DIN EN 60601-2-19 VDE 0750-2-19:2017-09

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.