One of the biggest points that most seem to miss or not realise the significance of, is the need to compare the test results with previous results.
This is not done in 60601 as all that matters is whether it passes or fails the limit values.
In 62353 you have to look at previous test values to see if there has been a significant change which would indicate a potential failure. In fact many manufactures set limits as to how much a value may change from the initial factory or acceptance test value. As an example a Siemens ultrasound unit is only allowed an increase in any leakage value of 1.5 times the initial value or 10uA whichever is the greater! This would never be picked up in an IEC 60601 test!
Would you want a probe used on your family if it displayed a leakage value of 4500uA? This is a pass for 60601 but would 100% fail a Siemens ultrasound safety tests as the initial value would have been about 4uA!
I understand there are those that don't like change and may see performing fewer tests (as required by 62353) as somehow unsafe but in fact if performed correctly they are in fact much safer that those of 60601 as they will pick up faults that 60601 would miss.
Open your eyes and your mind and embrace the new standard.
I particularly like the Alternative test method as, where it is suitable for use, it works really well and saves lots of time booting up and down PC based devices between tests. Many don't accept the equipment leakage values it reveals but in fact they directly correlate to the 60601 open neutral tests!
I suggest those who dislike the new standard actually obtain a tester that works to 62353 and go back to basics and conduct some tests of their own.
You also need to look at the MHRA DB2006(5) document (which supersedes all others) and note that it says to use an appropriate standard but not 60601. As the only appropriate standard in the UK is BS EN 62353 I suggest al get on board as soon as possible.
