Regulatory Testing and Certifications

The Wide World of Regulatory Testing and Certifications for New Product Introductions

The average consumer product today has a dozen safety and certification marks, stamps, or seals that most consumers do not understand. These marks, when appropriately used, can indicate a great deal about the quality and safety of the product; they show that the product has been independently tested to verify its conformance to industry standards and regulations. Some markings are voluntary while others, in certain cases, are mandatory. Even if they are not mandatory, they can make the difference between acceptance and rejection when going through customs. Many times the success of a product is contingent on its regulatory testing and certifications. However, learning which certifications are needed and how to receive them can seem overwhelming at first.

One of the first steps during product design should be researching and working toward certification compliance. It is much simpler to implement certain criteria at the start of project than it is to try to change or retrofit the project after the fact. Once the product objective has been defined, you should begin working with the appropriate agencies to start the certification process. This article will elaborate on some of the more well known certifications, what they represent, and in what countries they are accepted.

UL

One of the most widely known and respected marks is that of Underwriter Laboratories, or UL. UL was established in 1894 to find out if products being developed were safe, which remains the company’s primary goal to this day. Underwriter Laboratories has expanded into many different fields, ranging from consumer products to construction, but its focus is still safety in each of those fields. UL can certify products at the component level by giving the “Recognized Component Mark,” which indicates that the component is certified but not necessarily the end product. This is an important distinction because UL-certified PCB manufacturers often will stamp their PCBs with the “Recognized Component Mark,” but that does not mean that the overall project is UL listed. All UL markings have a number near the mark, which is searchable in the UL database.

Before working with UL, it is advisable to review the different fields options and select the one that best fits your product. This may change once you start the process, but it will help you understand what UL looks for and how it divides fields. After contacting UL, you will be assigned an account manager who will help you through the process. One of the first questions that a UL account manager will ask is where the product will be marketed. UL has collaborated with similar safety certifications around the world and can provide special markings to indicate that your product has been certified in the US, Canada, China, as well as a variety of countries in Europe and South America. Once the locations have been selected, the account manager will create an overview of the process and discuss what will come next. At this stage, UL provides a cost estimate and you can decide whether or not to continue in the certification process. Once you commit to the process, help is available every step of the way to make sure that your product reaches the standards set forth by UL. You can expect to have at least one physical visit from a UL representative to view your facilities and make sure the process is being followed correctly. Ultimately, you will receive a certification certificate and a corresponding number that end users can use to confirm that the product is legitimately UL-certified.

While UL is a non-profit organization and a Nationally Recognized Testing Laboratory (NRTL) by OSHA, it is not a government agency, meaning certification is not mandatory. Although this testing is not mandatory in general, there are certain markets, organizations, and even municipalities that require a UL mark on selected product categories. For example, if your product deals with hazardous energy in any way—whether it is electricity, gas, or steam—it is more likely that a UL listing will be required or strongly recommended.

CE

The CE mark, or mark of the Conformité Européenne, is not an organization but simply a mark that indicates conformance to European Union (EU) standards and limits. Depending on the type of product, these standards could be for safety, environment, or even health related certifications. Perhaps the most famous directive, RoHS is an example of the many directives that fall under CE. If a product falls under one of the CE directives, it is required to meet the EU standards before it can be distributed within the European economic area, which includes the European Union and other countries, such as Turkey and Norway, that have adopted the CE mark and made it a requirement for certain imports.

Many products do not need external review but can bear the CE mark after internal processes confirm conformance. As there is no independent review and no way to verify the legitimacy of the self-certified marks, CE cannot be depended on as a mark of safety like UL. The products that do require external review will have a “notified body” who will independently test and decide whether or not it conforms to the standards. It should be noted that UL is one of the testing agencies allowed to perform these conformance tests. If the product passes, then an identification number will accompany the mark that can be verified online. With either the internal or external review, manufacturers and distributors need to maintain the proper paperwork indicating that due diligence was taken. This needs to be provided upon demand and, if it is found that the product does not actually qualify, the penalties can include civil and criminal charges against the company and its officers.

With the CE mark, the first steps are the simplest. Begin by searching for the different directives and note if your product fits under any of the categories. For electronics manufacturers, it is likely that at least the RoHS 2 directive will be applicable, with the low voltage directive and the electromagnetic compatibility (EMC) directive being applicable as well. Once all of the applicable directives have been identified, you will then need to determine if a notified body must be involved in the certification process or if you can self-certify. Even if self-certification is permitted, you can use a notified body to perform an external certification if so desired. If self-certifying, the next step is to confirm that your product conforms to the applicable directives, and if not, make the appropriate changes. Once the product is in conformance, you will then document the conformance using the EC Declaration of Conformity along with any supporting technical reports. Once these steps have been completed, you can place the CE marking on the product itself or its packaging. It is in your best interests to make the marking as visible as possible in order to reduce the amount of packaging that customs will need to remove during their inspections. It is recommended to put the marking on both the final product and the packaging.

RoHS

RoHS 2,the 2011 update of the original 2003 Reduction of Hazardous Substances,sets limits on the amount of certain substances in electronics. While it is merely one of many directives in the CE, its widespread effect across the globe has made it nearly a household term. RoHS is frequently referred to as the “lead-free directive” by everyone from hobbyists to manufacturers as the move to lead-free solder is the most apparent change in the certification. However, this is inaccurate because the directive covers several other hazardous materials as well. In addition to lead, RoHS limits the amount of mercury, cadmium, hexavalent chromium (to enhance corrosion protection of solder), polybrominated biphenyls (a flame retardant used in PCBs), and polybrominated diphenyl ether (another flame retardant used in PCBs). There are a multitude of exceptions to this directive, the largest being lead-acid batteries. Fluorescent bulbs are also exempt as mercury is required to function. All medical devices were originally exempt, but with RoHS 2, the exemption has narrowed and now only certain types of medical devices are exempt. It is a good idea to check to see if your product fits under one of these exemptions and, if it doesn’t, take care to properly conform. Breaking the threshold of any of these substances will close off practically the entire European market. Oddly enough, if your product qualifies as an exemption, it can still bear the RoHS mark as it is technically in compliance.

