Bill, 

There is no requirement by any agency to conduct a Production-Line Leakage
Test. I think, it is up to the manufacturer to decide whether this test or any
other test, including Production-Line Dielectric and Earth Continuity is
needed. If manufacturer has a good quality system including receiving,
in-process and final production, then why would someone need to spend money
and time on production-line testing? 


I know that most UL standards require Production-Line Dielectric Strength and
Earth Continuity Tests. On the other side of the ocean, most European
standards do not require these type of tests and it is up to the manufacturer
to show the test house that such testing is not required. 


Peter 


 FastWave <[email protected]> wrote: 



Does anybody know any Certification Agencies and/or Standards anywhere in
the world requiring Production Line Leakage Current Testing on Electrical
Medical Products? If so, does anybody have it in writing?

Thanks for the help,

Bill Bisenius
ED&D, Inc.
[email protected] 
www.productsafet.com 


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