IEC 62368-1 Compliance: A Strategic Guide to Global Hardware Certification

Understanding IEC 62368-1 Compliance Requirements

IEC 62368-1 became mandatory for all Information Technology Equipment (ITE) and Audio/Visual (AV) products as of December 20, 2020, replacing legacy standards IEC 60950-1 and IEC 60065.

More than a regulatory update, it represents a fundamental redesign of safety thinking – shifting from incident-based requirements to Hazard-Based Safety Engineering (HBSE), a model that prevents harm by controlling energy sources.

This shift changes how manufacturers design, test, and certify products.

Instead of following rigid, prescriptive rules, IEC 62368-1 requires companies to identify potential hazards early in the design process and apply safeguards proportional to risk. The approach encourages flexible, innovation-driven compliance, supporting safety without restricting technology development.

For manufacturers, true compliance means building safety into the product lifecycle, not treating certification as a final step. When integrated strategically, IEC 62368-1 becomes a framework for safer design, faster certification, and broader global market access – not just a regulatory checkbox.

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‍Key Points

• IEC 62368-1 became mandatory for information technology (IT) and AV products in North America and the European Union (EU) by December 2020, replacing legacy standards with a proactive HBSE approach that focuses on identifying energy sources and implementing safeguards rather than prescriptive design requirements.
• The standard uses a systematic energy classification system with six types of hazardous energy (electrical, fire, chemical, mechanical, burn, radiation) across three risk classes, enabling manufacturers to tailor safety measures based on energy magnitude and user expertise levels.
• For products certified under IEC 62368-1, the Certification Body (CB) Scheme remains the most efficient framework for global certification across 50+ countries, though its acceptance varies by issuing body and region—making strategic laboratory selection and advisor guidance critical for cost-effective compliance.
• The 4th edition of IEC 62368-1 (published 2023) eliminates legacy component acceptance, requiring all components to have full IEC 62368-1 certification, creating supply chain challenges and requiring strategic transition planning for manufacturers.
• Typical certification takes 4-6 weeks and costs vary significantly based on pathway selection—CB Scheme provides maximum global reach while direct national certification may be more cost-effective for single-market strategies.

IEC 62368-1 Standard Overview and Scope

IEC 62368-1 is an international safety standard for AV, IT, and communication equipment.

It was developed by the International Electrotechnical Commission (IEC) Technical Committee 108 (TC108) to unify decades of fragmented safety requirements under a single, forward-compatible framework.

The standard applies to electrical and electronic equipment with rated voltages up to 600V, including computers, smartphones, tablets, televisions, gaming consoles, network infrastructure, and emerging Internet of Things (IoT) devices. It also covers associated components, power supplies, and accessories used within those systems.

By integrating what were previously two separate standards – IEC 60950-1 (IT equipment) and IEC 60065 (AV equipment) – IEC 62368-1 eliminates overlapping requirements and introduces a technology-neutral approach adaptable to future innovations.

This broad coverage reflects the convergence of modern devices that blend computing, communication, and media functions, requiring a unified view of product safety.

For manufacturers, this consolidation simplifies compliance across product categories while encouraging consistency in design and certification practices worldwide.

IEC 62368-1 Impact & Adoption

After its publication, the adoption of IEC 62368-1 progressed at different rates across global regions. North America moved forward quickly, while Europe delayed implementation to address issues identified in the first edition.

The December 20, 2020 withdrawal date marked the formal replacement of legacy standards in most major markets, though several countries continue aligning their national versions of the standard.

The transition required significant adaptation across the compliance ecosystem.

Testing laboratories retrained personnel to apply hazard-based safety methodologies, and supply chains adjusted to new component-level certification requirements. Transitional provisions permitted temporary use of legacy-certified parts under specific conditions, allowing manufacturers time to update their documentation and sourcing strategies.

Overall, global adoption of IEC 62368-1 has modernized the approach to product safety certification, aligning international markets around a unified, risk-based framework and reducing long-term testing redundancies for multinational manufacturers.

IEC 62368-1 New Approach

The hazard-based safety standard approach fundamentally transforms how manufacturers design safe products. Unlike legacy incident-based standards that prescribed specific solutions to known problems, HBSE requires manufacturers to identify potential energy sources and implement appropriate safeguards proactively and design protections that are proportional to those risks.

At its core, the standard classifies energy sources by type and magnitude. Common types include electrical, thermal, chemical, mechanical, and radiation energy.

Each source is then assigned to one of three energy classes based on its capacity to cause harm:

• Class 1: Minimal risk, generally safe under normal conditions
• Class 2: Can cause pain or startle; requires basic safeguards
• Class 3: Capable of injury; demands robust protection measures

IEC 62368-1 also distinguishes between user categories, recognizing that different users have varying levels of expertise and exposure:

• Ordinary persons: General consumers without technical training
• Instructed persons: Individuals trained to recognize and avoid specific risks
• Skilled persons: Technicians or professionals qualified to work safely with hazardous energy

This dual classification system – by energy level and user type – creates a flexible, technology-neutral framework. Because the standard is based on energy sources within products, it adapts easily to new materials, designs, and emerging technologies without requiring major revisions.

