📘 LEVEL 1 — GLOBAL COMPLIANCE FOUNDATIONS

Goal:
Understand why compliance exists, global structure, regulatory bodies, and risk classification.

Covers:

• What is compliance?
• Hazard-based vs prescriptive standards
• Self-declaration vs mandatory approval
• Certification vs testing vs marking
• CB scheme
• Risk categories

1️⃣ What is Product Compliance?

Product compliance ensures that an electronic product:

• Is electrically safe
• Does not emit harmful interference
• Survives environmental stress
• Uses restricted materials properly
• Meets region-specific legal requirements
• Meets domain-specific risk requirements

Compliance = Technical conformity + Legal acceptance + Market access

2️⃣ Global Compliance Structure (High-Level Model)

Every electronics product falls into these core pillars:

Pillar	Covers
Electrical Safety	Shock, fire, thermal risk
EMC / EMI	Emissions & immunity
Environmental	Temperature, vibration, humidity
Functional Safety	System-level risk mitigation
Material Compliance	RoHS, REACH
Energy Efficiency	Power limits
Domain-Specific	Medical, automotive, etc.

3️⃣ Global Regulatory Ecosystem

International Standards Bodies

• International Electrotechnical Commission (IEC)
• International Organization for Standardization (ISO)
• International Telecommunication Union (ITU)

These create standards.
Countries adopt or modify them.

4️⃣ Major Regional Regulatory Authorities

Region	Authority	Mark
Europe	European Commission	CE
USA	Federal Communications Commission	FCC
USA	Underwriters Laboratories	UL
China	China Compulsory Certification	CCC
India	Bureau of Indian Standards	BIS
Japan	METI	PSE
Korea	KATS	KC
Australia	ERAC	RCM

5️⃣ Domain Overview — Standards Listing (High-Level)

Now we list standards domain-wise (no deep explanation yet).

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🏠 A) Consumer Electronics

Electrical Safety

• IEC 62368-1
• IEC 60335 (Household appliances)

EMC

• CISPR 32
• CISPR 35
• IEC 61000-4-x series

Environmental

• IEC 60068 series

Material

• RoHS
• REACH
• WEEE

🚗 B) Automotive Electronics

Electrical & Environmental

• ISO 16750
• ISO 7637 (transients)

EMC

• CISPR 25
• ISO 11452

Functional Safety

• ISO 26262

Component Qualification

• AEC-Q100 / Q200

🏭 C) Industrial Equipment

Safety

• IEC 61010-1
• IEC 60204 (Machinery electrical safety)

EMC

• IEC 61000-6-2 (Industrial immunity)
• IEC 61000-6-4 (Industrial emission)

Environmental

• IEC 60068
• IP ratings (IEC 60529)

🏥 D) Medical Devices

Electrical Safety

• IEC 60601-1

EMC

• IEC 60601-1-2

Risk Management

• ISO 14971

QMS

• ISO 13485

✈️ E) Aerospace

Environmental

• RTCA DO-160

EMC

• DO-160 Section 20

Quality

• AS9100

🛡 F) Defence

EMC

• MIL-STD-461

Environmental

• MIL-STD-810

Quality

• MIL-STD-883 (microelectronics)

🚢 G) Marine / Naval

Safety & Environmental

• IEC 60945

Classification Bodies

• DNV rules
• Lloyd’s Register

6️⃣ Certification Types (Cross-Domain)

Type	Meaning
Self-Declaration	Manufacturer declares compliance
Third-Party Certification	Accredited lab approval
Type Approval	Government certification
CB Scheme	International safety report sharing

7️⃣ Hazard-Based vs Prescriptive Standards

Modern standards (IEC 62368) → Hazard-based
Older standards → Construction-based

This is important for future deep learning.

8️⃣ Compliance Lifecycle

1. Product concept
2. Risk assessment
3. Design for compliance
4. Pre-compliance testing
5. Accredited lab testing
6. Certification
7. Factory audit (if required)
8. Market surveillance

🎯 Outcome of Level 1

After Level 1, an engineer should:

• Understand all major domains
• Recognize key standards per domain
• Know which pillar applies to which product
• Understand regulatory vs voluntary marks