IEC 60601-1 ME equipment or ME system

hedazhuang

Registered
Hello, I have an internal battery powered ME equipment which will be connected to a charger comply with the EN 60601-1 while charging. How will this charger be defined? An accessory to the ME equipment and together as a whole ME equipment, or defined as two ME equipments and together as a ME system?
Thank you.
 

Benjamin Weber

Trusted Information Resource
IEC 60601-1, cl. 7.9.2.3 - "ME EQUIPMENT specified for connection to a separate power supply"
If ME EQUIPMENT is intended for connection to a separate power supply, either the power
supply shall be specified as part of the ME EQUIPMENT or the combination shall be specified as
an ME SYSTEM. The instructions for use shall state this specification.

You have the choice ;-) And it actually doesn't make a big difference.
 
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