What is Hardware Compliance ?

Imagine you buy a new mobile phone and the battery explodes. Or, you plug in a hair dryer and you get shocked, or you work in a factory and a robot arm hits you. Would you want to buy that phone, hair dryer, or want to work in that factory? I assume you would NOT.

Such incidents lead to hefty lawsuits and fines against brands and damage the brand image. For example, if iPhones started exploding, the sales would plunge, which is not good for any business.

Another important piece of this is to keep companies accountable. The incidents like “Bhopal Gas Tragedy of 1984”, “Beirut Explosion of 2020”, or the latest incidents of autonomous vehicles crashing into the general public raises an important questions of “who is responsible” if such accidents occur and human life is at danger.

To prevent these kinds of incidents, keep companies and individuals accountable, hardware compliance is put in place. It is a process to make a product safe. Several organizations, like standard committees that write "compliance rules" aka "standards" like ISO, UL, ANSI, IEC, SAE, regulators like FCC, EU commission, NHTSA, and third party testing labs like UL, Intertek, CSA and TUV, and The manufacturer who builds a product all works together to bring a "safe to use" product to the market. Almost everything that is built goes thru compliance and teting. Next time you use your phone charger, see UL, CE, or ETL marking. Mobile phone, cars, airplanes, batteries, LEDs, headphone, and almost everything you use might have gone thru compliance process. So, now you know what hardware compliance is, let's dive a little deeper into it.

How Compliance Works for a Manufacturer

Let's say you want to build a product and get it certified. You need to follow a few steps as given below.

1. Define Product: A manufacturer can sell one product for different type of buyers/industries like aviation, military, industrial companies, or household use cases. And there could be many types of products like medical equipment, fire protection, safety equipment, equipment for hazardous locations like oil & gas. Based on type of product and market you chose to go, there could be minimal or a lot of additional standards, testing, and costs for access to different markets. Hence it is very important to define the product, specs, use cases, etc and then follow the step 2.

2. Identify Markets: Decide where the product will be sold (US, EU, CA, etc.)

3. Find Applicable Standards Based on the following:

   a. Product type: Is product electrical, battery powered or powered from outlet, automotive, mobile robot, stationary robot, component (Relay, sensor, switch, battery, etc) ?

   b. End user and Environment: Will product be used in factory environment or household, military, hospital, mines, used indoor or outdoor, ambient temperature range, end user trained or the product is for regular user.

   c. Product specifications: Voltage, Current, Power, weight, size, metal or plastic body, internal components, etc.

4. Design as per the Standard: Choose certified components where possible or else design the product as per the standard requirements once all applicable standards have been finalized.

5. Testing & Approval: Some products don’t need certification/testing by a third-party lab (NRTLs) and these. But legislation still allow you to “self-declare” meaning that you as a manufacturer take care of the compliance without a third-party lab. For example, in the USA it is not required to certify various products. Then the question arises, why should I go through all the hassle? Well, even if it is not required, the distributor, seller or end buyer will mostly ask for it. Or, if there is an unfortunate accident leading to a lawsuit, you will be liable. So, either self-declaration or third-party certification is absolutely necessary in today’s world.

6. Documentation: Self explanatory, but documentation with version control is important. In some industries like oil and gas, even changing one small resistor is not acceptable without revision of the product report by third party labs. So, the following should be kept safe.

   • Schematics
   • Analysis & Calculations
   • Test results
   • User manuals and safety instructions, maintenance, etc.

7. Approval: As mentioned earlier one can do self declaration or get certification by 3^rd party labs. If you decide to go with third party labs, they might need to inspect your factory every quarter to assure you are following the practices and meeting the requirements.

   • Self-declare (CE)
   • Submit to lab (UL, TUV, etc.) for certification

Why regions/countries are important? Why not one standard for all regions?

There are few main countries that have their own standard bodies and standards that they follow. For example, USA follows UL, ANSI standards, while EU follows IEC, ISO, and other standards. It would be nice if all requirements would be in one standard. But, standards are hard to make and update. Adding something to a standard which will not help anyone in any way is a futile effort. So, different standards have been written.

Now, some countries have accepted IEC standards since they don’t want to write and maintain their own standards. On the other hand USA and Canada have written their own standards to consider the edge cases applicable to the region. Also, good to note that IEC and ISO are the “base standards” for most of the other standards like UL and ANSI. For example, IEC 61010 is base standard used in EU and other parts of world, while UL/CSA 61010 is mostly a copy of IEC 61010 with some additional requirements. For example, equipment used outdoors should be able to work in extreme low temperatures in Canada. So, UL/CSA 61010 specifically mentions those requirements. Similarly, there are many other edge cases in these regional standards. If you go to NRTL. You will most probably get a different report for USA and Canada and a separate report for IEC(also called CB report) or EN report.

There are other bodies and standards in Indian Standard (IS) in India mostly harmonized with IEC, Guobiao Standards (GB) in China and Japanese Industrial Standard (JIS) in Japan. One must assess the regional standards and requirements as well if you plan to sell in those markets.

Harmonized standard

Did you notice I wrote UL/CSA 61010? Why UL and CSA are written together? This is because the USA and Canada have similar geographies and the edge cases we talked about apply to both countries. So rather than having two different standards, they have been harmonized, i.e. merged, and these are evaluated as one piece.

