Therapy equipment (ICS code(s): 11.040.60)

The draft of the Egyptian Standard ES 5807 for " medical electrical equipment - particular requirements for the basic safety and essential performance of infant phototherapy equipment".; (31 page(s), in Arabic)

The draft of the Egyptian standard ES 5807 specifies safety requirements for infant phototherapy equipment, 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. Worth mentioning is that this draft standard is technically identical with IEC 60601-2-50:2020.