July 31, 2014
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 U.S. 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.