The scope of IEC 60601-1 is limited to MEE and MES. Typical OFF/ITE/AV_ICT Equipment does not meet the 60601-1 definition of MEE/MES and cannot be evaluated and certified to IEC 60601-1 under the CB scheme.
Decision
The scope of IEC 60601-1 is limited to MEE and MES. Typical OFF/ITE/AV_ICT Equipment does not meet the 60601-1 definition of MEE/MES and cannot be evaluated and certified to IEC 60601-1 under the CB scheme.
See IECEE OD-2055 (Operational Document on Medical Electrical Equipment in the CB Scheme according to the IEC 60601 and ISO/IEC 80601 Series of Standards) for specific rules associated with power supply and component/subassemblies certifications under the CB Scheme.
Explanatory notes
Medical electrical equipment and medical electrical systems are defined terms in IEC 60601-1. Currently, different non-medical equipment is tested and certified to IEC 60601-1. This includes off-the-shelf PCs, monitors, routers etc. OFF/ITE/AV_ICT equipment not meeting the definition of MEE/MES as per clause 3.63 and 3.64 is not covered by the scope of the standard.
Clause 16 covers medical electrical system (MES) requirements and allows IEC 60950-1 or IEC 62368-1 equipment to be used inside or in combination with MEE / MES under certain conditions.
Additionally, Annex I provide examples on the use of such equipment together or inside MEE. We recognize that manufactures may wish to provide OFF/ITE/AV_ICT equipment that meet means of patient protection in order to more easily combine in medical electrical systems (MES). However, OD-2055 edition 2.3 does not have a framework for consistent application of requirements for these situations.
Note while it is recognized that there may be a need to consider requirements for OFF/ITE/AV_ICT Equipment to be evaluated to aspects of 60601-1, there are no agreed methodology for these evaluations in OD-2055 and updates to the document would be required in order to allow for CB certifications for OFF/ITE/AV_ICT Equipment to 60601-1.
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