IEC 60601-1 - Medical Electrical Equipment Safety
Clauses 11 to 13: temperatures, fire, outputs, hazardous situations and fault conditions – IEC 60601-1 - Medical Electrical Equipment Safety

IEC 60601-1 - Medical Electrical Equipment Safety 11.5: 11.5 ME equipment and ME systems intended for use in conjunction with flammable agents

Where equipment or a system is meant to be used together with flammable agents, the manufacturer covers in its risk management process the possibility of fire and the associated mitigations, checked by inspecting the risk management file.

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