A fresh take on product safety, based on hazards, not just rules.
The transition from traditional, prescriptive safety standards to a hazard-based approach is a major change. It represents one of the most significant shifts in the history of regulatory compliance. For decades, engineers relied on a rigid set of instructions that dictated exactly how to build a product to ensure it was safe for the consumer market.
If you design, develop, or certify audio/video, ICT, or communication equipment, you have likely encountered legacy standards. These standards are IEC 60950-1 and IEC 60065. These were the cornerstones of electrical safety compliance for decades. But as technology evolved, a more adaptive approach became necessary.
This evolution birthed IEC 62368-1. A standard that demands a deeper level of engineering intuition and a proactive mindset toward risk. In this deep dive, we will move past the basic definitions and explore how to leverage Hazard-Based Safety Engineering (HBSE) to streamline your certification process and improve product design.
Before we jump into the technical nuances, it is important to understand why the old way of thinking can actually hinder modern innovation. When we follow a prescriptive list, we often stop asking “why” a certain clearance or material is required. This approach can lead to over-engineering. Alternatively, we may miss new risks inherent in high-density electronics.
The following points outline the fundamental pillars of the HBSE process that every safety technician must internalize to move from a “compliance officer” to a “safety partner.”
From “What to Do” to “Why It Matters”
The legacy standards (IEC 60950-1 for ICT and office equipment, and IEC 60065 for AV equipment) were prescriptive in nature. They told manufacturers exactly what distances, insulation types, or fire enclosures to use.
IEC 62368-1 instead asks:
What are the hazardous energy sources in your product? Who or what could be exposed? What safeguards are in place to prevent injury or damage?
This approach is more adaptive. It aligns with modern product development practices and encourages innovation without compromising safety.
The Three Pillars of HBSE
Identification of Energy Sources: Every product is a collection of energy sources, whether electrical, thermal, kinetic, or radiated.
Classification of Potential Effects: We categorize these sources based on their ability to cause pain or injury to a person, or to ignite a fire.
Validation of Safeguards: We implement and test barriers—physical, electrical, or instructional—that sit between the energy source and the body.
The shift toward energy source classification allows for a much more nuanced design phase where safety is baked into the architecture rather than added as an afterthought. By identifying whether a circuit is Class 1, 2, or 3 early in the layout process, a design team can avoid the costly mistake of using expensive reinforced insulation where a simple basic insulation or even no safeguard at all would have sufficed.
Tests like Hipot and Leakage Current are no more a list of requirement to fulfill, but the application level depends on the risks identified by the manufacturer.
Use Case 1: Combining ICT and AV in One Product
Let’s consider a smart speaker with voice assistant features, Bluetooth streaming, and an integrated touchscreen. This type of hybrid product previously straddled two standards:
IEC 60065 for the audio/video functions
IEC 60950-1 for the touchscreen and data interfaces
Challenge under legacy standards: Certifying under both standards introduced complexity, inconsistencies, and redundant testing.
Benefit under IEC 62368-1: The entire product is assessed under one unified framework. This framework is based on its energy sources and user interaction. Whether it’s electrical energy, radiated RF, or thermal hazards, the approach remains the same.
Outcome: Simplified certification. More relevant safety evaluation. Easier global access.
Use Case 2: Innovative Designs and Custom Interfaces
A startup designs a modular communication hub that supports USB-C, Power-over-Ethernet (PoE), and wireless charging. It’s sleek, minimal, and high-performance.
Old approach: The design is constrained by fixed rules. It also faces limitations due to minimum spacing, mechanical enclosures, or fire barriers. These are not easily compatible with modern form factors.
IEC 62368-1 approach: As long as the energy sources are identified and effectively controlled (e.g., limited power circuits, safety ICs, robust thermal design), the form can follow function. The standard allows for engineering judgment, supported by testing and rationale.
Reflection: It’s not about bypassing rules, it’s about meeting safety objectives in smarter, product-specific ways.
