Regulatory electronic product certification requirements can present challenges for organizations looking to design, develop and market electrical and electronic products in different countries around the world. As these requirements are primarily focused on particular products, use cases and generally the environment for which they are intended to operate, regulations and information on the subject are often difficult to understand and navigate.
Let’s take a look into the real world of 11 common compliance requirements for electrical/electronic products and gain further insights into their meanings, methodologies and test requirements.
The following electronic product certification and compliance requirements will be discussed (keep reading or hit the links below to jump to the section you prefer):
1. FCC: Federal Communications Commission (FCC)
Recognized FCC Mark:
The Federal Communications Commission (FCC) label or the FCC mark is a certification mark employed on electronic products manufactured or sold in the United States. It certifies that the electromagnetic compatibility and interference from the device is under limits approved by the Federal Communications Commission.
FCC objectives are to set applicable standards and testing measures to ensure that Radio Frequency (RF) emissions of electronic devices meet the following requirements:
Operation of an electronic device is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
Generally speaking, all electronics devices that are capable of emitting and transmitting Radio Frequency energy for the purpose of communication must adhere to The Federal Code of Regulation known as FCC Part 15, FCC.
FCC Part 15 is a federal regulation that sets limitations on the amount of electromagnetic interference a device can permissibly generate. Electronic devices that operate at a clock rate of 9kHz and above fall within the standard.
Radiated emissions: FCC Part 15 classifies RF electronic devices as the following:
Intentional radiators: These are devices that intentionally transmit and receive radio energy. Examples include products containing Wi-Fi, Zigbee, Bluetooth, RFID and Alarm systems to mention a few.
Unintentional radiators: Devices that generate radio frequencies within itself, which is then unintentionally radiated by means of conduction from the device which may cause interference or upset with other electronic devices.
Incidental radiators: Devices that generate radio frequency energy although the device is not intentionally designed to. Examples include DC motors, Mechanical light switches to mention a few.
Conducted emissions: FCC Part 15 classifies RF electronic devices as the following:
Conducted emissions, all electronic devices create electromagnetic energy and a certain portion of this energy will be conducted onto wired power and telecommunication ports connected to the device. Examples include A.C or D.C power supplies, wired Network communications, USB peripherals, Multimedia devices and Personal computers to mention a few.
Classification categories: FCC Part 15 classifies electronic devices into two categories.
FCC Class A – Reserved for devices that are intended for use in Industrial environments and nonresidential areas.
FCC Class B – Reserved for devices that are intended for use in Residential environments.
Generally speaking, electronic consumer goods fall under FCC Class B. This classification is the most stringent because they tend to operate in environments where devices are in close proximity to one another.
2. IC: Industry Canada (IC)
Recognized IC Mark:
Industry Canada (IC) is essentially Canada’s equivalent to the Federal Communications Commission (FCC). They are responsible for the certification requirements of Electronic devices and Radio equipment either manufactured or entering into the Canadian marketplace.
Generally speaking, Industry Canada applies the same test criteria as mentioned above for FCC. In fact, IC accepts FCC testing data and certification fulfillment provided that the date of completion by FCC is less than a year old. It is recommended that both applications for IC and FCC be applied for at the same time with your regulatory certifications lab, this will minimize the duplicate testing efforts, timelines and ultimately costs.
3. Radio Equipment Directive (RED): Conformité Européenne “CE RED”
Recognized CE RED Mark:
Formally known as The Radio and Telecommunications Terminal Equipment (R&TTE). The CE RED directive is responsible for the certification requirements of Electronic devices and Radio equipment either manufactured, imported or sold into the European (EU) market.
It’s important to note that RED as compared to FCC or IC characterizes other factors which otherwise were not. Most notably the addition of Health, Safety, The Low Voltage Directive (LVD) and Electromagnetic Compatibility (EMC). We will briefly describe these below.
