International Electrotechnical Commission
Consensus standards for medical electrical equipment (60601), device software life cycles (62304), and usability engineering (62366).
WHAT IEC COVERS
The International Electrotechnical Commission publishes standards for electrical, electronic, and related technologies. In the regulated space its standards govern medical electrical equipment safety, medical device software lifecycles, and usability engineering.
WHERE IT SITS INTERNATIONALLY
IEC works jointly with ISO in several areas, and its standards are widely harmonised under EU MDR and recognised by FDA as consensus standards. In practice a device software submission is built from an interlocking set — ISO 13485 for the quality system, ISO 14971 for risk, IEC 62304 for the lifecycle, and IEC 62366-1 for use — and a gap in any one of them shows up as a deficiency in the others.
HOW ITS REQUIREMENTS BITE
Like ISO, IEC does not regulate. Its standards are applied through conformity assessment and become effectively binding when regulators reference them — IEC 60601 for electrical safety and IEC 62304 for software lifecycle are expected in device submissions in both the US and EU.
WHAT IEC PUBLISHES
- 01IEC 62304 — medical device software lifecycle processes, with safety classes A/B/C
- 02IEC 60601 series — safety and essential performance of medical electrical equipment
- 03IEC 62366-1 — usability engineering for medical devices
- 04IEC 61010 — safety for laboratory equipment
- 05IEC 80001 — risk management for IT networks incorporating medical devices
WHAT PRACTITIONERS GET WRONG
- ›IEC 62304 safety classes A/B/C determine how much lifecycle rigour a software item needs — and the class is argued from what happens if the software fails, not from how complex it is.
- ›IEC 62304 covers the software lifecycle; ISO 14971 covers the risk management that feeds it — you need both, and the classification depends on the 14971 analysis.
- ›IEC 60601 has particular standards for specific device types layered on top of the general standard; meeting only the general standard is a common submission gap.
- ›Usability engineering under IEC 62366-1 is frequently underdone, yet use-related hazards are a leading source of device incidents.
- ›Software of unknown provenance — third-party libraries and OTS components — must be identified and risk-assessed, not silently inherited.
IEC STANDARDS SPEQ DECODES · 2
DISCIPLINES IN IEC’S REMIT
Track IEC — and every regulator that matters
New rules, guidance, enforcement, and inspection signals from International Electrotechnical Commission and its peers worldwide, distilled into the free Weekly GxP Briefing.