Compliance

It is all just EMC isn't it?
No. Product compliance covers all types of products and requirements including safety, function, acceptable failure and recycling. The EU's EMC requirements were perhaps a big learning experience for most people and so they think of EMC when compliance is mentioned.
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Isn't this just a technical barrier to trade?
This is not a question that can be answered easily. Some people would say yes and others no. Generally the question is an irrelevant distraction to a product developer. Compliance requirements are there for a reason or a number of reasons and most national requirements reflect a country's history and industrial or safety focus. If you are truly interested in taking the "technical barrier to trade" political approach, then politicians and bureaucrats may possibly help taking a case to the World Trade Organisation.
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Which standard should we use?
This depends on where you are selling and what you are selling. There are a large number of standards in the world. Standards that we have seen used relatively often are:
  • UL508 Industrial control equipment for the USA
  • UL 60950 Telecommunications - IT equipment
  • IEC 60950 Telecommunication - IT equipment
  • IEC 60601 Medical Devices
  • IEC 61010 Industrial and Lab equipment
  • IEC 60335 Household equipment
  • EN 50178 Power Equipment
  • IEC 61000 Generic EMC standards
ELMG Can help you in choosing and finding the correct standards.
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Where can my company buy standards?
Websites include British Standards, the IEC and IHS Global. Your national standards associations or companies may also sell standards.
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Who makes these standards and why?
Standards are made by people interested in the area covered by the standard. The principal reason standards are made is to reduce risk in using a product or service for the customer. Other reason's for standards are so that equipment can be interconnected, is safe and does not cause loss for insurance companies.
If there is a standard or group of standards that has large implications for your business it may be that someone from your company should be on that standards committee or attend the meetings.
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When do I get to choose the standard and when do I not?
This depends on what your product is and where you are selling it. There are a large number of European product specific standards and there are a large number of North American product specific standards. However it may be that generic standards are the best choice. Contact us for advice on chosing standards.
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Why are the European and American standards different? Can't they just make them the same?
The answer to the first question is in the different histories and legal systems of Europe and the USA. The answer to the second question is that there is considerable effort to make them the same but it does take a long time to get agreement on convergence. That said some standards may never converge.
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Are any American and European standards the same?
There are some standards that are very close. One example is IEC 60950 and UL 60950 which are very much the same.
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What is the LVD?
LVD stands for the low voltage directive. This directive sets the way in which low voltage products are to be harmonized to allow their free trade across the borders of member states of the EC. The full name for the LVD is Directive 73/23/EEC Council Directive of 19 February 1973 on the harmonisation of the laws of Member States relating to Electrical Equipment designed for use within certain voltage limits
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What is the EMC directive?
EMC stands for Electro Magnetic Compatibility and the directive attempts to ensure that products do not prevent other products from operating near them due to electro-magnetic radiation.
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What is a harmonized standard?
For the EU a harmonized standard is one that is recognized by and applicable in all the member states of the EU.
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Why should we use ELMG to do product compliance when our test lab say they can do it all for us?
This is a good question. The key difference between a test lab's service and ELMG's offering is that the test lab will not typically be involved in the design of the product. ELMG's service is typically a design and advice input at the front end to ensure that the product will comply and meet the requirements when it is tested. The ELMG input gives confidence that the product will pass the tests the first time through.
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What is a declaration of conformity?
A declaration of conformity is a declaration that the product will comply with the tests from a given standard when installed as instructed. The declaration can then be used by the purchaser to apply the CE mark without performing tests for themselves. One situation where a declaration of conformity is useful is with a product that does not provide end user functionality. The CE mark should not be applied to such a product under the EMC directive but a declaration of conformity should be provided. (The non-application of the CE mark is generally rendered moot by the application of the CE mark under some other directive - typically the LVD).
As declarations of conformity are signed by individuals there is some debate from a personal liability point of view as to whether they should be supplied as a matter of course or only when requested. This, along with who should sign them, is best discussed with legal council, your marketing department and ELMG.
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We have made a product and it sells well in NZ and Australia. What do we need to do to sell it in the USA?
It is most probable that you will need some form of third party certification. Who that third party is and what the requirements are depends on the product.
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What is UL?
UL stands for Underwriters Laboratories. It is a company that has developed standards and testing systems to ensure products are safe. The underwriters laboratories help the insurance and re-insurance industry manage the product liability risk especially for fire safety.
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What is a FUS document?
FUS stands for follow-up service. This is the mechanism by which UL check that you are continuing to produce the product in the way you said you would. If you intend to vary the components of the product it is useful to put this into the FUS document.
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What is the IEC?
IEC stands for International Electrotechnical Commission. Their website is at www.iec.ch.
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What is EN?
EN stands for Euro Norm. It means that the standard has been adopted as a European standard. As an example standards are sometimes IEC standards, EN standards and country specific standards such as British Standards so end up with mulitiple prefixes such as BS EN 60950. This is a British Standard and is also a Euro Norm.
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What is CSA?
CSA stands for the Canadian Standards Association. Their website is at www.csa.ca.
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What is CCC?
CCC stands for the China Compulsory Product Certification. It is the product compliance regime in China.
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What is C-Tick?
C Tick is the mark applied to products certified for sale in New Zealand and Australia.
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What is CE?
CE stands for Conformité Européenne, of which an English translation is European Conformity.
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What is AS/NZS?
AS/NZS stands for Australian Standard/ New Zealand Standard and indicates that the standard is acceptable in both these countries.
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What is ANSI?
ANSI stands for the American National Standards Institute.
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What is the FAA?
FAA stands for the Federal Aviation Administration. This is the US Federal agency that oversees airline and aircraft safety. It is the default regulator for the world aviation industry. Their website is at www.faa.gov.
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What is the FDA?
FDA stands for the Food and Drug Administration. This is the US Food and Drug regulator, safety and certification authority. It regulates food, drugs, medical devices, vaccines and blood products, animal food and drugs, cosmetics, radiation emitting products and products that combine these products. Their website is at www.fda.gov.
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What is the USDA?
USDA stands for the US Department of Agriculture. The USDA has jurisdiction over agriculture in the US. It provides nutrition advice, food safety education, food labeling rules, biosecurity, federal park administration and agricultural research and development. Their website is at www.usda.gov.
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Why do some markets require testing against standards and some do not?
Generally the requirements for product testing and/or certification have arisen because of events that have happened in the country(ies) and the way the legal system and economy work. Typically the higher value economies, like the US and Europe, are more heavily regulated and standardised with higher compliance requirements than lower value economies.
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What does UL Listed mean?
See the answer below.
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What is the difference between UL listed and UL recognized? Which one is best?
The key difference is that a UL Listed product is complete and can be used as is by the purchaser. A UL recognized component is a component to be used in the construction of some other product. The following is taken from UL's website:

