This comprehensive guide to electronics and compliance is intended to assist product manufacturers in the electronic industry to better prepare, understand and implement measures in order to ensure the readiness of their products for the marketplace.
An Introduction to the Electronics Industrys
The electronics industry is made up of companies that manufacture, design, assemble and service electronic products. These products consist of various materials, parts, and components that use principles of electricity to perform their major functions. Electronic products may range from more discreet products such as integrated circuits to consumer electronics such as TVs, smartphones, and computers. Electronics may also refer to medical equipment such as heart-rate monitors, or industrial equipment like robots or co-bots. Communication, radio, and networking equipment like routers and switchboards also contain electronic components and fall within the electronics sector.
Safe to say, the electronics industry is everywhere, and it is constantly evolving. Growth in the electronics sector is primarily driven by innovation, with many companies spending significant amounts on research and development to improve their products. With this comes the importance of ensuring the safety and sustainability of electronic products, and ensuring that products meet the correct requirements for entering various international markets.
A Brief History of Electronics
The electronics industry began with the invention of the vacuum diode by J.A. Fleming in 1897. After that, a vacuum triode was implemented by Lee de Forest in order to amplify the electrical signals. This led to the introduction of tetrode and pentode tubes that dominated the world until World War II. After this period, the ‘transistor era’ began with the junction transistor invention in 1948. The subsequent years witnessed the inventions of integrated circuits, which drastically changed the nature of electronic circuits, as the entire electronic circuit was integrated on a single chip, resulting in more efficient performance and cost of electronic devices.
Digital integrated circuits were another significant integrated circuit development that changed the overall architecture of computers. These were developed with transistor-to-transistor logic, integrated injection logic, and emitter-coupled logic technologies. Later, these digital ICs employed PMOS, NMOS, and CMOS fabrication design technologies.
All of the innovations of these components eventually led to the introduction of microprocessors in 1969 by Intel. Soon after, analog integrated circuits were developed, which introduced an operational amplifier for analog signal processing. These analog circuits include analog multipliers, ADC and DAC converters, and analog filters. Essentially, these fundamental components have been continuously innovated since and comprise the key functions of many electronic components and devices still used today.
What Products Fall Under the Electronics Category?
The electronics sector produces everything from industrial electronic equipment, to microelectronics and consumer electronics. While some common examples of electronic products include mobile devices, televisions, and circuit boards; the electronics sector encompasses telecommunications, networking, electronic components, industrial electronics, and consumer electronics.
Growth in The Electronics Sector
Due to increasing demand from emerging market economies, the electronics industry is growing rapidly. In addition, increased consumer spending on such products has resulted in increased demand for electronic products worldwide. With developing economies growing, countries that produce electronics now have strong consumer bases that can afford new electronic products. This also increases competition, which is driving the cost of electronics production down, making products even cheaper for individuals.
China has been a leading producer of electronic products for many decades and is now also a major market for consumer and industrial electronic products. Globally, consumer electronics spending is expected to rise by $36 billion and reach $1.06 trillion by the end of 2021. By 2025, the unified market is forecast to reach a $1.16 trillion value (Statista, 2021).
Electronics and Safety
Due to the nature of electronic products, the electronics industry is heavily regulated, and parts and subcomponents are sold into a broad range of verticals. Businesses wishing to place any electronic products onto the marketplace must ensure that they meet specific requirements pertaining to each component their product possesses. This can sometimes be an arduous process, however, it is imperative to ensure that products meet these requirements to preserve the safety of consumers, businesses, and the sustainability of the product itself. There are always product recalls in the electronics industry, and it is better to be well-prepared than to have a product recalled and be made to start again.
Certification in Europe
CE marking is obligatory for all products that fall under the health and safety directives and regulations established by the European Union. Once CE-certified, products can be sold and distributed freely within the European Union. Electrical appliances fall under the scope of such directives and regulations and must therefore bear the CE mark in order to be sold in the EU.
When it comes to ensuring the safety of electrical equipment, there are multiple routes for compliance. Electronics intended for use in the European Union can be certified according to the Low Voltage Directive and other applicable EU harmonised standards. Alternatively, compliance can be ensured according to the International Electrotechnical Commission (IEC) CB Scheme.
CB Certification for Electrical Equipment
The International Electrotechnical Commission (IEC) is an organisation that outlines global standards for electrical and electronic products. The IEC has established an arrangement for the mutual acceptance of test reports in the field of electrical and electronic equipment: the IECEE Certification Body (CB) Scheme.
