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IEC 62304

Status:

PUBLISHED

As of:

IEC‑published in 2006; amendment in 2015; confirmed current in 2021

Region(s):

Global / adopted as national standards (e.g. CEI EN in Europe, FDA-recognized in US)

Body:

International Electrotechnical Commission (IEC), ISO/TC210 (via IEC/SC 62A)

Applicable to:

Medical devices, Healthcare

Summary:

Covers development processes (planning, requirements, design, verification/testing, integration, release, maintenance), classification of software safety, risk‑based use of SOUP, documentation requirements, and QMS integration