Hi Vincent:
You asked:
1) Why is Class III electrical protection not accepted in IEC 60601-1, standard
for medical device safety?
According to IEC 60601-1, Annex 4:
The term “Class III equipment” is used in some other standards to identify
equipment that is
powered from a safety extra-low voltage (SELV) mains supply system. The term
Class III
equipment is not formally used in this standard. The BASIC SAFETY of Class III
equipment is
critically dependent on the installation and on other Class III equipment
connected thereto.
These factors are outside the control of the OPERATOR and this is considered to
be
unacceptable for ME EQUIPMENT. Additionally, limitation of voltage is not
sufficient to ensure
safety of the PATIENT. For these reasons, this standard does not recognize
Class III
construction.
My further understanding is that the only criterion for IEC 60601-1 electrical
safety is limitation of current irrespective of voltage. In my opinion, this
is appropriate for ME equipment.
Best regards,
Rich
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