Certifying according to the CB Scheme has several benefits:
- Removes trade barriers caused by different certification criteria
- Reduces costs and delays due to various testing and approval processes
- Ensures consumer confidence through an internationally recognised certification
- Holds the potential for one-time testing and certification
The CB Scheme is almost like a ‘product passport’ for the global market. The scheme means that products perform only one set of testing and certification to obtain one or more national certification marks. Each National Certification Body (NCB) will recognise test reports issued by one another so that manufacturers do not need to get a product re-tested if they would like to use a particular certifying body’s test mark on that product.
Should I certify my product according to the CE marking or CB scheme?
After having explored both CE marking & CB Certification for electrical equipment, the question remains: Which is the best approach for certifying electrical equipment?
The CB scheme certification according to IEC 62368-1 provides more flexibility in product design and evaluation without requiring more frequent revisions. Since it acts as a passport for other international certifications, it can be hugely beneficial to certify according to the CB scheme if you are planning to access multiple markets in a short timeframe.
CE marking electronics according to applicable EU harmonised standards could therefore mean a lower cost and shorter timeframe than with the CB scheme (depending on the product). Another benefit is that the manufacturer is responsible for the certification procedure: they can carry out the required conformity assessments without a Notified Body. Compliance with the CB scheme is only possible through the use of test labs and certification bodies.
The downside of CE marking for electrical equipment is that it is only applicable for products sold in the European Union. As increasingly more producers, importers, manufacturers, and designers begin to acknowledge IEC standards as reputable indicators of product safety, applying the CB scheme from the start could lower barriers for international market access in the long run.
Electronics Certification – EU vs. the USA
A manufacturer in the EU can utilize applicable European harmonized standards and/or Directives in order to affix CE marking.
In the United States, however, there is no standardised law that has been put in place when it comes to placing a product on the market. Applicable requirements for a product can come in the form of both mandatory standards and voluntary standards. Just like the EU, products in the US are also categorised as under-regulated and non-regulated products. However, the essential testing, analysis, and procedures after which a product is then placed on the market vary greatly.
Quite often, the Federal Communications Commission (FCC) label or the FCC mark is a certification employed on electronic products in the United States. It certifies that the electromagnetic compatibility and interference from the device are under the limits that the Federal Communications Commission has approved.
FCC objectives are to set applicable standards and testing measures to ensure that Radio Frequency (RF) emissions of electronic devices meet the correct requirements.
On the other hand, there are several voluntary markings that manufacturers may choose to place on their products in the US. An example of this is the UL marking – probably one of the most common – which is a voluntary standard unless the company has been incorporated into federal or state regulations. However, service providers such as Amazon require that many electronic products are compliant with one or more UL standards.
Compliance in the United States of America
US compliance marking is not a legal obligation: the manufacturer can bring products onto the market without USA compliance marking.
Every state in the US has its own liability law according to its own standards, as sanctioned by Congress. The drafting of product safety requirements and compliance inspection is carried out by the same federal agency.
You are required to file a report for dangerous and defective products, but that doesn’t mean they won’t get placed on the market as they are not banned.
Compliance in the European Union
Before it can be placed on the market, CE marking on a product is mandatory to prove that it meets the fundamental legal requirements of the relevant Directive(s).
If the product does not fall under the scope of the CE marking, the General Product Safety Directive 2001/95/EC (GPSD) may apply. The GPSD exists to ensure the safety of non-regulated consumer products before they become available to the masses.
Every new Directive is designed from scratch and is applicable throughout the EU, irrespective of the country. The European Commission drafts the Directives and national authorities to complete the inspection process.
The term ‘CSA certification’ is commonly used in reference to getting a product certified to applicable Canadian national standards, developed by the SCC (Standards Council of Canada) and other standards-making bodies such as CSA (Canadian Standards Association) itself and UL (Underwriters Laboratories). The CSA certification mark in its most common form is a product safety mark for end products and equipment typically used in Canadian workplaces.