What is considered the Health of Radio equipment? Generally speaking, this is defined as adhering to designated frequency bands with specified powers, bandwidths and duty cycles. It also encompasses efficient use of the radio spectrum. Globally, the number of devices operating within the radio spectrum has skyrocketed and regulators are tasked with ensuring proper check and balances are in place. Effectively setting boundaries, policies and regulations to derive a set of harmonized standards within the EU, Member states and neighboring countries.
Why did RED adopt the LVD? LVD identifies Health and Safety risks associated with Electrical/Electronic devices which primarily address the potential hazards of electrical shock and fire.
Why has RED adopted EMC Electrical Safety within their directives? RED requires radio equipment to have an adequate level of Electromagnetic compatibility (Disturbance and immunity). Radiated emissions, Conducted emissions and Immunity are the primary scope behind the EMC directive.
Radiated emission and immunity testing involves measuring the RF electromagnet field strength of the emissions that are generated by the device. While immunity tests the susceptibility of the device to external RF sources of electromagnetic field disturbance and its ability to operate as intended without upset.
Conducted emissions and immunity testing is performed on devices containing wired connections. Typical wired connections are network and AC or DC power ports entering or exiting the device. Wired connectivity can present emissions challenges if unwanted RF energy generated within the device is permitted to propagation either intentionally or non-intentionally through wired connections to other devices. While immunity tests the susceptibility of the device on wired ports to external sources of unwanted RF energy in addition to harmonic current emissions, voltage fluctuations and flicker.
In addition to RF Immunity, Electrostatic Discharge (ESD), Common mode Electrical Fast Transients (EFT) and Surges are some of the applicable tests of EMC on devices with wired ports. Further information is presented below under Electromagnetic Compatibility (EMC) section.
4. Conformité Européenne (CE)
Recognized CE Mark:
The Conformité Européenne (CE) Mark is defined as the European Union’s (EU) mandatory conformity marking for regulating products either manufactured, imported or sold into the (EU) market.
The presence of the CE mark, generally by means of self-declaration indicates that the product has been assessed by the manufacturer fulfilling the requirements set by the EU for Safety, Health and environmental protection. Also known as a Declaration of Conformity (DoC).
This declaration is by no means a guarantee of conformance, if requested the manufacturer, importer or person responsible for placing the product on the EU market must show appropriate technical documentation issued by an international or European Notified test body for validity.
Relevant regulations as they pertain to Electrical and Electronics devices state that product complies with the Low Voltage Directive (LVD) and Electromagnetic Compatibility (EMC). LVD has been discussed above, under the CE RED topic, while EMC is described below.
5. Electromagnetic Compatibility (EMC)
The certification mark is based on the EMC Directive 2014/30/EU. Compliance with IEC 61000-6-3 for emissions and IEC 61000-6-1 for immunity requirements applies to Electrical and Electronic devices intended for use in residential, commercial and light industrial environments. Equipment either manufactured, imported or sold into the European (EU) market are designated.
The presence of the EMC mark, generally by means of self-declaration or self-certify indicates that the product has been presumably assessed by an EU Notified test Body who will apply a CE mark to the device upon fulfilling the requirements set by the EU for Safety, Health and environmental protection. Also known as a Declaration of Conformity (DoC).
Generally, the EMC directive is a performance directive which ensures that the device does not disturb or create undesired interference or noise on other radio and telecommunications equipment.
Another very important aspect of EMC directive is to protect electrical and electronic devices from potential hazards such as Electrical fast transients, lightning strikes and electrostatic discharges while operating in their intended environment.
For a list of additional IEC standards on EMC referenced by the IEC 61000 family, please review this content online.
Common cases of failure to comply with FCC, IC, CE RED and EMC
Generally, a lack of understanding or knowledge of the applicable electronic product certification and compliance standards. Secondly, unfamiliarly of the intended environment that the device will be used.
The most common cause of radiated emissions failures is attributed to the permissible allowable limits of radio frequency (RF) and unwanted spurious emissions also known as harmonics or side-band frequencies that are outside of a transmitter’s assigned or designated channel.
