Devices

IEC 60601-1-8

IEC 60601-1-8 — Requirements, tests and guidance for alarm systems in medical electrical equipment

International Electrotechnical CommissionLatest · Edition 2.2 (2020)Referenced by FDA and by EU MDR for medical electrical equipment.

Scope

60601-1-8 is the collateral safety standard that governs how audible and visual alarms behave on medical devices. It defines alarm priorities, sound characteristics, information content, and requirements for delegating and logging alarms — the reason patient monitors across vendors sound broadly similar.

Where it applies in the room

  • Alarm priorities (high, medium, low, information)
  • Alarm-signal delegation to a distributed system
  • Alarm inactivation states and their indication
  • Alarm-system logs and history

Key requirements at a glance

Priority levelsThree action-required priorities plus information signals, with distinct visual and auditory cues.
Distributed alarmsDelegated alarms must preserve priority and be acknowledged at the delegating device.
Alarm logDevices must maintain a tamper-evident record of alarm events.

Summarized for reference. Consult the source document for the definitive text.

Source & further reading

Also known as

  • IEC 60601-1-8
  • 60601-1-8

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