Electronics and Regulations
The Low Voltage Directive
The Low Voltage Directive 2014/35/EU (LVD) is considered the ‘overarching’ EU directive for electronics since it is applicable to a wide range of products, including:
- Household appliances
- Power supply units
- Laser equipment
- Electrical components (such as fuses or batteries)
The LVD aims to ensure that electrical equipment within the following voltage limits is safe to use:
- Between 50 and 1000 V for alternating current
- Between 75 and 1500 V for direct current
If your electrical equipment falls under the scope of the LVD, you may only affix the CE mark when your product is in accordance with the requirements outlined in the directive. You must also conduct a risk assessment and document this in your technical file.
All electric devices are subject to electromagnetic interference: they influence each other when interconnected or placed closely beside one another. Think, for example, of the potential static on a phone or television when another appliance is running nearby. The electromagnetic compatibility (EMC) Directive 2014/30/EU exists to control the effects of electromagnetic interference by outlining the techniques and technologies which must be used to reduce such disturbances. All electrical equipment must comply with EMC requirements before being placed on the market. In short, the EMC:
- Limits electromagnetic emissions from equipment
- Governs immunity of equipment
- Seeks to ensure that equipment is not disturbed by radio emissions
When CE marking electronics, producers often have questions about the multiple RoHS directives. RoHS stands for Restriction of Hazardous Substances. The RoHS I restricts the use of ten hazardous materials when manufacturing electronics and electrical equipment.
Restrictions for additional substances have been added since the RoHS I took effect: in 2011, the first amendment was made in the form of the Directive 2011/65/EU (RoHS II). In 2015, the Directive (EU) 2015/863 (RoHS III) added four additional restricted substances to the list, namely:
- Bis(2-ethylhexyl) phthalate (DEHP) (0.1 %)
- Butyl benzyl phthalate (BBP) (0.1 %)
- Dibutyl phthalate (DBP) (0.1 %)
- Diisobutyl phthalate (DIBP) (0.1 %)
If your product falls under the scope of the RoHS, it is important to note that the RoHS II and RoHS III are not replacements, but amendments to the initial directive. You must account for the standards outlined in the original RoHS directive and ensure that your product complies with the additional substance restrictions outlined in RoHS II and RoHS III. The RoHS mark is also widely used voluntarily in other regions of the world as proof of compliant substances.
Radio Equipment Directive (RED)
The Conformité Européenne (CE) mark is required for all electronic products that fall under the Radio Equipment Directive (RED). This directive is applicable for the certification requirements of electronic devices and radio equipment that are manufactured, imported, or sold in the European Union (EU).
The directive ensures that products using radio technology adhere to the required frequency bands with specific power, bandwidth, and duty cycles. It also means that the product makes efficient use of the radio spectrum. As technology has progressed over the years, the number of products operating with radio technology has increased astronomically, and regulations have therefore been enforced to ensure that the proper checks and balances are in place.
In addition to these measures, the directive was recently updated and now also governs technical features for the protection of privacy and personal data, and also against fraud. Furthermore, additional aspects cover interoperability, access to emergency services, and compliance regarding products that combine radio equipment and software (like some artificial intelligence systems, for example).
Electronic Toys: Toy Safety Directive
The safety of toys in the EU is regulated by the Toy Safety Directive 2009/48/EC, which sets the rules on the safety of toys and allows their free movement within the EU borders. It came into force on July 20th, 2011 by replacing the former 20 years old Directive 88/378/EEC.
The Toy Safety Directive contains all essential legal requirements which toys must conform with before they can be placed on the EU market. These safety requirements are divided into two groups: general risks and particular risks. The general criteria mainly relate to the children’s health and safety, while the particular ones are primarily linked to the toy’s properties (e.g. flammability, radioactivity, and electrical, chemical, physical, and mechanical properties).
The Directive applies to products designed or intended for use in play by kids under 14 years of age. Within the scope of the Directive fall products that can be defined as toys except for the following ones:
- Playground equipment designed for public use;
- Automatic playing machines intended for public use;
- Toy steam engines;
- Toy vehicles armed with combustion engines;
- Catapults and slings.
CE marking is a compulsory certification mark for specific goods placed on the EU market. A product bearing the CE marking label is compliant with the minimum product safety, health, and environmental requirements of all relevant EU regulations and directives. The presence of a CE marking label on a product further indicates that appropriate technical documentation and a Declaration of Conformity are available.
