Re: Current Products on the Market and IEC 60601 3rd Edition Safety Re-Test Requireme
Money grab's probably a bit of an overkill, the 3rd edition is causing a some financial pain and internal stress for the test labs as well. Efficient (profitable) testing only comes when things are reasonably predictable, and the 3rd edition is far from that.
But I think there is a more deeper question: is it reasonable? And, if not, what options do manufacturers have?
Recently I stumbled across two legal concepts in Europe: one is legal certainty, and the other is the principle of proportionality. These concepts sit above the regulation, so I think it's possible on both counts to explore the legality of the 3rd edition.
The real situation here is that the 3rd edition was made in all good faith, but there were too many new areas that were taken on, and as a result we have a standard that needs a lot of work (as with any new venture).
To apply such a standard to new designs is perhaps reasonable, because we have to start somewhere, to get feedback on how to improve.
However, to apply such a new and obviously faulty standard in retrospect is clearly out of proportion, and violates the concept of legal certainty.
Are there any manufacturers out there willing to take on the EU high courts?