I'm presently challenged by a legacy product that was commercialized years ago, and the design (and design docs, DHF) have not changed since. But since the time of development, several standards have been updated (e.g. 60601-1, -1-2), and there have also been other harmonized standards added to the list.
My question is: in order to demonstrate "state-of-the-art", must we continually test to new standards?
I realise the standards are (in theory) voluntary, and perhaps justification can be made to not re-test to the latest standards (as well as any new harmonized standards)...but has anyone actually done this with NB approval? If so, what approach did you use to justify not complying with newest standards, and still be able to claim state-of-the-art?
If the general approach adopted by most manufacturers is to simply ensure that products are always tested to modern standards, I'm baulking at the potential logistics here. Suppose you have 20 products. When a major revision to a standard (e.g. 60601-1 2nd to 3rd edition), is the expectation that all products be retested? The cost would be incredible!
Anyway, just curious what approaches other have with respect to continually updated standards..
Any input much appreciated!
MM
My question is: in order to demonstrate "state-of-the-art", must we continually test to new standards?
I realise the standards are (in theory) voluntary, and perhaps justification can be made to not re-test to the latest standards (as well as any new harmonized standards)...but has anyone actually done this with NB approval? If so, what approach did you use to justify not complying with newest standards, and still be able to claim state-of-the-art?
If the general approach adopted by most manufacturers is to simply ensure that products are always tested to modern standards, I'm baulking at the potential logistics here. Suppose you have 20 products. When a major revision to a standard (e.g. 60601-1 2nd to 3rd edition), is the expectation that all products be retested? The cost would be incredible!
Anyway, just curious what approaches other have with respect to continually updated standards..
Any input much appreciated!
MM