Typically, the following product types must bear the CE marking logo:
- Medical devices
- Construction products
- Electrical equipment
- Personal protective equipment
Energy labels are mandatory for all appliances sold in the EU for which a label requirement or regulation exists. They also apply to other products which are likely to directly or indirectly impact energy consumption and other energy-related products. For example, products may include:
- Air conditioners
- Washing machines and dryers
- Domestic ovens
- Lamps and luminaries
The WEEE symbol indicates a separate collection of waste electronics. It is mandatory for most electronics that are imported and sold within the European Union. Product examples include:
- Laptop computers
- Video cameras
- Bluetooth speakers
- LED lights
- Electronic toys
- Laboratory equipment
Electronic Product Compliance in the World of Artificial Intelligence
Introduction to Artificial Intelligence
At its simplest form, artificial intelligence (AI) is a field that combines computer science and robust datasets to enable problem-solving. It also encompasses sub-fields of machine learning and deep learning, which are frequently mentioned in conjunction with artificial intelligence. These disciplines are comprised of AI algorithms that seek to create expert systems that make predictions or classifications based on input data.
As the interest in artificial intelligence accelerates in businesses worldwide, vendors have been scrambling to promote how their products and services use AI. Commonly, people assume that AI only refers to machine learning. However, AI programming focuses on three cognitive skills: learning, reasoning, and self-correction. The learning processes of AI focus on acquiring data and creating rules for how to turn the data into actionable information. These rules are known as ‘algorithms.’
Due to the nature of AI systems, and the rate at which they are being integrated into many products, governments, and regulatory bodies must keep up with implementing regulations and laws to protect the interests of businesses and consumers.
Product Regulations That Apply to Artificial Intelligence
Before placing a high-risk AI system onto the EU market, providers must subject it to a conformity assessment. This will allow businesses to demonstrate that the system complies with mandatory requirements for trustworthy AI systems. In case the system is substantially modified for its intended use, the assessment will have to be repeated.
For certain AI systems, an independent Notified Body will also have to be involved in this process. AI systems will always be deemed high-risk when subject to third-party conformity assessment under that sectoral legislation. For example, with biometric identification systems, a third-party conformity assessment is always required. Providers of high-risk AI systems will also have to implement quality and risk management systems to ensure they are compliant with the new requirements, even after a product is placed on the market. Market surveillance authorities will support post-market monitoring through audits and by offering providers the possibility to report on serious incidents or breaches of which they have become aware.
In addition to this, Member States hold key roles in enforcing the regulation. Each member state should designate one or more national competent authorities to supervise the application and implementation of such protocols and to carry out market surveillance activities. Each Member State should also designate one national supervisory authority to represent the country in the European Artificial Intelligence Board.
Recent Changes to European Legislation in Relation to Artificial Intelligence
On 21 April 2021, the European Commission proposed new rules and actions “aiming to turn Europe into the global hub for trustworthy Artificial Intelligence (European Commission, 2021). The first-ever legal framework around AI was developed, which was essentially designed to ensure the health and safety of consumers buying high-risk AI systems and to future-proof the systems themselves so that they do not pose unacceptable risks that go against important European Union public interests as recognised and protected by law.
AI systems that are identified as ‘high-risk’ should be limited to those that have a significant harmful impact on the health, safety, and fundamental rights of persons in the European Union and such limitation minimises any potential restriction to international trade if any.
In addition to this, the Coordinated Plan on Artificial Intelligence 2021 review was developed to define the global leadership of Europe in adopting the latest technologies, seizing the benefits, and promoting the development of human-centric, sustainable, secure, inclusive, and trustworthy Artificial Intelligence.
The new legal framework, combined with the 2021 Coordinated Plan on Artificial Intelligence is the next step in creating EU global leadership in trustworthy AI. It builds on the strong collaboration between the European Commission and the Member States established during the 2018 Coordinated Plan.
Electronics and the Future
Future Technologies and Business Preparation
While the past couple of years may have seen businesses have to slow down production, with the impact of COVID-19, the coming years are looking better than ever for the world of electronics. McKinsey published an article earlier this year that highlighted these four interrelated trends poised to ‘unwind the old rules of management,’ in other words, speeding up the process of not only production of products, but distribution, transaction, and replacement – thus propagating an atmosphere for amplified consumption of many products worldwide:
All of these trends are contributing to a world that is powered by electronics and artificial intelligence and will lead to increased production of products relating to these industries. It is imperative that businesses continue to think ahead and stay up-to-date with relevant information when it comes to product compliance, regulations, and laws so that they are future-proofed for the era that we are progressively living in.
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