What is this standard about?
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.
The IEC 60601 series does not apply to:
- in vitro diagnostic equipment that does not fall within the definition of ME Equipment, which is covered by the IEC 61010 series (61)
- implatable parts of active implantable medical devices covered by the ISO 14708 series (69)
- medical gas pipeline sustems covered by ISO 7396-1 (68)
The object of this standard is to specify general requirements and to serve as the basis for particular standards.