IEC 61508 ↔ IEC 62304 crosswalk
8 listed tools carry cited mappings to both IEC 61508 and IEC 62304: 21 cited cells across 3 + 2 requirement areas.
The two frameworks
IEC 61508
- Scope. Aspects to be considered when E/E/PE systems are used to carry out safety functions. Basic safety publication according to IEC Guide 104. IEC catalog
- Status. International Standard. Facilitates the development of product and application sector international standards. IEC catalog
- Certification. Does not by itself confer an AI-specific SIL. Official catalog pages we cite do not say ISO/IEC TR 5469 replaces it. IEC catalog
IEC 62304
- Scope. Life-cycle requirements for medical device software when the software is itself a medical device or is an embedded or integral part of the final medical device. IEC catalog
- Status. International Standard. IEC sells the full text. Consolidated with Amendment 1 (26 June 2015). IEC 62304:2006+A1:2015
- Certification. Does not cover validation and final release of the medical device, even when the medical device consists entirely of software. IEC catalog
Tool-by-requirement matrix
The full matrix lists each of the 8 tools against every IEC 61508 and IEC 62304 requirement area it is mapped to, with the quoted source in each cell. It is included in Pro ($49 per month or $490 per year) and Team.
Check where your program stands
The free readiness self-check asks 10 yes / no / not-sure questions, plus optional industry questions. Each one cites an official page. Your score and gap list show in the browser, with no email needed.