IS/IEC 62368-1:2023 Component Compliance: How Clause 4 Works

Clause 4 of IS/IEC 62368-1:2023 — Components and Materials — is one of the most technically complex and frequently misunderstood aspects of the new standard. This guide explains how Clause 4 works and what it means for your products.

What Clause 4 Covers

Clause 4 specifies how individual components used in your product must be evaluated for compliance. It covers:

• Acceptable component certifications and how they translate under IS/IEC 62368-1:2023
• When components need independent testing vs. can be accepted based on manufacturer data
• Materials requirements (flammability, tracking resistance)
• Printed circuit board flammability classification

The Legacy Component Problem

Many products use components that were originally certified under IEC 60950-1 (the predecessor to IS 13252) or IEC 60065 (the predecessor to IS 616). IS/IEC 62368-1:2023 Clause 4 specifies exactly how these legacy certifications are accepted — and in some cases, they are not directly transferable without re-evaluation.

Key Component Categories Under Clause 4

• Transformers: Insulation system classification must map to IS/IEC 62368-1 requirements
• Capacitors (Y-capacitors across mains): Must be certified to IEC 60384-14 or equivalent
• Fuses: Must meet appropriate fuse standards with correct breaking capacity
• Switches and relays in safety-critical circuits: Must meet applicable switch standards
• MOVs (Metal Oxide Varistors) for transient suppression: Must be certified for the application
• Printed circuit boards: Flammability classification (V-0, V-1, V-2, HB) must meet the requirements of the enclosure they're in

Practical Audit Process

When preparing for IS/IEC 62368-1:2023 testing, conduct a Clause 4 component audit:

1. List all safety-critical components in your product
2. Gather current certification documents for each component
3. Ask your BIS-recognized lab to review the component certifications against Clause 4 requirements
4. Identify any components that need re-evaluation or replacement

Discovering Clause 4 issues during formal testing — after samples have been shipped and lab time booked — is costly. A pre-compliance Clause 4 audit before formal testing is highly recommended. HOT offers pre-compliance component audits.