I think we're at crossed purposes here - we're discussing routine testing of medical devices, i.e. 62353, not manufacture, and I'm comparing aspects of the standard we use for routine tests, a subset of 60601-1, with aspects of the 62353 standard and thinking about the possibility of incompatibility between them if a department uses both standards for acceptance, evaluation and routine tests.
That surely will lead to confusion. Now imagine devices tested according to the new 60601, in which manufacturers have the option to reduce or increase the limits as needed and if the risk remains acceptable.
That is exactly my argument. My problem with 62353 being an independant standard having the potential to have different limits for leakage compared to 60601-1 is that we are testing the same devices using the same methods hence I expect the leakages to be the same under NC at least. Have you looked at 62353 and compared to 60601-1 3rd edition?
When one standard changes limits then the other must surely have compatible limits considering leakages at least? Also earth bond, IR, etc, etc. If you look at the 62353 standard are all the leakage limits equal to those for 60601-1 3rd edition under NC at least? If not then why not? Are earth bond limits the same under all conditions?
Yes 60601-1 is a manufacturing standard for medical devices but, de-facto, it has become established as a standard whose non-destructive tests and limits are used for routine testing of medical devices in the field. One feature that is not usually included in such devices (I've used many) is Hi-pot testing; this is generally reserved for use in manufacturing since it's a requirement to test assemblies during development/manufacture and not generally in the field.
The truth is,they´re trying to fix a problem - the lack of a strong link between pre and post production, that in reality can only be solved by one player - the manufacturer.
Essentially I agree but it would go some way to fix the problem if basic leakage and earth bond limits were unified for the same type of tests. Also if both standards were updated concurrently or 62353 were a subset of a 60601-1 standard that included aspects of servicing/maintenance provision generally.
I'd like to see the manufacturers test every device out there - it's got to be done with the cooperation of those performing testing in the field, 3rd parties and purchasers servicing organisations. All interested parties in fact - not a range of manufacturers trying to sell products on the back of standards, in my opinion.