IEC 60601-2-25 Reference to 60601-1 2nd Edition

EMengineer

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#1
Hi,

Standard 60601-2-25:1993+A1:1999 is valid until 2018, but it has reference to old void 60601-1:1988 2nd edition medical standard. So, can I use 2nd ed. 601 as general standard of 601-2-25 for ecg testing? I don't have old 601 so I wonder if it is worth buying one. Or 2nd and 3rd ed. 601 tests (defibrillation tests, leakage measurement) used for ecg approval are the same?
 
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#2
It somewhat depends what you are trying to do. The electrical tests are all but identical from Edition 2 to 3, (some terms have changed - enclosure leakage = touch current) but fundamentally they remain the same.

What you may find useful is IEC TR 62348:2006. This contains tables that 'map' between the requirements of Edition 2 and 3 (both directions). Although the 2006 version is marked as withdrawn it is still available as a free download.

https://webstore.iec.ch/publication/20459
 
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