Thanks for that JB,
As you've indicated 62353 uses the same leakage limits but there are important deviations from the standard that can cause confusion when moving between 60601-1 and 62353.
I think it's useful to discuss the real issues rather than just skirt around them. I think I have an idea why the UK experts were unhappy with 62353 - and that's my opinion coming from a hands-on perspective and not academic or regulatory.
Why do we believe that IEC 60601 is better then IEC 62353?
I don't believe I've ever made that comment. Neither have I suggested that there isn't a place for 62353. All I want is less confusion RE: safety testing standards, not more. Actually I think the introduction of explicit IR testing is a good idea for workers at the coalface like myself.
I think the changes you've described are significant RE: patient safety, however I'll need time to have a think about it. Remember I'm not involved with developing standards just trying to apply them to my day job in the real-world, rather than voting on my preferences.
The 3rd edition Earth Leakage limit of 5mA (NC) and 10mA (SFC) are potentially dangerous and can only be tested safely on an isolated supply. This is not always possible when testing “on location” as carrying such transformer would require a decent trolley. The new pass/fail limits on normal non-isolated supplies are potentially fatal (macroshock) within the limits of IEC 60601.
I notice the Rigel 288s I've seen are enabled for 3rd edition 60601-1 limits for 62353 direct tests 1). does this mean that unsafe practices are being encouraged when using this device 2). does this device then comply with the 62353 standard itself?
More often than not people pick and mix from IEC 60601 (see previous forums), make there own tests up (within the limits of safety analysers), do not test on TN systems (mainly outside UK) or power the safety analyser from an isolated supply.
Users like myself are somewhat captive when considering the tests that manufacturers of electrical safety testers provide built into their devices. The majority of operators probably just use automated tests built-in by the tester manufacturer. Are you saying that Rigel, for example, have previously manufactured testers that are not up to routine testing or that they perform non 60601-1 compliant tests?
I think you're forgetting that we do not aim to type-test devices and this is not what medical electrical safety testers on the general market try to achieve - we are looking for reassurance that safety of devices we tests after repairs/routinely, whatever, is acceptable.
Irrespective of this, however, we need to ensure that routine safety testing methods ensure an equivalent level of safety for the patient. That's why I'm reticent about endorsing a method that doesn't necesarily agree with the general standards RE: basic leakage limits (forget the relatively insignificant variations in mains that are required during some type-testing activities) nevermind the more complex stuff.
