This International Standard applies to testing of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL
ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS, or parts of such
equipment or systems, which comply with IEC 60601-1, before PUTTING INTO SERVICE, during
MAINTENANCE, INSPECTION, SERVICING and after REPAIR or on occasion of RECURRENT TESTS to
assess the safety of such ME EQUIPMENT or ME SYSTEMS or parts thereof. For equipment not
built to IEC 60601-1 these requirements may be used taking into account the safety standards
for the design and information in the instructions for use of that equipment.
This standard contains tables with allowable values relating to different editions of
IEC 60601-1. For the purpose of this standard, the application of measuring methods is
independent of the edition according to which the ME EQUIPMENT OR ME SYSTEM is designed.
This standard contains:
– "general requirements", which contain clauses of general concern, and
– "particular requirements", further clauses handling special types of ME EQUIPMENT or
ME SYSTEMS and applying in connection with the "General requirements".
NOTE 1 At this stage, there are no particular requirements.
This standard is not suitable to assess whether ME EQUIPMENT or ME SYSTEMS or any other
equipment comply with the relevant standards for their design.
This standard does not define requirements for REPAIR, exchange of components and
MODIFICATION of ME EQUIPMENT or ME SYSTEMS.
NOTE 2 All MAINTENANCE, INSPECTION, SERVICING, and REPAIR done in accordance with MANUFACTURER's
instructions maintain the conformity to the standard used for the design of the equipment. Otherwise conformity to
applicable requirements have to be assessed and verified.
This standard is also applicable to tests after REPAIR. The testing shall be defined according to
the extent of work performed and applicable guidance from the MANUFACTURER.
This standard is not intended to define time intervals for RECURRENT TESTS. If such intervals
are not defined by the MANUFACTURER, Annex F may be used to help establish such intervals.