Navigating IEC 62368-1 Requirements Across Global Markets

IEC 62368-1 integrates into a network of regional safety and regulatory frameworks that differ by market.

In Europe, it supports Conformité Européenne (CE) marking under the Low Voltage Directive (LVD) for electrical safety, while in the United States, it typically complements Federal Communications Commission (FCC) Part 15 requirements, which govern electromagnetic emissions.

Knowing these regional interconnections helps manufacturers plan certification strategies that satisfy multiple authorities simultaneously.

The Certification Body (CB) Scheme offers the most efficient route for international compliance. With participation from more than 50 countries, including major markets such as Germany, France, China, Japan, South Korea, the United States, and Canada, the CB Scheme enables a single testing and certification process to be recognized across multiple jurisdictions.

When pursuing certification through a CB testing laboratory, manufacturers should verify:

• Active CB Scheme membership status
• Scope of recognition for IEC 62368-1 testing
• Established relationships with National Certification Bodies (NCBs) in target markets
• Experience managing CB certificate applications and understanding national differences

Selecting the right laboratory under the CB Scheme can significantly reduce redundant testing and streamline market access by producing a single, widely accepted test certificate.

A Few Caveats about CB Scheme

While the CB Scheme offers broad market access, its acceptance and value vary among regions and certification bodies.

Some NCBs fully recognize CB reports, while others treat them only as reference documents requiring supplemental testing. Manufacturers should therefore confirm local acceptance policies early in the compliance planning process.

The following common caveats illustrate where recognition can vary most:

• Inconsistent national acceptance: Some markets require supplementary local testing even with a CB report.

• Product-category limitations: Certain laboratories are authorized only for specific device types or voltage ranges.

• Operational inconsistencies: Approval speed and documentation requirements can vary by laboratory and market, sometimes delaying recognition.

While the complexity of these regional and procedural differences might tempt manufacturers to rely solely on national certifications, doing so can limit future expansion flexibility.

By understanding these variations, manufacturers can choose the most efficient certification path – whether through the CB Scheme or direct national approvals – while maintaining long-term compliance readiness.

Transition to IEC 62368-1 4th Edition

The 4th edition of IEC 62368-1 was published on May 26, 2023, with regional adoptions following shortly after: EN IEC 62368-1:2024 in Europe (April 2024) and CSA/UL 62368-1:2025 in North America (July 2025). The most significant change removes Clause 4.1.1, which had previously allowed the continued use of legacy components certified under IEC 60950-1 and IEC 60065. From the 4th edition onward, all components must have full IEC 62368-1 certification.

This shift creates immediate challenges for component suppliers and Original Equipment Manufacturers (OEMs).

Parts previously accepted under older standards will now require recertification before inclusion in 4th-edition products. Manufacturers must decide whether to pursue early certification or delay until adoption deadlines – early movers can gain an advantage by supporting customers through the transition.

To manage the transition effectively, companies should address several key areas:

• Legacy inventory: Evaluate remaining component stocks and develop a replacement plan for items lacking 4th-edition certification.

• Regional timelines: Monitor market-specific adoption dates; some regions may allow earlier editions longer, enabling phased transitions.

• Supplier coordination: Communicate certification expectations early to ensure component alignment and prevent production delays.

• Testing strategy: Consolidate recertification efforts to minimize redundant testing and documentation updates.

Because legacy component acceptance is ending, supply-chain coordination becomes critical. OEMs and component vendors should collaborate closely to align certification levels, reduce last-minute testing burdens, and ensure continuous compliance across all target markets.

What To Expect in IEC 62368-1 Testing

In practice, IEC 62368-1 testing and certification evaluate a product’s overall safety design and supporting documentation.

Testing typically includes:

• Power supply evaluation – verifying protection against electrical hazards
• Component assessment – confirming that safety-critical parts meet certification requirements
• Construction analysis – reviewing internal design, spacing, and insulation
• Marking and labeling verification – ensuring compliance with identification and safety labeling rules

Manufacturers must also provide a complete set of technical documentation to support testing, including:

• Circuit descriptions
• Component specifications
• Safety-critical parts lists

Typical testing timelines range from four to six weeks for standard products.

More complex designs may require additional testing iterations, especially when new component certifications or construction changes are introduced.

Careful pre-submission preparation – such as verifying component documentation and labeling accuracy – can shorten turnaround times and prevent retesting delays.

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Conclusion

IEC 62368-1 compliance is more than a regulatory requirement — it’s a framework for safer, more innovative, and globally competitive products.

True success depends on understanding regional variations, selecting the right certification pathways, and planning proactively for evolving editions of the standard. Beyond achieving certification, the process strengthens a company’s design discipline and quality culture across global operations.

By integrating compliance strategy early in product development, manufacturers turn regulatory readiness into a lasting market advantage.

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