From: Doug Sutherland (wearable_at_earthlink.net)
Date: 2001-12-19 08:34:12
C. Safe Electrical Design Criteria
1. Leakage Current. Specify measured patient to ground and
chassis to ground leakage current of the device. How does
it compare with industry standards (e.g., IEC 601-1, or
UL 2601)? (See Ref. 4)
2. Safety Standard. Indicate the extent to which the device
conforms to any industry standard (i.e, UL 2601 or any
other electrical safety standard).
3. Isolation. The manufacturer should specify the means by
which isolation from commercial power and power line
ground (return) is achieved. This may be achieved by:
a. labeling that claims that the device meets UL 2601,
or some other appropriate industry standard.
b. employing battery operation. (Provide assurance that
device cannot be operated with a line-powered battery
charger.)
c. the use of an isolation transformer, or equivalent
techniques, that provide fault protection by redundant
insulation. (UL 2601 specifies several acceptable
transformer designs for patient isolation).
http://www.fda.gov/cdrh/ode/eedev.html
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