What are ANSI, UL, ISO, IEC, NEC, NFPA, ROhS, FCC, etc. ?

Role	What They Do	Examples
Standards Bodies	Write the technical rulebooks (standards)	ISO, IEC, IEEE, SAE, RTCA, ANSI
Regulators	Enforce laws and mandate compliance	FAA, FCC, EU Commission, NHTSA
Standard Committees	Experts who draft and revise standards	Working groups under ISO/IEC/SAE
NRTLs (Labs)	Test and certify products to standards	UL, TUV, Intertek, CSA, SGS
Manufacturers	Design, build, and document compliant products	Any company making hardware
Compliance Engineers	Ensure design meets safety and regulatory needs	In-house or external consultants
Notified Bodies (EU only)	Approve high-risk CE-marked products	TÜV SÜD, DEKRA, BSI (for CE)
Accreditation Bodies	Approve test labs and ensure quality	A2LA (US), DAkkS (Germany), UKAS
Suppliers	Provide certified components, material data	Chip makers, enclosure vendors, etc.
Importers/Distributors	Ensure products entering markets are compliant	Often need DoC and labels before selling

Difference between UL, Intertek, TUV, Nemko ?

There are all called NRTL(Nationally Recognized Testing Laboratories). Basically these are testing labs recognized by OSHA who help manufacturers in assessing and testing the product and put a formal marking(stamp) on your product. See the following sample markings.

There is often some confusion about whether manufacturers can get ETL marking if they are using UL standards like UL 12100, UL 121201, etc. Yes this is totally possible. UL(Underwriter Laboratory) and CSA (Canadian Standards Association) are NRTLs but they also write standards. UL standards are prevalent in USA and CSA standards are used in Canada. However, their other branch is NRTL which actually work with manufacturers, test the product and issue compliance reports and markings. Intertek on the other hand do not write standards and you will not see any standard with their name. However, they participate in standard committees of UL, CSA, IEC, etc.

Common product types and the relevant standards.

a. Core Categories of Hardware Compliance

Category	What It Covers	Key Standards & Regions
Electrical Safety	Shocks, fire, insulation	UL 508 (USA), IEC 61010, IEC 62368-1
Functional Safety	Safe behavior even in fault conditions	ISO 13849, IEC 61508, ISO 26262 (automotive)
EMC/EMI	Does it emit/radiate interference?	FCC Part 15, EN 55032, IEC 61326-1
Environmental & Material	Toxic substances, disposal, recycling	RoHS, REACH, WEEE (EU), Prop 65 (US)

b. Industry-Specific Compliance Fields

Field	Focus	Examples
Medical Devices	Patient safety, hygiene, traceability	ISO 13485, IEC 60601, FDA 21 CFR
Hazardous Locations	Preventing explosions in gas/dust areas	ATEX (EU), IECEx (Global), UL 1203, NEC 500
Industrial Automation	Robots, AMRs, safety-rated motion	RIA R15.06, ISO 10218, ISO 3691-4
Consumer Products	Toys, electronics, home devices	ASTM F963, UL 1642 (batteries), CPSC rules
Automotive	Reliability + functional safety	ISO 26262, UNECE R10, FMVSS
Telecom / Radio	RF, Wi-Fi, Bluetooth, SAR	FCC Part 22/24/27, RED (EU), IC (Canada)

c. Automotive Standards

Standard	What It Covers	Example
ISO 26262	Functional safety for road vehicles	Safety of ECUs, sensors, ADAS, etc.
ISO 21434	Automotive cybersecurity	Protects against hacking, tampering
UNECE R10	EMC (electromagnetic compatibility)	Required for UN vehicle approval
ISO 16750	Electrical & environmental conditions	Testing: voltage, vibration, temperature
ASIL (A–D)	Automotive Safety Integrity Levels	Used inside ISO 26262 for safety targets
FMVSS (USA)	US vehicle safety regulations	Enforced by NHTSA, e.g., crash, lighting
SAE J3016	Defines levels of driving automation	L0–L5, used for AV (autonomous vehicles)

d. AI and Software Standards

Standard	What It Covers	Key Use
ISO/IEC 23894 (2023 draft)	AI risk management	System-level AI safety management
ISO/IEC 22989	AI concepts & terminology	Shared language for AI development
ISO/IEC 24029	AI robustness & bias	Evaluation of trustworthiness
ISO/IEC 42001 (coming soon)	AI Management Systems (AIMS)	Like ISO 9001, but for AI governance
IEEE 7000 series	Ethical and safe AI design	AI bias, transparency, and accountability
DO-178C	Software safety in aviation (used in AI flight control)	Certifies airborne software
UL 4600	Safety for autonomous products	Targets AI-driven systems with no human fallback

Summary

Compliance can be overwhelming for engineers new to it. However, giving some time to understand the terms, identifying applicable standards, understanding use case, and reading the standards can make the process easier. Not understanding the process and requirements can lead to extended time and cost to your product launch. There is a lot more to the compliance, and we will cover it in upcoming blog posts. At Saphira, we are trying to help manufacturers get through compliance with our AI tool and help speed up the latest industrial revolution.

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