Most electronic products require multiple certifications in order to be sold. Which certifications you will need depends on your product specifics and the countries where you will market and sell it.
Don’t overlook the cost and time you will need to obtain all of the certifications necessary for your product.
Certifications may not be the most captivating subject, but it’s essential that you understand all the certifications required for your product.
We’ll mainly discuss certifications necessary in the United States, Canada, and the EU. However, other countries and regions will likely have very similar requirements.
This article was originally published on PredictableDesigns.com. Download their free cheat sheet 15 Steps to Develop Your New Electronic Hardware Product.
NOTE: This is a long, very detailed article so here’s a free PDF version of it for easy reading and future reference.
Federal Communications Commission (FCC) certification is required in the United States for all electronic products that oscillate at 9 kHz or higher.
This regulation falls under what the FCC calls “Title 47 CFR Part 15” (15th subsection of the 47th section of the Code of Federal Regulations).
In Europe, there is a similar regulation called CISPR 22. The requirements are very similar, but somewhat stricter in regards to RF emissions at some frequencies. Other countries and regions have similar regulations on electromagnetic emissions.
For all intents and purposes, these regulations include almost all electronic products, since very few products are able to run at frequencies less than 9 kHz.
However, if your product is simple enough you may be able to bypass FCC certification by purposefully designing it to operate below 9 kHz.
For example, some microcontrollers can run at frequencies below 9 kHz. Even then you need to make sure that none of the harmonics exceed the standard limits.
All electronic products with oscillating signals will emit some amount of electromagnetic radiation (i.e. radio waves), generally referred to as EMI, or ElectroMagnetic Interference. Government regulators want to make sure that product emissions don’t interfere with wireless communication.
There are two classes of FCC testing: Class A and Class B. Class A is an easier test to pass, and is intended for products that will be used in industrial applications. Class B is for consumer products and requires stricter testing.
FCC certification can be further split into two types: intentional radiator and non-intentional radiator. The category is determined by whether your product incorporates wireless capabilities such as Bluetooth, Wi-Fi, cellular, or any other type of radio transmitter.
Regardless of the type or classification of your product, if it is AC powered it must also meet conducted emissions limits. This applies whether a product is directly powered from the mains, or whether it is DC powered from an AC adapter that is supplied from the mains.
In general, conducted emissions can be easily suppressed by the use of appropriate ferrite cores. This is the lump often seen close to the DC plugs of AC adapters.
The FCC classifies an intentional radiator as any product that intentionally transmits radio frequency (RF) waves (also called more broadly electromagnetic radiation). A cellular phone or an Internet of Things (IoT) device are examples of intentional radiators.
A non-intentional radiator is classified as a product that doesn’t intentionally emit radio frequency waves. Every electronic product will unintentionally emit some level of electromagnetic radiation.
Intentional radiator certification is more involved and more expensive than non-intentional certification.
One of the first things you should consider is at what frequency will your product operate? Depending on where your product will be sold, you may not be able to certify some devices that operate at certain frequencies.
For example, some wireless sensor networks operate at sub-GHz frequencies, most likely in the unlicensed Industrial Scientific and Medical (ISM) bands.
In Europe this band is 863MHz to 870MHz, usually referred to as the 868MHz band. In North America, this ISM band is 902 MHz to 928 MHz, usually known as the 915MHz band.
A sensor network operating in the 868 MHz band is not going to get certified in North America, regardless of the radiated power. The same applies to using a 915MHz device in Europe.
One of the best ways to reduce the certification costs for wireless functions in your product is to use pre-certified radio modules. These modules are verified to be within the limits of allowable RF power output levels.
Also, they won’t unintentionally radiate, thus preventing your product from radiating outside of the intended operating frequency band.
One important thing to note is that your choice of antenna can affect certifications. Antenna gain and radiation efficiency can cause the field strength of the radiation to exceed certification limits, even though the output power of the module itself may be within limits.
This is why you should consider using pre-certified modules, with a built-in antenna if possible, for any of your wireless functions. This will save you the extra cost for intentional radiator certification, since your wireless functions will be performed by the pre-certified modules. Doing this will save you thousands of dollars.
Electromagnetic emissions are measured using a specialized testing chamber called an anechoic chamber (“an-echoic” or non-echoing) which is a specialized room designed to absorb all electromagnetic radiation. The chamber is outfitted with sensors for detecting electromagnetic emissions.
The cost to rent a testing chamber is one of the primary costs of obtaining FCC certification. The rental cost for one of these chambers can be up to $1,000 per hour.
At a minimum, each testing session will take a couple of hours. Most products require several sessions in order to pass.