The world of difference between UL 'Listed' and UL 'Recognized'

This information is from a printed newsletter dated 1997 and is presented here for archival purposes only. For current information, please see the main UL Mark pages at www.ul.com/mark.

A product is UL Listed if the UL Listing Mark is on the product, accompanied by the manufacturer's name, trade name, trademark or other authorized identification.

A UL Listing Mark on a product is always composed of four elements: the "UL in a circle Mark, the word "LISTED in capital letters, an alpha-numeric control number, and the product name, (e.g., "toaster and "portable lamp). Sometimes the UL file number is used as company identification. The UL Listing Mark on a product is the manufacturer's representation that samples of that complete product have been tested by UL to nationally recognized Safety Standards and found to be free from reasonably foreseeable risk of fire, electric shock and related hazards and that the product was manufactured under UL's Follow-Up Services program.

Let's assume, for example, you are looking at the installation of a spa in a health club. If you can locate a nameplate marking on the spa with the complete UL Listing Mark and the other information noted above, the spa, the "end-product, meets the requirements outlined in UL 1563, Electric Spas, Equipment Assemblies and Associated Equipment.

If you do not find a UL Listing Mark on the product, you may find, on closer examination, that some of the individual components in the spa "such as the pump, control, heater or filter" have the UL Recognized Component Mark. And some manufacturers may claim that because the components are UL Recognized, the product in which they're assembled meets all the necessary requirements. But that's not necessarily the case, because the UL Recognized Component Mark means that the component alone meets the requirements for a limited, specified use. Remember, the complete UL Listing Mark and related information on the product indicate the spa (or other end-product) is UL Listed.

UL's Component Recognition Service covers the testing and evaluation of component products that are incomplete or restricted in performance capabilities. These components will later be used in complete end-products or systems Listed by UL. UL's Component Recognition Service covers millions of components, such as plastics, wire and printed wiring boards, that may be used in either very specific, or a broad spectrum of end-products, or even components such as motors or power supplies. These components are not intended for separate installation in the field " they are intended for use as components of complete equipment submitted for investigation to UL.

