Introduction
Timing certification for your product is critical. Certifying too early could mean retesting if you make design changes later. However, early testing can reveal design flaws that must meet certification standards. Balancing this process is key to minimizing delays and ensuring your product is market-ready.

It’s crucial to integrate certification requirements into the development stage to avoid costly, time-consuming design overhauls later. For example, plan for regulatory standards like RoHS from the outset by selecting lead-free components during the design phase.

Certification testing is not only expensive but also time-intensive—it can take anywhere from a month for streamlined designs to a year if facility queues or unforeseen challenges arise. To minimize the number of testing rounds, ensure your design is as complete as possible before submitting a production-ready unit for certification. Keep in mind that certification delays will impact your ability to ship products to customers.

Additionally, many certification bodies require finalized documents, such as your instruction manual, to accompany the units being tested. Be sure to have all such materials ready before beginning the process.

Regardless of your product type or target markets, working with Sigma Design & Consulting, can be invaluable in navigating the complexities of certifications. Even highly skilled design engineers may not have the specialized knowledge needed for smooth certification compliance.

For startups, it’s particularly important to understand that global marketing involves significant regulatory testing costs for each country. A focused approach—targeting a single country or region first—will help manage costs and streamline the process.

For instance:

• North America: The U.S. and Canada share overlapping certification requirements, allowing most products to be sold in both markets with a single certification effort.

• Europe: The EU has harmonized standards, making it easier to sell in multiple countries under a single certification (e.g., CE, ATEX).

• Asia: Regulations vary significantly by country, making market entry more complex and often requiring local expertise. Consider Asia only once your company has sufficient resources and on-ground presence.

Though you shouldn’t begin certification testing until you have a production-quality unit, understanding the certification landscape during development will help avoid surprises.

Understanding Certifications for Instrumentation and Electronic Hardware
For electronic products and instrumentation, multiple certifications are often required to meet market and service requirements. The exact certifications depend on your product’s specifics and the countries you plan to sell in.

Don’t underestimate the time and financial investment required to achieve these certifications. While it might not be the most exciting aspect of product development, understanding the certifications your product needs is vital for success.

Key certification schemes include:

• United States (UL)

• Canada (CSA)

• European Union (CE, ATEX)

• Worldwide (IEC, IECEx)

Although these certifications often have overlapping requirements, additional regional certifications may apply. Thorough research or consulting with experts is critical to ensure your product complies with all applicable regulations.

By strategically planning and aligning your design process with certification needs, you can minimize risks and position your product for a successful launch in your chosen markets.Description text goes here

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 has superseded UL60950 in North America in 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 a power supply that has 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.

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 it is highly suggested you consult with us on UL certification process to review the design before you proceed too far with development.Description text goes here

Understanding RoHS Certification

RoHS certification confirms that a product is free from harmful substances like lead, cadmium, and mercury. Compliance with RoHS standards is mandatory for products sold within the European Union and California.

Because many products are distributed in these regions, RoHS has become the unofficial standard for environmental compliance across the industry. Fortunately, RoHS certification is relatively straightforward and cost-effective to obtain. In some cases, your contract manufacturer may even handle this process on your behalf.

It’s essential, however, to verify that your manufacturer adheres to the latest amendments of the RoHS 2 standard. Remember that RoHS regulations cover all components of your product, including the enclosure and screws.

Additionally, mixing leaded and lead-free components on a single PCB assembly is not recommended, as the reflow profiles for each type are incompatible. For this reason, it’s wise to use lead-free components from the very start of your project. Most components are available in both leaded and lead-free versions, but opting for leaded parts during prototyping can create challenges later. Transitioning to lead-free components at the manufacturing stage often requires reworking the Bill of Materials (BOM), which is time-consuming and can delay production.

What is RoHS Compliance?

The Restriction of Hazardous Substances (RoHS) is a regulation targeting the reduction of hazardous materials in electronics and electrical devices. Initially introduced in the European Union in 2002 under Directive 2002/95/EC, RoHS restricts six hazardous materials. Since July 1, 2006, products sold in the EU must comply with RoHS standards.

The regulation was updated in 2011 with Directive 2011/65/EU, known as RoHS 2. This revision introduced stricter documentation requirements, added product categories 8 and 9, and made RoHS compliance a requirement for CE marking. Later, in 2015, Directive 2015/863 (RoHS 3) expanded the list of restricted substances by including four phthalates.

Are You Ready for RoHS Compliance in 2025?

If your business manufactures, distributes, or sells electronic or electrical devices, components, sub-assemblies, or spare parts in markets governed by RoHS, compliance is mandatory. The regulation also applies if your company supplies resellers or integrators serving these markets.

With the ongoing digital revolution, the production of electronic devices continues to rise, encompassing products like smartphones, IoT devices, smart home assistants, drones, medical equipment, and 3D printers—all of which fall under RoHS regulations.

