Are you looking at getting your product to market? We can help you with all your certification requirements. Contact us to know more.
Understanding Current Certification/Compliance Requirements for Electronic/Electrical Hardware Devices
Most Electronic and Electrical devices or products require compliance to multiple certifications/approval (Safety, Emissions and Functional) standards to be marketed in various geographic regions. The Certification & Compliance requirements for a device is specific to its function and the countries/regions where they will be marketed.
A device that is undergoing testing is usually termed as an EUT (Equipment Under Test). Hence equipment and device or product will be used interchangeably in this article.
The cost and time required to obtain all the necessary regulatory compliance certifications for your equipment is an important engineering consideration in the product development lifecycle. The process of identifying and applying for Certifications is one of the most overlooked activities when it comes to planning a new product launch strategy. However, it is essential to understand and identify all the necessary certification requirements from the very beginning.
This article will explain the regulatory compliance certifications necessary in Canada, United States, and the European Union. Other countries and regions have very similar standards for regulatory certifications; however, they insist that all equipment inspection, review, and testing be performed in accredited laboratories in their country only.
A) EMC/EMI Compliance
Innovation, Science & Economic Development (ISED)
ISED approval is required in Canada for all electronic equipment that have oscillators in the 9 kHz to 3 THz (3.000 GHz) range, that intentionally (Intentional Radiators) and not intentionally (Unintentional Radiators) emit Radio Frequency waves.
Federal Communications Commission (FCC)
FCC certification is required in the United States for all electronic equipment that oscillate at 9 kHz to 3 THz (3.000 GHz), that intentionally (Intentional Radiators) and not intentionally (Unintentional Radiators) emit Radio Frequency waves.
In Europe, Unintentional Radiators must comply with the EMC Directive # 2014/30/EU, while Intentional Radiators must comply with the Radio Equipment Directive (RED) # 2014/53/EU.
The Unintentional Radiator is classified as equipment that does not intentionally emit radio frequency waves. Most high frequency digital or analog electronic equipment may inadvertently emit some level of electromagnetic radiation.
- FCC requirements for Unintentional Radiators are available online under US Title 47 CFR Chapter I/Subchapter A, Part 15 subpart B starting at 15.101. Part 15 can be viewed here.
- FCC requirements for Industrial, Scientific, and Medical (ISM) Equipment are available online under US Title 47 CFR Chapter I/Subchapter A, Part 18 subpart C, starting at 18.301
- In Canada, ISED requirements for AV/IT Unintentional radiators are under ISED # ICES-003 Issue 7 October 2020 for Information Technology Equipment, and can be downloaded here.
- In Canada, ISED requirements for Industrial, Scientific, and Medical (ISM) Equipment are under ISED# ICES-001 Issue 5 July 2020 for ISM equipment, and can be downloaded online.
In Europe, the European Commission designates requires compliance to the following standards:
- Audio/Video and Information Technology (AV/IT) equipment: IEC CISPR 32 (Electromagnetic compatibility of multimedia equipment - Emissions requirements) and IEC CISPR 35 (Electromagnetic compatibility of multimedia equipment - Immunity requirements.
- For Industrial, Scientific, and Medical (ISM) equipment: IEC CISPR 11 (Industrial, scientific, and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement).
- For household appliances, electric tools, and similar apparatus: IEC CISPR 14 for EM compatibility.
Japan, South Korea, Australia/New Zealand, Taiwan, China, and other Asian countries have either adopted versions of the above IEC standards or incorporated relevant sections into their harmonized standard. The emission limits are similar but are somewhat stricter with regards to RF emissions at some frequencies.
For all intents and purposes, these regulations include almost all electronic equipment, since very few equipment can run at frequencies less than 9 kHz.
However, there are exceptions, if your electronic equipment (Unintentional Radiator) meets the criteria of ‘Exempted Devices’ per Title 47 CFR Part 15.103, it may be exempted from FCC certification, if it does not cause harmful disturbances to nearby very sensitive high speed/RF equipment.
For example, some digital circuits can run at frequencies below 9 kHz, and as such they may qualify for an exemption. However, even then you need to make sure that none of the higher frequency harmonics exceed the standard limits.
As a rule of thumb, electronic equipment 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 equipment emissions do not interfere with wireless communication and other electronic equipment’s functionality.
In the USA and Canada, there are two classes of FCC/ISED equipment testing: Class A has higher emission limits for equipment that will be used in industrial, institutional, or commercial applications. Class B is for consumer equipment and requires stricter testing due to reduced emission limits. For Class A & B equipment, an accredited laboratory will have a calibrated semi- or full- anechoic chamber and calibrated test equipment for measuring electromagnetic emissions.
