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IEC

# IEC 62443-4-1

[Source](https://webstore.iec.ch/publication/33615)

Secure product development lifecycle for industrial automation, applied to medical

Last updated · July 25, 2026 

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## What it is

Parent standard underpinning IEC 81001-5-1. Defines the secure development lifecycle for OT and is widely used as evidence of mature SDLC across industries.

## Why it matters

Recognised by the FDA as supporting evidence for the SPDF, and frequently cited by Notified Bodies in the EU.

## Adopted or referenced by

FDA (supporting)  EU Notified Bodies  PMDA (via 81001-5-1) 

## Key clauses

Maturity levels

Practices rated ML1–ML4; ML3+ expected for connected devices.

Threat modelling

Mandatory throughout the lifecycle.

Component requirements

Pairs with 62443-4-2 for technical security requirements.

[Previous IEC 81001-5-1 ](/frameworks/iec-81001-5-1)[Next  ISO 14971 ](/frameworks/iso-14971)

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