The most common cause of conducted emissions failures is electromagnetic interference (EMI) disturbances generated within the device that propagates through cabling attached to the device. The most common causes of disturbances occur during the cycling ON/OFF of resistive or inductive loads. In addition, disturbances are also generated by Switch-mode power supplies and Micro-controllers.
Similarly, the same principles apply to EMC with a focus on Immunity. Electrical and Electronic devices connected through wired ports must also operate as intended within their environment. These environments in some cases can he harsh and susceptible to lightning strikes, transient voltages, surges and electrostatic discharge. Common failures include the lack of protection for these wired ports.
Design and mitigation techniques for FCC, IC, CE RED and EMC
During the initial development and design stage of any electronic device, appropriate considerations should be given to purchasing applicable standards in an effort to understand the various test criteria, methodologies, limits and permissible deviations that a device will be subjected to.
The objective is to understand the requirements and have provisions within the electronic design and Printed circuit board (PCB) to mitigate issues that may arise during certifications.
The following design and PCB recommendations should be carefully considered:
- Optimum selection of electronic components.
- Placement of sensitive RF circuits and antenna networks within the PCB.
- PCB Grounding schemes (Analog and Digital).
- PCB trace routing techniques.
- PCB board stack-up
Mitigation techniques include:
- EMI filtering devices on all Input/output signal, control and communications lines (Ferrite Beads).
- Transient, Surge and ESD protection devices on all Input/output signal and communications lines. (TVS diodes)
- Common mode filtering on D.C power and USB communications ports.
- Provisions for EMI shielding coatings
For Intentional radiators, Wi-Fi, Zigbee and Bluetooth it is suggested that you consider ready-designed System On Modules (SOM) microcontrollers with integrated radios that offer Radio certifications based on modular approval. This will greatly improve your success during the certification process and reduce your time to market.
All regulatory certification bodies will request under strict non-disclosure guidelines copies of the clients’ technical product specifications. These tend to include the following:
- Users guide and Installation manuals.
- Block diagrams.
- Product’s Bills of Materials (BOM).
- Electrical/Electronic component datasheets.
- Electrical/Electronic Schematics.
- Printed Circuit Board (PCB) Layout.
- Information pertaining to Software or Firmware for embedded products.
- Traceability information.
- Internal and external photographs of the device.
- Label design inclusive of Regulatory certification marks (FCC, CE and so forth).
- Manufacture information, which is the place where the client will manufacture the products.
- Legal company representatives.
6. UL1642, 7. UL2054, and 8. UN/DOT 38.3 For Batteries
UL 1642 is the standard for the battery safety assessment of Lithium polymer (Li-ion) Batteries (Cells) covering both rechargeable and non-rechargeable types with chemistries containing metallic lithium, lithium alloy and lithium-ion. These consist of single, multiple and Li-ion pouch cells either connected in series or parallel.
Testing criteria for UL 1642 is more in-depth as compared to UL 2054 covering a wider scope of tests which include (External short circuit, abnormal charge and overcharge, forced discharge, crush, impact, shock, vibration, heating, temperature cycling, projectile, insulation resistance and internal short circuit or internal fire test).
UL 2054 is the standard for the battery safety assessment of household and commercial batteries covering both rechargeable and non-rechargeable types. Under this standard, battery chemistries include Li-Ion, Nickel (Ni-Cad and Ni-MH), Alkaline, Carbon Zinc and Lead-acid.
Testing criteria mainly focuses on (External short circuit, abnormal charge and overcharge, forced discharge, drop, and molded casing heating tests).
The purpose is to ensure safety and how these batteries are used within in product with the intent to reduce risk of injury to persons due to fire and explosion. Coverage includes user-replacement cells and proper disposal measures.
Safety issues have been well known and documented for Li-ion battery technologies. As Li-ion cells are limited by the number of charge/discharge cycles the lithium electrolyte gets depleted. When sourcing these type of cells it’s important to ensure that your purchasing from a reputable manufacturer, one that has the proper expertise in lithium chemistry and understands your application requirements.