Regardless of the type or classification of your equipment, if it is AC powered it must also meet conducted emissions limits. This applies whether an equipment is directly powered from the mains, or whether it is DC powered from an AC adapter that is supplied from the mains. Most conducted emissions can be easily suppressed using appropriate ferrite cores externally, or Common-mode chokes internally mounted on the AC or DC power input module.
ISED Canada and FCC classify an intentional radiator as any equipment that intentionally transmits radio frequency (RF) waves (also called more broadly electromagnetic radiation). A cellular smart phone, tablet, Laptop, Wi-Fi router, Bluetooth enabled or sub-1GHZ radio transceiver equipment are examples of intentional radiators.
- FCC requirements for Intentional radiators are available online under US Title 47 CFR Chapter I/Subchapter A, Part 15 subpart C, starting at 15.201
- In Canada, ISED general requirements for Intentional radiators are under ISED # RSP-100 Issue 12 August 2019 for Information Technology Equipment, and can be download online.
- In Europe, EC requirements and applicable standards for Intentional radiators under the RED directive can be found online.
Intentional radiator equipment certification requires more review, testing and approval time than unintentional radiator equipment. You must review at what frequency(ies) your equipment will function. Depending on the countries where your equipment will be put onto the market, you may not be able to certify some devices that operate at certain frequencies, as they are licensed for other commercial wireless uses.
For example, some wireless sensor networks operate at sub-1 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.
To reduce the certification costs for wireless functions in your equipment it is recommended to use pre-certified radio modules. These modules are verified to be within the limits of allowable RF power output levels. The certified RF transceiver modules are designed not to unintentionally radiate, thus preventing your equipment from radiating outside of the intended operating frequency bands.
One important thing to note is that your choice of antenna can affect certifications. Antennae 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.
Therefore, 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. This will save you considerable time-to-market and certification cost.
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 and ISED Canada 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 prototype electronic equipment will require several sessions to pass FCC, ICES and CISPR EMC emissions and EMI immunity tests.
Most entrepreneurs choose to hire a third party accredited certification testing company such as NEMKO, TUV SUD, TUV Rheinland, Intertek or SGS to perform all the necessary FCC, ISED and CISPR standards testing. Typically, you will need to make some modifications to your electronics design to pass the emissions and immunity testing. This includes adding ferrite beads, capacitors, shields, and other modifications to reduce emissions outside of the intended frequency.
SAR (Specific Absorption Rate)
While EMI is concerned with the equipment’s interference with other electronic devices, SAR is concerned with the absorption of electromagnetic energy by the human body from wireless transmitters.
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 equipment.
One of the most critical requirements of equipment operation is immunity to Electrostatic Discharge (ESD), that is easily produced and can damage your equipment. For example, the effect of walking on carpets or touching non-earth grounded equipment can produce enough static charge to damage sensitive electronic equipment.
The accepted test protocol for ESD immunity is the passing IEC 61000-4-2, with at least Level 2, but you should try to achieve Level 3 or higher.
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 is usually mitigated using transient voltage suppressors (TVS) on exposed user ports of the equipment. NeuronicWorks Inc. recommends that you allow some space on the PCB for such components, even if they might prove unnecessary in final equipment.
ESD immunity testing prevents you from encountering problems some time down the road, when a lot of equipment are already in the field. The cost of finding out that your equipment is failing at a high rate, especially after the revenue from the sales has been divested, can be devastating.
Bluetooth and other Wireless transceivers
Although not technically a certification, if your equipment incorporates Bluetooth Classic or Bluetooth Low-Energy, then you must pay a licensing fee and testing costs depending on your equipment implementation.
Bluetooth SIG is a non-profit organization that oversees the Bluetooth standard and the licensing of the Bluetooth technology trademark. You must pay them a fee to use the Bluetooth trademark. If your equipment implements Bluetooth using a pre-certified module, then you only need to pay the Bluetooth SIG licensing fee licensing fee of $8,000 USD.
However, if your equipment incorporates a custom designed, non-certified Bluetooth radio then you will also need to pay for additional testing and certification with the same group, as well as FCC and ISED certification fees.
B) Safety Compliance
UL (Underwriters Laboratories)
Certification to the recognized UL equipment standard(s) is necessary in the United States and Canada if the equipment plugs directly into an AC outlet. UL’s primary concern is with the electrical safety of your equipment.
