This article presents the international regulations for electrical products and what manufacturers need to do to ensure market access.
Placing an electrical product on an international market represents a very challenging task for any manufacturer. They need to seek and understand the imposed conditions for entering the intended market. These conditions often differ from market to market, from country to country, and even from one state to another state within the same country. For this reason, electrical products manufacturers must know the following information in advance:
- Intended market(s),
- Specific market regulations that apply to the product,
- The ways to obtain market approval and the steps involved in maintaining the received approval.
All of the regulatory documentation should be part of a product’s definition before the schematics and the components design stage of the product are considered. However, manufacturers typically do not obtain all of the above-listed information before starting the product design process and consequently experience compliance issues with placing their products on the market.
A question we have heard over and over again is, “How can my product be compliant for market A but non-compliant for market B?”. Well, different markets have different product safety requirements according to their regulations. Some countries require local certification, while others encourage commerce and display more flexibility. But in both cases, regulatory compliance is mandatory.
For the purpose of this article, we will look into the different international regulations for electrical products. We will also discuss what manufacturers need to do to ensure smooth market access.
CE marking
The CE marking is one of the most useful marks for electrical product manufacturers as it gives access to the EU market. Placing the CE marking on a product implies a self-declaration by the manufacturer that the electrical product fulfils the essential requirements of the relevant EU directives. To fulfil the essential requirements of the relevant directives, the product must comply with several harmonised standards (EN standards). A harmonised standard contains information about technical specifications and performance levels to which products must comply. In cases when an EN standard does not cover essential product performance, manufacturers must perform a specific validation process to prove compliance.
One of the most commonly used EU directives for electrical products is the Low Voltage Directive (LVD) 2014/35/EU. This directive applies to any product designed for use with a voltage rating of between 75 and 1 500 V for direct current and between 50 and 1 000 V for alternating current. Thus, it covers a wide range of products, from wiring material to kitchen appliances to measuring instruments.
Other EU directives that often apply to electrical products are the Electromagnetic Compatibility Directive (EMC), Radio Equipment Directive (RED) and Restriction of Hazardous Substances Directive (RoHS).
Safety testing and certification services for compliance with international regulations for electrical products.
To ensure compliance with the above-stated international regulations for electrical products, manufacturers must carry out a conformity assessment procedure, compile technical documentation (a.k.a. technical file) and draw up a Declaration of Conformity. Often, the technical documentation is incomplete, or the Declaration of Conformity lacks specific details. As a result, product non-compliance occurs, leading to product recalls, monetary fines or even, in some cases, imprisonment. Therefore, it is essential that manufacturers have complete CE compliance documentation. One way to guarantee that is by using product compliance software. Such a tool automates important compliance activities (e.g. identifying relevant EU directives or harmonised standards) and significantly decreases – if not to say eliminates – the risk of human error. Human errors often occur in determining the few applicable standards among more than 20 000 standards.
Lastly, manufacturers must ensure that the CE marking symbol has correct dimensions when affixed on a product. Otherwise, the product will be again considered non-compliant.
NRTLs
In the United States, the regulatory requirements for electrical products are presented in the Code of Federal Regulations. According to the latter, the mandatory federal requirements specify that any electrical product sold in the US shall be “listed” by an NRTL for the purpose for which it will be used. By “listed”, it is meant controlled and monitored by the approval agency or testing facility.
The term ‘NRTL’ was defined in North America and stands for Nationally Recognised Testing Laboratory of the Occupational Safety and Health Administration (OSHA). An NRTL provides manufacturers with a product evaluation, certification/listing, label or acceptance. The laboratory uses the following controls and/or services:
- Evaluation according to applicable standards
- Implementation of control procedures for identifying the certified and labelled product
- Quality inspection of the production line process
- Field inspections to monitor and ensure the proper use of identifying product markings or labels.
The liability regarding the ongoing compliance of a certified/listed product falls entirely within the manufacturer’s or supplier’s responsibility.
Some of the most renowned NRTLs are UL, CSA, TUV, NEMKO and Intertek.
CB Scheme
The Certification Body (CB) Scheme is an international certification system for mutual acceptance of test reports and certificates related to the electrical products’ safety evaluation. Currently, it’s operated under the umbrella of the IEC, which is one of the oldest technical organisations in the world. The IEC is also the leading global organisation for creation and publication of international standards for electrical products. Products that can obtain a CB Scheme approval are, for example, batteries, electric vehicles and appliances, measuring instruments and electrical toys.
Manufacturers of electrical products should consider getting a CB approval as it:
- gives market access to almost half of the world,
- signifies a higher level of assurance regarding a product’s quality,
- may reduce delays and costs involved in multiple testing,
- minimises the risk of product recalls.
Manufacturers who wish to CB certify their products must contact a CB testing laboratory (CBTL) and perform the conformity procedure for obtaining the certificate. The procedure is not complicated, but it could be considerably prolonged due to the specific demands in each country. To carry out the conformity procedure, manufacturers must submit samples to the CB lab for testing to product-specific IEC standards and any national technical differences from IEC standards applicable in the intended markets. Alternatively, manufacturers have the following two options:
Safety testing and certification services for compliance with international regulations for electrical products.
- Submit samples to associated testing laboratories (ACTLs)
- Or perform the testing within their own testing facilities (CTFs).
If one of these two options is chosen, the CBTL will need to conduct product evaluation and testing to assess compliance. If a product fulfils all technical requirements, the CBTL issues a test report and a CB test certificate. The validity of the test certificate is as long as the certified product continues to comply with the initial certification. However, it is important to note that the CB certificate shouldn’t be used in marketing or promotional materials.
ISO registration process
Oftentimes, regulators request that a product’s design and manufacturing be done according to ISO 9000 guidelines. The latter represents a quality management standard family. ISO 9000 applies to businesses from every industry and is used to ensure the realisation of a product that meets customer needs and expectations and fulfils all relevant regulatory requirements. It provides manufacturers with guidelines on establishing and maintaining a quality management system (QMS) within their businesses.
The ISO registration process consists of the following steps:
- Application to a registrar (i.e. an independent ISO accreditation body)
- Review of the submitted documentation by the registrar
- On-site audit of the manufacturing facilities
- If any non-conformities are identified during the audit, the private business must provide adequate responses
- Issuing of the registration certificate by the accredited body
- Continuous surveillance conducted by the registrar at regular intervals (e.g. annual)
When deciding to undertake the ISO registration process, manufacturers must have the following documentation: quality manual, procedures, forms, records and other compliance files.
Lastly, it is important to know that registrars evaluate the way a QMS is implemented but cannot provide guidance on how to implement it.
Product certification marks
Sometimes, the access to a specific market is conditioned on the presence of a particular certification mark on the product. Let’s take as an example the FCC certification mark. This marking is mandatory for all electrical products with radio components sold on the US market. Thus, manufacturers must pass the FCC certification process to market and sell their goods in the US even if their products are already NRTL approved. Product certification marks like FCC are usually easy to see in a product’s label and allow users to track down the product’s certification status.
However, it is important to understand that certification marks are different from trademarks. Trademarks represent a badge of origin, whereas certification marks indicate that products are certified as having specific qualities or characteristics.
Read more about product certifications marks for electrical products.