UN/DOT 38.3 (United Nations), (U.S Department of Transportation) UN/DOT 38.3 issues recommendations and regulates the safe worldwide transportation of lithium and Li-ion batteries. It is a self-certify standard whereby independent third party test labs is not required. However, due to liability concerns, most companies choose to perform this.
Environmental conditions such as (Low pressure, temperature cycle, vibration and shock) all constitute stresses that batteries will be exposed to during transport. If you want to ship these batteries Worldwide by Air, Vessel, Rail or Truck, all Lithium and Li-ion batteries must conform to this standard.
Lithium batteries are classified as dangerous goods and can pose a safety risk if they are not tested and packaged in accordance with transport regulations.
9. Restriction of Hazardous Substances (RoHs)
RoHs is a directive that is governed and mandated for the European Union (EU). Compliance with the EU’s RoHs directive is required for Electrical, Electronic devices either manufactured, imported or sold into the European (EU) market.
This directive sets protective measures for both people and the environment from banned (to prohibit or forbid) hazardous chemicals and substances found in both electrical and electronic devices. Hazardous chemical restrictions are (Cadmium, lead, mercury, hexavalent chromium and others to name a few).
There are various different technologies that are used to test for RoHs chemical composition. The most common include X-Ray Fluorescence Spectroscopy (XRF) while others include chemical-based testing.
10. Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)
REACH is the authorization and restriction of hazardous chemicals, a regulation of the European Union (EU). Compliance with the EU’s REACH is required for chemicals including those used to make products. Examples of these chemicals may be referenced online.
Understanding the difference between RoHs and REACH can be confusing. Generally, RoHs is the ban (to prohibit or forbid) of approximately 6 hazardous chemicals mostly product specific. Whereby, REACH generally refers to a large number of chemicals produced and used within the assembly and production of products.
The Bluetooth Special Interests Group (SIG) is the regulatory body that oversees the development of the Bluetooth standards and licensing agreements of Bluetooth technologies and trademarks. In order to release a Bluetooth end product to market, the solution needs to be qualified.
It is important to note that all products using Bluetooth technologies must comply with regulatory compliance standards applicable to the regions/countries they operate in, such as FCC, IC and CE RED.
An organization having the intent to incorporate Bluetooth wireless technologies into their products must first become a member of the Bluetooth SIG program.
There are several steps required during the application process:
The Qualification process whereby the company has a design that is a specific configuration of hardware and/or software which must be designated under a Bluetooth product type. Product types include (End products, controller subsystems, host subsystem, profile subsystems and components). For more information, it is suggested to reference the Bluetooth Product Listing Database online.
Companies have the option of qualification without additional testing which encompasses technologies already certified by Bluetooth SIG and used within your product without changing or adding additional Bluetooth features.
And secondly, qualification with additional testing which is the creation or modification of Bluetooth technologies or combinations of both already certified and otherwise not certified.
The Declaration process whereby the Bluetooth (SIG) designates a Declaration ID upon receipt of the application, the option of qualification and detailed information from the company including the Design name, model number, design description, hardware version, software Version and so forth.
First and foremost, it is essential that your organization clearly defines and understands the electronic product certification requirements for each country you wish to sell your product. In some cases certain countries may be harmonized, however careful research must be taken into consideration.
Ultimately, having a plan is your best line of defense. As electronic product designers, the compliance process can appear overwhelming and intricate to say the least. Certification labs are a valuable resource that should be considered even during the prototype phase of your design. They typically offer services like Pre-scans which will enable you to gain insights into the electromagnetic characteristics and behaviors that the device exhibits. This initial information is vital in planning your next design revision if it is deemed necessary.
This guide was written in October 2020 by Ryan Clark Watt, a Canadian Electrical, Electronic and Mechanical Engineer with 25 years of experience.
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