When the RoHS directive was implemented, many engineers and designers simply switched to RoHS compliant equivalent parts without changing their designs. However, all of these hazardous substances were included in the PCBs and solder to improve performance, so their removal has, in most cases, reduced that performance. When planning on RoHS compliance, it is necessary to use not only RoHS-compliant parts and manufacturing processes, but also to analyze the effects of these changes in performances and temperatures. There may be more subtle changes needed in component selection and mounting to ensure that the PCBs are still structurally and electrically robust.

WEEE

The objective of the WEEE (Waste Electrical and Electronic Equipment) directive is to reduce the amount of electrical and electronic equipment waste. It also promotes the reuse, recycling and recovery of such wastes in order to limit the impact on landfills. To comply with WEEE regulations companies must participate in the Producer Compliance Scheme, which encourages producers and environment agencies as well a number of services to work together to recycle or reuse electrical equipment. RoHS and WEEE were published at the same time and are designed to work together, however the WEEE Directive is broader and more complex.

ETL

The ETL listed mark was originally a mark of the Electrical Testing Laboratories, founded in part by Thomas Edison in 1896. Over the years, it has absorbed many different testing laboratories and is now called the Intertek Group, a worldwide testing company based out of London. Also a Nationally Recognized Testing Laboratory by OSHA, Intertek specializes in testing consumer goods and performs a wide variety of tests. These tests are not mandatory but are performed to ensure the highest quality and safety of a product. In general, an ETL mark can be accepted as equivalent to a UL mark, but its comparative renown can be debated.

The steps to achieve ETL certification are extremely similar to UL. Upon contacting Intertek Group, you will work with an account manager who will help you through the certification process. There are variations of the ETL mark depending on the anticipated country in which your product will be marketed. Unlike the CE mark, which is not a guarantee of safety or quality, the ETL-EU mark verifies that a product has been officially tested and deemed safe and in conformance with EU laws. The serial number associated with the mark can be verified either online or via an Intertek telephone hotline. Intertek can also be used as a notified body for the CE mark.

Canadian Standards Association

The Canadian Standards Association (CSA) is similar in setup to UL and Intertek Group in that it performs tests and certifies that products meet certain criteria. Originally created to define standards after World War I, CSA helps with interoperability issues among different systems. Like other certifiers, CSA has expanded in its scope beyond its original war-time specific goals and now covers a variety of fields from consumer products to industrial equipment to environmental standards. CSA has also expanded out of Canada and is recognized in several countries in the Americas, Europe, and Asia.

While preeminently focused on safety, CSA also tests product quality and even electromagnetic interference. As with UL and ETL, CSA serializes its products and a product can be verified as truly CSA certified via an online form.

Electromagnetic Compatibility Certifications

FCC

In addition to the large number of safety and health certifications, there are also several certifications specific to the emissions of electromagnetic energy. Foremost is the Federal Communications Commission, a government organization dedicated to making wired and wireless communication available to all those living in the United States of America. As a small part of this overall goal, it organizes the wireless spectrums to reduce overlap and makes sure that unauthorized devices are not creating too much spurious RF energy in the wrong spectrum bands. To this end, the FCC requires EMC testing. For certain items, such as cell phones, these tests and the FCC mark are required before they can hit the market. However, any item that has communication lines or traces that go above 9kHz are expected to be tested, although this is not enforced unless the product is causing electromagnetic interference issues and is reported to the FCC.

The inspections for compliance are done by accredited third party vendors who will perform tests on the devices under a variety of different settings to make sure that maximum thresholds are not exceeded. If the device passes these tests, the device can bear the FCC mark and will be listed as compliant. If the device exceeds the maximum threshold, then you will need to have discussions with the testing agency to devise a way to reduce emissions.

Japan has a voluntary EMC testing and compliance mark called the VCCI, which is similar in intent to the US FCC mark. While legally and technically voluntary, it has become a de facto requirement for entrance into the Japanese market. The VCCI mark is unique in that it is required to work for both voltages and frequencies that are used in Japan. As Japan is divided with 100VAC/50 Hz on the eastern half of Japan and 110VAC/60HZ on the western half of Japan, certification has to be completed on both inputs to receive certification.

C-Tick

Australia’s and New Zealand’s equivalent to the FCC emissions standards is the C-Tick, a mandatory requirement for all products covered by Australia’s EMC regulatory arrangements. The C-Tick is only authorized for manufacturers based out of Australia or New Zealand or who use authorized agents. Testing under C-Tick is run at the standard voltages operating in Australia and New Zealand, namely 230VAC/50HZ.

BSMI

Taiwan’s Bureau of Standards, Metrology and Inspection sets the EMC standards for Taiwan, which are similar to FCC’s, in part due to the similar voltages of the USA and Taiwan. Taiwan accepts the results of testing facilities outside of the country, making it considerably easier to perform the testing. Due to Taiwan’s rising prominence in the high tech industry, this mark is becoming more prevalent and necessary.

KC

The Korea Certification (KC) mark was changed as of January 2011 from the Korea Communications Commission mark. The requirements are very similar to those in Europe, but testing is performed at 220VAC/60Hz in accordance with South Korea’s electrical infrastructure. Previously, the KC or KCC marks required in-country testing, but it has expanded to allow testing centers outside of Korea to certify products.

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