DIN EN 60601-1-11 VDE 0750-1-11:2016-04

This International Standard applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems, hereafter referred to as ME equipment and ME systems that are intended, as indicated in the instructions for use by their manufacturer, for use in the home healthcare environment, as defined in 3.1, regardless of whether the ME equipment or ME system is intended for use by a lay operator or by trained healthcare personnel.