IEC 60601-1 - Medical Electrical Equipment Safety
Clauses 6 to 7: classification, identification, marking and documents – IEC 60601-1 - Medical Electrical Equipment Safety

IEC 60601-1 - Medical Electrical Equipment Safety 6.2: Protection against electric shock

What does 6.2 require?

Equipment energised from an external electrical power source is classified as class I or class II; other equipment as internally powered, and internally powered equipment with a means of mains connection meets class I or II requirements while connected and internally powered requirements while not; applied parts are classified as type B, BF or CF and may additionally be classified as defibrillation-proof.

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