IEC 60601-1:2020
Medical electrical equipment — Basic safety and essential performance
Electrical safety standard for electrical medical devices
- Category
- Harmonised standards
- Market
- European Union
- Applicable classes
- Class I medical device, Class IIa medical device, Class IIb medical device, Class III medical device
In practice
Mandatory for every electrical device. Covers leakage currents, insulation, electromagnetic compatibility and mechanical safety. Testing by accredited laboratories.
Official sources
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