IEC 60601-1 - Medical Electrical Equipment Safety 4.5: Equivalent safety for ME equipment or ME systems (alternative risk control measures or test methods)

What does 4.5 require?

Where the standard gives a requirement, a risk control measure or a test method for a particular risk, an alternative is acceptable if the manufacturer can justify, using scientific data, clinical opinion or studies comparing it with the specified measure or method, that the residual risk from the alternative is acceptable and comparable to or lower than the residual risk from applying the standard; alternatives may exceed specified limits where compensating measures are provided; compliance is checked by inspecting the risk management file.