This course covers Edition 1 — IEC 62304:2006 with Amendment 1:2015, the version currently in force. The changes listed below are proposed for Edition 2 and are not yet confirmed.
Expanded scope: The standard is proposed to cover health software broadly, not just medical device software. This aligns with IEC 82304-1, which applies at product/validation level — a standard more widely applicable than many practitioners realise.
Simplified classification: The three safety classes (A, B, C) are proposed to be replaced by two Software Process Rigor Levels — Level I (software that cannot contribute to a hazardous situation) and Level II (all other software).
QMS and risk management references softened: Explicit normative references to ISO 13485 and ISO 14971 are proposed to become general requirements to follow the applicable product-level standard, with ISO 13485 / ISO 14971 referenced in notes only.
Legacy software: The legacy software provisions are proposed to move from normative requirements to an informative annex.
Source: IEC TC 62 work programme and Edition 2 committee drafts.
Reviewed .
Edition 2 is still in development, so confirm the current stage with IEC
before relying on this. Where our content comes from.
Software Lifecycle Process Areas
IEC 62304 ED1 organises software development into defined process areas across Clauses 4–9. Click any card to expand its requirements. Use Level to switch between an overview and detailed clause-referenced content, and filter by safety class to focus on what applies to your software.