Sequence of testing in IEC 60601-1

[krishnasaini19]

Hello everyone
This is my first post on elsmar. I am a test engineer(recently joined and new in medical standards).
As per clause 5.8 of IEC 60601-1, it is recommended to do testing in the sequence given in annex B and annex B is saying to do Humidity preconditioning treatment(Cl. 5.7) after risk management related clauses. When I am seeing old reports to take some reference, people are doing touch current tests(Cl. 8.7) both before and after Humidity test.
Is this the right way of doing touch current testing?

 

[Benjamin Weber]

When you look at Annex B.20 to B.22, wou will see that the sequence recommends to perform leakage current tests (this includes touch currents) at operating temperature before and after humidity preconditioning. This additionally stated in cl. 8.7.1 "Leakage currents and patient auxiliary currents - General requirements":

"- at operating temperature and following the humidity preconditioning treatment, as described in 5.7;"

But actually I don't see the problem in the sequence in relation to the risk management tests? You first check the RM in order to determine where touch current or patien leakage current limits shall be applied and after that you perform the leakage current tests.

 

[krishnasaini19]

yeah, B.20 to B.21 clarifies things, but B.3 is confusing which says to perform 5.1 to 5.7(inclusive).

Thank you so much.