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IEC / ISO

# IEC 81001-5-1

[Source](https://webstore.iec.ch/en/publication/63293)

Health software & health IT systems safety, effectiveness and security, secure development

Last updated · July 25, 2026 

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## What it is

Process standard derived from IEC 62443-4-1, tailored for health software. Defines a secure development lifecycle (requirements, design, implementation, verification, release, post-release).

## Why it matters

Cited or adopted by the EU (via MDCG 2019-16), Japan (JIS), UK (BS EN), Singapore and TGA. Complying with it satisfies most jurisdictions' SDLC expectations.

## Adopted or referenced by

EU MDR  Swissmedic  MHRA  PMDA (JIS T)  TGA  HSA 

## Key clauses

Activities mapped to IEC 62304

Aligns directly with the medical software lifecycle standard.

SBOM

Requires identification and management of third-party components.

Vulnerability handling

Defines coordinated disclosure and patching expectations.

[Previous IMDRF N70 ](/frameworks/imdrf-n70)[Next  IEC 62443-4-1 ](/frameworks/iec-62443-4-1)

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