On datasheets for new medical power supplies, you might
notice that there is no mention of UL 60601-1, but a new safety standard called
ANSI/AAMI ES 60601-1:2005 is being called out.
So what has happened?
ES 60601-1 is in fact identical to IEC 60601-1 but with U.S. deviations
to comply with U.S. National Electric Code.
UL is now using that standard to write their reports and is the standard
used in the US to comply to the 3rd edition.
The FDA now officially recognizes ANSI/AAMI ES 60601-1:2005
in the Federal Register
Older power supplies are calling up this new standard, and
will also reference the older UL 60601-1 standards to keep continuity for
existing customers with UL’s “grandfather” clause.
ANSI is the American National Standards Institute. AAMI is the Association for the Advancement
of Medical Instrumentation.
Power Guy
