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Class Fixed ME Equipment (US Deviation)

#1
Hi everyone,

I have a doubt regarding the clause 8.2.1 (Connection to a separate power source ). The clause says:

If ME EQUIPMENT is specified for connection to a separate power source, other than the SUPPLY MAINS, either the separate power source shall be considered as part of the ME EQUIPMENT and all relevant requirements of this standard shall apply, or the combination shall be considered as an ME SYSTEM. See also 7.2.5, 7.9.2.14, 5.5 f) and Clause 16.
U.S. Deviation: All FIXED ME EQUIPMENT and PERMANENTLY INSTALLED MEDICAL EQUIPMENT shall be CLASS I ME EQUIPMENT.

In my case the first part does not apply because I do not use a separate power source. I have a question regarding the U.S. Deviation, concerning the FIXED ME EQUIPMENT:
does this second part apply to ME EQUIPMENT in general or only to those specified in this clause, with separate power source?

Thank you
 
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