With regard to transformer construction, CLAUSE-57.9.4(e) of EN-60601-1
General Requirements for Safety of Medical Electrical Equipment requires:-

"In transformers with REINFORCED INSULATION or DOUBLE INSULATION the
insulation between 1ary and 2ary windings shalll consist of -
-  1 insulation layer having thickness at least 1mm, or
-  at least 2 insulation layers with total thickness not less than 0.3mm, or
-  3 layers provided each combination of 2 layers can withstand the
dielectric strenght test for REINFORCED INSULATION"

Can anyone explain ther rationale behind these requirements ?

Thanks.

Ged Dean
Nottingham City Hospital.



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