Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
(IEC 60601-2-19:2020); German version EN IEC 60601-2-19:2021 Class/Status:
VDE Art. No.: 0701386
This particular standard specifies safety requirements for infant incubators but alternate methods of compliance with a specific clause by demonstrating equivalent safety will not be judged as non-compliant if the manufacturer has demonstrated in his risk management file that the risk presented by the hazard has been found to be of an acceptable level when weighed against the benefit of treatment from the device.
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