They state a minimum (of 200 mA), but fail to give a maximum? What sort of Standard is that?
A flexible one! Probably an oversight but since any testing is referenced back to IEC 60601 then the maximum can assumed to be 25A.
I would suggest a maximum of 13 Amps (or so) thereby allowing 10 Amps to become available as the standard practice for those of us who believe in carrying out tests in accordance with the "traditional" approach.
The 10A limit would be to include a 10A test current as used by many current 60601 testers.
"Requiring" a comparison of test results, and actually getting them compared are two completely different things, of course. But are we going back, then, to filling up computer files with reams of EST data? I'm asking that for two reasons:-
1) That idea has been roundly "kicked into touch" here (on the forum) before
... and ...
2) I'm wondering if I need to include provision for those records in my database
... so ...
... which results does 62353 require to be recorded, and compared?:-
1) All of them?
2) A sub-set only?
3) In any case, which ones are they?
Without comprehensive record keeping any litigation as a result of an incident would be difficult to defend without the data to back it up. A label stuck on a device saying it had passed a safety test may not stand up very well in court!
Without a comparison of test data, in particular leakage currents, it is not really acceptable to say a device is safe. Take an ultrasound probe, on previous tests it may have a leakage of 10uA but on the next test it has a leakage of 1500uA. Still within the 5000uA limit but obviously is failing. Are you happy for this to be classed as a pass?
The data to be stored is quite small and the actual data to be compared equally small (PE resistance, equipment leakage, applied part leakage BF & CF). Since any good software package will perform the comparison for you and alert if the values have changed significantly it is not all that onerous.
In countries such as Germany record keeping has been compulsory for more than 10 years now and I don't think they are sinking under a pile of data.
Given data storage on a computer is very cheap now and automated testers have been with us for some time there really is no excuse for poor or non existent record keeping.