This certification ensures that your equipment doesn’t start an electrical fire, or cause other safety hazards (e.g., electric shock, radiation exposure, mechanical injury, temperature burns, etc.) to the user/operator. There are many UL safety certification standards that are specific to the type of equipment and its intended use.
For example, one of the most common UL/CSA safety standards is the bi-national UL 62368-1/CSA C22.2 No. 62368-1 3rd edition standard for Audio/Video & information communications technology equipment. If you have medical device equipment, you will need the UL 60601-1 for Safety and UL 60601-1-2 for Emissions/Immunity standards for certification at a minimum (there are additional auxiliary standards for specific medical devices).
Also note that many UL certifications, such as UL 62368-1/CSA C22.2 No. 62368-1, will require prior UL approval/listing of safety critical parts and sub-assemblies used in the equipment.
For example, the PCB material in your equipment along with all the plastic enclosures, should meet the UL94 standard, typically UL94-V0. If your equipment contains Li-Ion batteries, these should comply with the UL 1642 standard (non-portable equipment) or UL 62133-2 / CSA C22.2 No. 62133-2 standard (portable equipment).
The European Union has its own safety certifications, but they are generally very similar to their equivalent UL standards, but are mostly based on latest released IEC standards. The European Commission requires that UL/CSA approved/certified equipment must have separate certification to multiple Directives and their latest released standards to bear the CE marking for Europe.
Many US/Canadian safety standards have been harmonized and recognized in the past few years with the existing IEC standard. One example is the IEC 62638-1 or its equivalent UL 62368-1/CSA C22.2 N0. 62368-1:2019. This harmonized standard superseded the previous UL 60950-1 /CSA C22.2 No. 60950-1 and UL60065 / CAN CSA C22.2 NO. 60065 in North America in December 2020.
Even if no one is ever injured by your equipment, obtaining appropriate safety certification to the applicable UL / CSA standards from an accredited NRTL laboratory helps you to make a better, safer equipment.
Passing these various certifications, whether mandatory or not, helps to make your equipment more robust and less likely to have any problems in the future.
You want to ensure that your equipment is safe to use under normal foreseeable uses, and prevent any damage to the device, user, or their property. Regardless of the size of your company, recovering from these types of failures can be next to impossible.
UL certification is only necessary for equipment that connect to an AC power outlet or are permanently hard wired to a single or three phase AC source. Most secondary battery powered (NiCad, Ni-MH Lithium-Ion, or Lithium-Polymer) equipment require battery charging from UL/CSA/IEC approved / certified AC powered battery charger that plugs directly into the AC electrical outlet.
However, the use of NiCad, Ni-MH Lithium-Ion, or Lithium-Polymer rechargeable batteries require additional safety certification inspection and testing to CAN /CSA C22.2 No. 62133-x/UL 62133-x standards (portable equipment) or UL 1642 (Lithium-ion or Lithium-Polymer batteries in stationary equipment).
If your equipment can be recharged by a USB charger, then the specific UL / CSA safety standard will apply to the charger itself and not necessarily on your equipment.
In this case you could either purchase a pre-certified USB charger to bundle with your equipment, or you could require the customer to supply their own USB charging source.
The same is true if your equipment 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.
Most equipment liability insurance companies, as well as most large retail chains, will require that your equipment be certified to the applicable UL / CSA Safety standard regardless of the power source. State/provincial authorities, retailers and large corporations will require it as an extra margin of safety.
This is one reason that many entrepreneurs begin selling their equipment directly to consumers via their own website. However, doing this type of e-commerce does not remove the designer/manufacturers responsibility to comply with the applicable Safety and Emissions compliance certifications required by law in each jurisdiction.
If your equipment does connect into a power source (AC, DC, battery, etc.), we suggest consulting with an electronic design house like NeuronicWorks Inc. on equipment safety certification to review the design before you proceed too far with development.
CSA (Canadian Standards Association)
CSA is the equivalent Canadian standards writing body to UL Safety Standards. NRTL accredited laboratory certification to the applicable UL and CSA standard(s) is valid in both Canada and the United States. See the above UL section for a listing for several bi-national harmonized CSA/UL Safety standards.
CE (Conformité Européenne) Marking
CE marking is required for most equipment marketed for European Union member countries and treaty affiliated European countries.
