Hi ,
I need some advise regarding compliance testing done by UL. We are intending to design a biomedical device ( an EKG machine) . And we want UL to do compliance testing aganist the following standards
- UL 60601-1 (2006)
- IEC / EN 60601-1 (1998+A1+A2)
- ANSI / AAMI ES60601-1 ( 2005+C1+A2)
- IEC EN 60601-1 (2005/2006 + C1+ C2) ( Europe, CE)
- 60601-2-26(2002)
I have no information about the testing methods or what kind of test UL will perform on this device. I do not know about reasons that they can use to reject the device.
EKG machine:
- Operated by UL approved 3.7V, 1A, LiIon battery. Battery can be charged by a UL approved charger. But when the battery is charging, EKG machine will be completely shut down by software. I am using the following "power connector"
Is this connector a good choice?
- I am using the following box
I do not know what should be the ingress ratings of the box and flammability ratings. Any advise!
I have gathered following knowledge so far about the tests
- Single Fault Condition : I am not able to find any clear answer for that. Can anyone give a simple to undertsaned explanation?
- Ingress rating test: do not know how will they test
- EMC test
- Enclosuer mechanical robustness test.
What other tests should I keep in mind before we start designing this machine.
Jess