Routine test for MD finished product

J

jayanthi

#1
Hi
We already tested our MD prototype for IEC 60601./Now for regular production, What are the test we have to make it routine in regular production to comply with IEC 60601. Is there any requirement in IEC std
?
 
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Marcelo

Inactive Registered Visitor
#2
It depends on what the regulatory system requires you to do. Generally, you need to perform leakage current, protective earthing and dielectric strength, cause this is mentioned in the second edition of IEC 60601 and thus has historically been the rouutine tests required by regulators (the third edition makes no mention to routine tests of the finished product).

From a response from another (http://elsmar.com/Forums/showthread.php?t=38433) thread:

The problem with dielectric strenght is that it´s a very destructive test. In Brazil, we are changing the routine tests required. We´ll begin using IEC 62353, which uses insulation resistance testing in place of the hipot test. Insulation resistance also measure the quality of the insulatio nbarriers, but does not damage the equipment.

You might use a rationale of this kind for justifying not implementing routine dielectric strenght testing, and then ask what your notified body thinks about it.
 
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