Typically, you will need to make some modifications to your electronics design in order to pass the emissions testing. This includes such things as adding ferrite beads, capacitors, shields, and other modifications to reduce emissions outside of the intended frequency.
While EMI is concerned with a product’s interference with other electronic devices, SAR is concerned with the absorption of electromagnetic energy by the human body.
SAR testing is mostly applied to smartphones, tablets and laptops that have high power radio transmitters, and is something to be aware of when designing such products.
UL certification is necessary in the United States and Canada if the product plugs directly into an AC outlet. Primarily the UL is concerned with the electrical safety of your product.
This certification ensures that your product doesn’t start an electrical fire, or cause other safety issues. There are many UL certifications, each tailored to the type of product and its intended use.
For example, one of the most common UL certifications is the UL60950 for information technology equipment. If you have a medical product, you will need UL60601 certification.
Also note that many UL certifications, such as UL60950, will require prior UL certifications that apply to sub-parts of the overall product.
For example, the PCB material in your product along with all the plastic enclosures, should meet the UL94 standard, typically UL94-V0. If your product contains li-ion batteries, these should comply with the UL1642 standard.
Europe generally has its own safety certifications but they are generally very similar to their equivalent UL standards. Usually, a product that is UL-approved needs to have a separate certification to be approved for Europe.
There is a move underway to harmonize these standards. One that is very prominent is IEC62638–1 or its equivalent UL62368. This harmonized standard will supersede UL60950 in North America in late 2020.
Technically, UL certification isn’t absolutely required to sell your product in the U.S. But, if the product does plug into an AC electrical outlet you would be crazy to not get this certification.
If your product starts a fire and you don’t have UL certification, you will be held liable.
Even if no one is ever injured by your product, obtaining a UL certification helps you to make a better, safer product.
Passing these various certifications, whether mandatory or not, helps to make your product more robust and less likely to have any problems in the future.
You don’t want to have issues like Samsung’s Galaxy Note 7 phone that was constantly catching on fire. Regardless of the size of your company, recovering from these types of failures can be next to impossible.
UL certification is only necessary for products that plug into an AC power outlet. Most battery powered products need to have their battery recharged at some point with an AC power outlet.
You can avoid this UL certification requirement if your product uses a pre-certified stand-alone charger. One caveat to mention is that this applies to SELV (Safety Extra Low Voltage) circuits.
In a nutshell, that means no operator accessible parts, including the output of the AC adapter, should have a voltage higher than 42.4 VAC peak (30VAC RMS), or 60 VDC.
So, for example, if your product can be recharged by a USB charger, then the UL requirement falls on the charger itself and not necessarily on your product.
In this case you could either purchase a pre-certified USB charger to bundle with your product, or you could require the customer to supply their own USB charging source.
The same is true if your product uses a non-USB charger such as a wall adapter power supply. In this case, once again the UL certification requirement falls on the wall adapter since it plugs directly into the AC electrical outlet.
Your product will never see that AC voltage since the wall adapter converts it down to a low DC voltage.
Most product liability insurance companies, as well as most large retail chains, will require that your product be UL certified even if it doesn’t plug directly into an AC outlet. Larger retailers will require it as an extra margin of safety.
This is one reason that many entrepreneurs begin selling their product directly to consumers via their own website. Doing so may allow you to minimize the number of certifications required.
UL certification can be quite complex and confusing because of the numerous types of UL certifications.
If your product does plug directly into an AC electrical outlet then I highly suggest you bring on a UL expert to review the design before you proceed too far with development.
CSA (Canadian Standards Association) is an alternative to UL certification and is valid in both Canada and the United States.
CE marking is required for the majority of products marketed in Europe.
CE is an abbreviation for the French phrase Conformité Européenne which translates to European Conformity. Originally called an EC Mark, this certification officially became known as a CE Marking in 1993.
The CE marking on a product is a manufacturer’s declaration that the product complies with the health, safety and environmental requirements in Europe. It is quite similar to a combination of the UL and FCC certifications.
If your product contains a battery charger, and will be sold in the state of California, then it must meet the California Energy Commission (CEC) efficiency requirements.
In particular, the AC Adapter must be certified to the DOE (Department of Energy) energy efficiency level VI.
RoHS certification verifies that a product contains no lead, or other harmful substances such as Cadmium and Mercury. RoHS is necessary for products sold in the European Union and the state of California.
Since most products are sold in California and/or Europe, their requirements have become the de-facto standard for environmental regulation.
RoHS is one of the easiest and cheapest types of certifications to obtain. In fact, you may find this is something your contract manufacturer will do for you.
Just make sure that the manufacturer is following the latest amendment of the RoHS 2 standard. Please also note that RoHS encompasses everything in your product, including the screws and enclosure.