Restricted Substances Under RoHS

RoHS regulations set maximum concentration levels for 10 hazardous substances in products. The original six were established under the first RoHS directive, while RoHS 3 (effective July 22, 2019) added four more substances. The restricted substances and their limits are as follows:

1. Cadmium (Cd): < 100 ppm

2. Lead (Pb): < 1000 ppm

3. Mercury (Hg): < 1000 ppm

4. Hexavalent Chromium (Cr VI): < 1000 ppm

5. Polybrominated Biphenyls (PBB): < 1000 ppm

6. Polybrominated Diphenyl Ethers (PBDE): < 1000 ppm

7. Bis(2-Ethylhexyl) Phthalate (DEHP): < 1000 ppm

8. Benzyl Butyl Phthalate (BBP): < 1000 ppm

9. Dibutyl Phthalate (DBP): < 1000 ppm

10. Diisobutyl Phthalate (DIBP): < 1000 ppm

RoHS and WEEE Compliance

The Waste from Electrical and Electronic Equipment (WEEE) directive is closely linked to RoHS. WEEE Directive 2002/96/EC focuses on the proper recycling, recovery, and disposal of electronic waste, which often ends up in landfills. Products sold in the EU must meet WEEE compliance standards and display the "Wheelie Bin" label to signify proper disposal.

CE (Conformité Européenne) Marking

The CE marking is a crucial requirement for many products sold within the European market. "CE" stands for Conformité Européenne, which translates to European Conformity. Initially known as the EC Mark, the certification was officially renamed the CE Marking in 1993.

The presence of the CE marking on a product indicates that the manufacturer has declared that the product meets the health, safety, and environmental standards set by the European Union. This is similar to certifications like UL and FCC in the United States.

When is CE Marking Required?

CE marking is mandatory only for products that fall under specific EU regulations that require it. Some products may need to comply with multiple EU directives simultaneously. It is essential to ensure your product meets all relevant regulations before affixing the CE marking. It is illegal to place the CE marking on products that do not require it or that do not meet the required EU specifications.

EU Declaration of Conformity (DoC)

The EU Declaration of Conformity (DoC) is a formal document that must be signed by the manufacturer (or their authorized representative) to confirm that their products meet all relevant EU requirements. By signing this document, you assume full responsibility for ensuring your product complies with EU regulations.

How to Prepare a Declaration of Conformity

As a manufacturer, you are responsible for creating the EU Declaration of Conformity. This document should include the following details:

• Your name and full business address, or that of your authorized representative.

• The product's serial number, model, or type identification.

• A statement confirming your responsibility for the product's compliance.

• Identification details for traceability, such as images or part numbers.

• Information about the notified body (if applicable) that performed the conformity assessment.

• Relevant EU legislation that the product complies with, including any harmonized standards or other methods used to demonstrate compliance.

• Your name and signature.

• The date the declaration was issued.

• Any supplementary information (if applicable).

For imported products, the importer must ensure that the product comes with a DoC and retain a copy for 10 years after it has been placed on the market.

Additionally, the EU Declaration of Conformity must be translated into the language(s) of the EU country where the product is being sold.

CSA (Canadian Standards Association) is an alternative to UL certification and is valid in both Canada and the United States.

A CSA Certification, issued by the Canadian Standards Association, is a widely recognized indicator of safety and quality in North America. Products displaying the CSA-approved mark are tested and verified to meet stringent safety standards, ensuring reliability and compliance. Below, we explore the key aspects of CSA certification, including its benefits, requirements, and how it compares to UL certification.

Why Choose CSA Certification?

1. Market Expansion
   CSA certification opens access to markets in Canada, the U.S., and internationally, providing manufacturers with a competitive edge.

2. Safety and Risk Reduction
   By adhering to CSA standards, manufacturers can significantly reduce risks associated with product recalls, legal challenges, and liability claims.

3. Enhanced Customer Confidence
   Products bearing the CSA mark are perceived as more reliable, helping to build consumer trust.

Products Requiring CSA Certification

CSA certification is crucial for safety-critical products across various industries. These include:

• Electrical Components: Wiring, circuit breakers, and panels.

• Gas Appliances: Stoves, water heaters, and similar equipment.

• Industrial Machinery: Tools and equipment used in manufacturing.

• Medical Devices: Equipment ensuring patient safety.

• PLC’s, HMI

• Sensor and instrumentation

The CSA Certification Process

The journey to CSA certification involves several steps:

1. Product Testing
   Products undergo rigorous testing to meet CSA’s safety and performance benchmarks.

2. Documentation Review
   Manufacturers submit detailed design specifications, test reports, and manufacturing processes for evaluation.

3. Factory Inspections
   CSA auditors may visit production facilities to ensure adherence to certification requirements.

4. Continuous Compliance
   CSA certification requires ongoing monitoring to maintain product safety and quality over time.