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 an equipment is a manufacturer’s declaration that the equipment complies with the health, safety, and environmental requirements in Europe. It is analogous to a combination of the UL/FCC and CSA/ISED certifications in North America. All equipment that bears the CE marking must have an up-to-date EC Declaration of Conformance document, showing all applicable EC Directives, and the EN standards applicable to the equipment listed on the document.
The following are the minimum additional EC Directive and Regulations required for application of the CE Marking:
RoHS (Restriction on Hazardous Substances)
The RoHS 2 Directive (2011/65/EU) verifies that an equipment contains no lead, or other harmful substances such as Chromium, Cadmium and Mercury. Compliance to is mandatory for equipment sold in the European Union and the RoHS regulation (SB20/SB50) is mandatory in the state of California.
Since most equipment are sold in California and/or Europe, their requirements have become the de-facto standard for environmental regulation.
Electrical/Electronic equipment designers should ensure that the component or assembly manufacturer is following the latest amendment of the RoHS 2 Directive. Note that the RoHS directive / California RoHS regulation encompasses everything in your equipment, including all electronic parts, wiring, fasteners, mechanical parts, and the enclosure (metal or plastic based).
NeuronicWorks Inc. recommends that you select only lead-free ROHS compliant components from the very beginning to avoid part damage on the PCB assembly during IR / Vapor Phase reﬂow profile soldering.
Most electronic non-military components are available only in lead-free versions. It is strongly recommended you only use lead-free components & assemblies to avoid the time-consuming exercise of reworking your Bill of Material for the manufactured equipment to be RoHS compliant.
WEEE (Waste Electrical & Electronic Equipment)
The WEEE Directive (2012/19/EU) designates safe and responsible collection, recycling, and recovery procedures for all types of electronic waste.
The WEEE directive encourages the design of electronic equipment with environmentally safe recycling and recovery in mind. This Directive works in conjunction with RoHS Directive. The RoHS Directive regulates the hazardous materials used in electronic equipment, and WEEE regulates the safe disposal of the equipment.
If your equipment 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 addition, the AC-DC wall/desktop external adapter and battery chargers must be certified to the DOE (Department of Energy) / NRCAN (National Research Council Canada) energy efficiency level VI.
C) Certification of non-IT/AV and ISM Equipment
Some types of electrical/electronic equipment will require even more certifications. For example, toys have a very comprehensive list of required Safety & Emission standards-based tests and regulations to ensure they are safe for children.
Or, if your equipment measures human body parameters, or is classified as a Medical Device, then you’ll need to follow Health Canada and FDA guidelines on what materials can be safely used, which Safety & Emissions standards are required, depending on the type and medical Classification of the equipment. In addition, all medical devices (regardless of Class) require a Risk Analysis and creation of a Risk Management File of the complete equipment at a minimum.
Because lithium batteries have the potential to cause a fire hazard (particularly certain older laptops and tablets), there are regulations on the shipment of lithium batteries (UN 38.3, etc.). The air shipment of bulk lithium batteries is especially restricted to cargo aircrafts only. Also, if your equipment contains a large Li-Ion battery, there are further restrictions based on its Equivalent Lithium Content (ELC).
D) Critical Certifications Tips
During the product design phase, you should not submit the prototypes for final certification too early, because your equipment will have to be completely retested if any design changes are made.
However, you should plan for certification during the design phase, and you should have completed pre-certification at least once when the prototypes are mature. For example, make sure to select lead-free components from the start as 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 2-3 equipment units 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 equipment to customers until the certification is completed.
Most Safety standards often require various technical documents (PCBA module schematic, bare PCB layout, wiring diagrams, internal mechanical layout, complete Bill of Material, list of Safety critical parts, custom mechanical part drawings) and commercial documents (copy of your instruction manual, other applicable printed/digital sales material), and an equipment nameplate with electrical ratings to be included along with the units to be tested. So be sure to have your manual finalized before you begin certification testing.
Many startups plan to market their equipment globally without understanding that they need capital to pay for added regulatory tests for each country / Economic Region. We at NeuronicWorks Inc. strongly recommend that you focus your initial efforts on a single country or region, and then expand slowly from there.
The USA and Canada share similar certification requirements based on harmonized bi-national standards, so in most cases you can sell your equipment 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 and Safety & Emissions standards for each country. Unless you live in Asia, marketing an equipment there will be a viable option once you are a significantly sized company with people on the ground there.
Regardless of your equipment, or the countries where it will be sold, it is strongly suggested to work with a subject matter expert knowledgeable in all the various required certifications. We have several experts in certifications at NeuronicWorks Inc. In fact, you get access to an entire team of various experts to help bring your equipment to market.