Also remember, you don’t want to mix leaded and lead-free components on the same PCB assembly as the reflow profile for each type are incompatible.
That’s why I recommend that from the very beginning you select and work with lead-free components.
Most components are available in leaded and lead-free versions. If you select leaded versions for prototyping and development you will have to go through the time consuming exercise of reworking your Bill of Material for the manufactured product to be RoHS compliant.
The Waste Electrical & Electronic Equipment (WEEE) regulation is a directive in the European Union that designates safe and responsible collection, recycling and recovery procedures for all types of electronic waste.
WEEE encourages the design of electronic products with environmentally safe recycling and recovery in mind.
This regulation works in conjunction with RoHS. RoHS regulates the hazardous materials used in electronic products, and WEEE regulates the safe disposal of the product.
ElectroStatic Discharge, or ESD, is easily produced and can damage your product. For example, the triboelectric effect of simply walking on a carpet can produce enough static charge to damage sensitive electronic equipment.
While generally not a safety issue, ESD immunity testing is highly recommended. While some ESD induced failures are immediate, others may not manifest for a while.
ESD immunity testing prevents you from encountering problems some time down the road, when a lot of products are already in the field. The cost of finding out that your products are failing at a high rate, especially after the revenue from the sales has been divested, can be devastating.
The accepted test protocol for ESD immunity is the IEC 61000–4–2, with at least Level 2 passing. However, I recommend that you aim for Level 3 or higher.
ESD is usually mitigated through the use of transient voltage suppressors (TVS) on exposed pins, such as USB, of the product. I recommend that you allow some space on the PCB for such components, even if they might prove unnecessary in final product.
Although not technically a certification, if your product incorporates Bluetooth Classic or Bluetooth Low-Energy, then you must have it tested and “certified” in order to use the Bluetooth name/logo on your product.
Bluetooth SIG is a non-profit organization that oversees the Bluetooth standard and the licensing of the Bluetooth technology trademark. You need to register and have your product tested in a certified lab.
You must also pay to use the Bluetooth trademark. Unlike the other certifications, this is an international certification.
If your product implements Bluetooth using a pre-certified module, you still need to obtain the Bluetooth SIG certification.
The normal Bluetooth SIG fee is $8,000 USD. However, they also offer a lower cost option, specifically for start-up companies, that costs only $2,500 USD. To qualify you must show financial documents proving that your annual revenue is less than $1 million dollars.
Some types of products will require even more certifications. For example, toys have a very comprehensive list of required tests and regulations to ensure they are safe for children.
Or, if your product comes into contact with food then you’ll need to follow FDA guidelines on what materials can be safely used.
Because lithium batteries have the potential to cause a fire hazard (think Samsung Galaxy Note 7), there are regulations on the shipment of lithium batteries.
The air shipment of bulk lithium batteries is especially restricted to cargo aircrafts only. Also, if your product contains a large li-ion battery, there are further restrictions based on its Equivalent Lithium Content (ELC).
You don’t want to certify your product too early, because your product will have to be completely retested if any design changes are made.
However, you should plan for certification even during the design phase. For example, make sure to select lead-free components from the start since your final design will be required to meet the RoHS standard.
Testing is expensive and takes up to a month to complete (depending on the testing facility’s queue), so you don’t want to do it more times than is necessary. Wait until you have manufacturing, and most bugs, figured out.
Then, submit a production unit for certification testing. Just be sure to plan for the time that testing and certification will take. You won’t be able to ship your product to customers until the certification is completed.
Regulations often require a copy of your instructions manual to be included along with the units to be tested. So be sure to have your manual finalized before you begin certifications testing.
Regardless of your product, or the countries where it will be sold, you would be very wise to hire someone that is an expert in all the various required certifications.
It is extremely unlikely that your design engineer(s) will have the necessary knowledge to ensure your product smoothly passes all of the various certifications required.
Many startups plan to market their product globally without understanding that they need capital to pay for added regulatory tests for each country.
I highly recommend that you focus your initial efforts on a single country or region, then expand slowly from there.
The USA and Canada share similar certification requirements so in most cases you can sell your product in both countries with a single set of certifications. The EU has the advantage that one set of certification requirements are valid for multiple countries.
Asia on the other hand tends to have separate regulations for each country. Unless you live in Asia, marketing a product there will only be a viable option once you are a significantly sized company with people on the ground there.
Although you don’t want to actually begin the certification process until you have a production-quality unit for testing, it’s still a good idea to understand all the various issues surrounding certifications.
If you need technical engineering support (including on certifications), coaching, training, and resources to help bring a hardware product to market then definitely check out the Hardware Academy.
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Author: John Teel