CSA vs. UL Certification

While CSA originates in Canada and UL in the U.S., both are widely accepted in North America. Key differences include:

• Scope: CSA often serves both Canadian and U.S. markets, while UL is more U.S.-centric.

• Recognition: Both marks are equally respected and often interchangeable for cross-border applications.

• Cost and Process: Manufacturers should consider their specific market needs and budgets when selecting a certification body.

Conclusion

CSA certification is a hallmark of quality and safety, ensuring that products meet stringent standards while enhancing marketability and customer trust. By understanding the process and benefits of CSA certification, manufacturers can make informed decisions to ensure compliance and build a strong reputation in their respective markets.

Contact us to explore more about CSA certification and how it can elevate your products to new standards of excellence.

ATEX Certification: Ensuring Safety in Hazardous Environments

Key Highlights:

1. Essential for Safety: ATEX certification is indispensable for mitigating explosion risks in hazardous atmospheres and workspaces.

2. Comprehensive Coverage: It spans from individual equipment to workplace environments, requiring strict adherence to safety protocols.

3. Stringent Process: The certification process involves meticulous evaluation to ensure compliance with the highest safety standards.

Introduction to ATEX Certification

In hazardous environments, where ignition sources pose significant risks, ATEX certification emerges as a critical safety standard. But what does ATEX entail?

Derived from the French term Atmosphères Explosibles, ATEX certification ensures that equipment and protective systems used in explosive atmospheres comply with European Union (EU) safety directives. This comprehensive certification process assesses equipment design and functionality to confirm it can operate safely without triggering explosions.

Whether used on oil rigs, pharmaceutical plants, or gas pipelines, ATEX-certified equipment provides operators and inspectors with the confidence that robust safety measures are in place.

The ATEX Certification Process

The journey to ATEX certification involves several steps to ensure compliance with essential safety standards. Below is a breakdown:

Step 1: Hazardous Area Classification

• Similar to the NFPA 70E (NEC) Identify and classify the hazardous areas where equipment will operate.

• Evaluate the presence and frequency of flammable gases, vapors, mists, or dust.

Step 2: Equipment Group and Category Determination

• Categorize equipment based on its intended use:

  • Group I: Mining applications.

  • Group II: Other hazardous environments.

• Assign categories to denote required protection levels for specific zones.

Step 3: EU-Type Examination

• Equipment requiring high protection levels undergoes rigorous evaluation by a notified body.

• This includes ignition risk assessments, design reviews, and testing.

Step 4: Quality Assurance

• Manufacturers implement quality assurance systems to maintain production consistency. Typically ISO 9000

• Certification bodies audit these processes to ensure ongoing compliance.

Step 5: Technical Documentation

• Compile a detailed technical file covering design, manufacturing, and operational aspects.

• Maintain this documentation for regulatory review when needed.

Step 6: Declaration of Conformity

• Manufacturers declare compliance with ATEX directives and affix the CE mark to certified equipment.

Step 7: Ongoing Compliance

• Regular audits, maintenance, and updates ensure the equipment continues to meet ATEX standards throughout its lifecycle.

ATEX vs. IECEx: Key Differences

While both ATEX and IECEx certifications ensure safety in explosive environments, they differ in scope and process:

Aspect

ATEX

IECEx

Geography

Mandatory in EU countries.

Recognized globally, facilitating trade.

Process

Self-certification for lower risks; third-party testing for higher risks.

All certifications are conducted by IECEx-approved bodies.

Documentation

CE marking and EU Declaration of Conformity.

IECEx Certificate of Conformity.

ATEX Zones: Hazard Classification

ATEX categorizes hazardous areas into zones based on the frequency of explosive atmospheres:

For Gas Environments

• Zone 0: Continuous or prolonged explosive atmosphere presence.

• Zone 1: Occasional explosive atmosphere during normal operations.

• Zone 2: Explosive atmosphere unlikely under normal conditions but possible briefly.

For Dust Environments

• Zone 20: Continuous or frequent combustible dust presence.

• Zone 21: Occasional combustible dust in normal operation.

• Zone 22: Rare and short-duration dust presence.

Benefits of ATEX Certification

1. Enhanced Safety: Protects personnel and assets from explosion risks.

2. Regulatory Compliance: Ensures adherence to EU safety directives, reducing legal liabilities.

3. Market Access: Allows products to be sold and operated within the EU.

4. Operational Integrity: Demonstrates commitment to safety, reliability, and quality.

Conclusion

ATEX certification represents more than regulatory compliance—it’s a dedication to safeguarding lives and assets in hazardous environments. By choosing ATEX-certified equipment, industries uphold the highest safety standards, ensuring operations are efficient and secure.

Whether you’re navigating compliance challenges or seeking ATEX-certified solutions, Sigma Design & Consulting can provide expert guidance. Trust our commitment to help you certify your equipment for excellence in hazardous conditions.