kyoto (1); marcot (1); Oscar Blanco (1); ozzb (1); Tad (1)

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