One of the most common points of confusion for those new to the regulatory landscape is the jump from “SELV/LPS” terminology to “Class 1, 2, and 3” energy sources. Under the HBSE model, we don’t just look at voltage. We examine the combination of voltage, current, and frequency. This helps us determine the physiological effect on the human body. This is a more scientific approach that respects the fact that a high-voltage, low-current static shock is fundamentally different from a lower-voltage, high-current power supply.
To navigate this successfully, a technician must be comfortable with the “Safeguard Directed” logic. If you have a Class 2 energy source (something that causes pain but not permanent injury), the standard requires at least one “Basic Safeguard.” If you move into Class 3 territory, you must implement “Reinforced” or “Double” safeguards. This logic is consistent across electrical, thermal, and even mechanical hazards like sharp edges or moving parts.
Understanding this table is the “skeleton key” for unlocking the rest of the standard’s requirements. By accurately classifying your energy sources during the prototype phase, you can prevent the “compliance bottleneck” that often happens right before a product launch when a lab discovers an unprotected Class 3 source that requires a total PCB redesign.
Class 1: No injury (e.g., USB port)
Class 2: Could cause pain or minor injury (e.g., exposed 48V terminals)
Class 3: Capable of causing injury (e.g., open mains supply)
Safeguards
Basic, supplementary, or reinforced insulation
Physical barriers
Protective earthing
Software or firmware controls
Energy Class
Effect on Body
Effect on Combustible Materials
Required Safeguard
Class 1
Not painful, no injury
No ignition likely
Usually none required
Class 2
Painful, but no injury
Ignition possible, limited spread
At least one basic safeguard
Class 3
Injury (Burn, Fibrillation)
Ignition and fire spread likely
Reinforced or double safeguards
Pain and Injury Thresholds
IEC 62368-1 quantifies harm thresholds, pain, injury, fire, based on scientific and physiological criteria. This is especially important when software or energy-limiting circuits are involved.
Moving Beyond “The Hipot Mental Trap”
A significant pitfall I see in many quality departments is the tendency to treat 62368-1 testing as a simple “pass/fail” exercise similar to the old Hipot tests. Dielectric strength testing remains a staple of electrical safety. The new standard asks us to consider the conditions under which that insulation might fail. We are now looking at “Abnormal Operating Conditions” and “Single Fault Conditions” with a much more critical eye toward how the product behaves when things go wrong.
For instance, if a cooling fan fails or a ventilation hole is blocked, a hazard-based approach doesn’t just ask if the device catches fire. It asks if the resulting heat changes a previously safe Class 1 surface. Does it become a Class 2 or 3 thermal hazard? This requires a much more robust internal testing protocol that simulates real-world misuse, ensuring that the “Safeguards” we’ve designed are truly effective under duress.
The philosophy here is that safety is a dynamic state, not a static one. As components age or environments change, the relationship between the energy source and the user must remain protected by a reliable barrier. Risk analysis documentation has become just as important as the test report itself. It provides the “why” behind every design choice made by the engineering team.
Transition Challenges and Reflections
Many manufacturers simply “translate” 60950-1 test plans into 62368-1 wording. This undermines the value of the new standard.
Don’t treat 62368-1 like a renamed checklist, treat it like a tool for better, more relevant risk control.
Common pitfalls include:
Using outdated test rationales
Ignoring the hazard identification process
Misinterpreting energy class thresholds
Our recommendation? Train your design and compliance teams together. Align product specs, layout reviews, and safety documentation under the HBSE logic from the start—not retroactively during certification.
IEC 62368-1 represents more than a change in format, it’s a philosophical shift in how we think about product safety. It empowers engineering teams to design better, not just compliant products. By understanding hazards, identifying sources, and applying suitable safeguards, safety becomes an integrated design asset, not a post-design obstacle. This means more freedom of implementation, but also more responsibility in clearly identifying risks.
If you’re working on your next product or planning a certification strategy, make IEC 62368-1 your ally. And remember, compliance done right is an act of care, for your users, your business, and your innovation.