Component/end-product compatibility is the critical link between certification of a component and certification of the end-product in which the component is used. Use of UL Recognized Components in a spa (or any other product) does not mean the spa itself is UL Listed.

From the above it is clear that neither UL Listing nor UL recognition is necessarily best. They are different marks indicating different things.
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If I use a UL recognized component how does this help me with getting a product UL Listed?
A UL recognized component is recognized by UL as being suitable in certain conditions which were specified and tested in order to get the UL recognized component status. If you use the recognized component within these conditions in a product you wish to have UL Listed then the performance of that component will, most likely, be assumed to be suitable by UL test engineers.
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Can I use a non-UL-recognized component even if a recognized component is available?
Yes. The main reason for doing this is that non-recognized components can be less expensive. A non-recognized component will, most likely, be investigated and tested more thoroughly by the UL test engineer.
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What are the most common standards?
Standards that we have seen used relatively often are:
  • UL508 Industrial control equipment for the USA
  • UL 60950 Telecommunications - IT equipment
  • IEC 60950 Telecommunication - IT equipment
  • IEC 60601 Medical Devices
  • IEC 61010 Industrial Measurement and Lab equipment
  • IEC 60335 Household equipment
  • EN 50178 Power Equipment
  • IEC 61000 Generic EMC standards
ELMG can help you in finding and suggesting the correct standards.
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What is the NEC? How is it relevant to selling products in the USA?
The NEC is the National Electrical Code. It is the National Fire Prevention Association standard 70 or NFPA 70. If your product is sold in the US and connected to the electrical mains then an understanding of the NEC is very useful. You can get the NEC from Amazon or any good book seller.
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Currently our company sells non UL marked product into the USA. It goes pretty well. Should we not do this?
Without looking at the product ELMG Limited is not prepared to comment.
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What is a UL shop?
If a panel product is tested by UL using UL508 then it may be possible to have a company with "UL Listed panel shop" status build it and because UL know the company the inspection required is typically less.
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What is the best advice for a company considering or moving toward getting product tested and marked for CE, UL or any other mark?
The most surprising thing about the process is that it creates a structural organisational change and power shift in the organisation. Typically design engineers feel threatened by it as they now must somehow obey new rules enforced by an external third party. Research and development managers are put under pressure to reduce the number of development cycles as each cycle requires re-testing. Executives will feel that some of the flexibility in the way the company operates is gone. In terms of advice for achieving good results:
1. Understand why your company needs to do this. This is typically a market requirement. Clarify this as much as possible.
2. Get some external help. There are HR reasons for this along with technical ones.
3. Make a plan.
4. Assess where it has impacts in your business. Change control is a typical area but there are others also.
5. Get ready for people to react negatively and have an HR plan to deal with it.
6. Recognize what it will cost.
7. Get some external help and use them appropriately.
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Are standards deliberately written to be incomprehensible?
The first time you read a standard you may conclude that they are. Standards have a specific style, language and body of existing knowledge that is assumed. Generally product specific standards will refer to generic standards and a working knowledge of the generic standard is assumed.
The two keys to successfully reading and understanding standards are: accepting that the standard maker has authority (resistance is truly futile); and understanding the intention of the standard, including why it was written.
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Is there a way to simplify what the engineers need to know about the standards?
Yes. A good approach that we have seen work well is the "How we do it here" approach. The standard requirements are translated into requirements for your specific product range and codified in tables and internal reference documents. One situation where this is especially effective is where the requirements of multiple standards from two different places, typically the EU and the US, must be simultaneously designed into the product.
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What is a PWB?
UL refer to printed circuit boards as printed wiring boards. See www.ul.com/pwb.
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What is a field wiring terminal?
A field wiring terminal is a terminal that is wired in the field. That is by an installer or technician after the product has left the factory.
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I plan to design a product, get UL to test it and then change it a bit where it fails and get UL to test it again. Is this a good plan?
In short, no. It is unlikely that this approach will lead to successful product with a reasonable development cost or in a reasonable time. The time to market will be long and the cost of UL personnel time and lab testing time will be expensive. The approach may also annoy your UL test engineer. Better to design it correctly, involve UL early, test it once, then put it on the market and make lots of money.
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