Does EN 60601-1 include 60601-1-2 from a contract point of view

Dear Forum,

A contract manufacturer is designing and manufacturing a device for us which we have specified shall be EN 60601-1 compliant.

Now, during our product testing this module failed a test in EN 60601-1-2 (EMC).

We obviously did a mistake by not explicitly specifying 60601-1-2, however, in my opinion, "compliance to EN 60601-1" means "compliance to 60601-1 and its relevant substandards"

Does anyone share my opinion here?


regards
t.

Hi t,

In my experience we as company have designated that our ME products are tested to (and comply with) EN 60601-1 and separately that they are tested to (and comply with) EN 60601-1-2 (EMC). So were have two separate certifications. We don’t then have an issue with your point i.e. "compliance to EN 60601-1" means "compliance to 60601-1 and its relevant sub-standards". I must admit it seems complicated – do you then have to show specifically that the ME also complies with the other collateral (relevant) standards e.g. EN 60601-1-6 (Usability)? Or is this covered when you conduct a Risk Assessment to ISO14971. Don’t know if this helps.

Steve

temujin said:

(...) "compliance to EN 60601-1" means "compliance to 60601-1 and its relevant substandards". Does anyone share my opinion here?

Click to expand...

I don't. Your subcontractor would have to be able to read your mind to know which of the many substandards are "relevant". Would that apply to substandards that are created by IEC, but are not EN? Would it apply to substandards that are identified as 60601-2 instead of 60601-1?

Mistakes are always regrettable, of course. As seen from the perspective of their own contract review process and their own desire to maximize their customers' satisfaction, your supplier is probably kicking themselves for not having done a better job of asking at the beginning of the project what you intended to do with the product they would deliver, and therefore whether what you had specified was actually what you really wanted and needed. If nothing else, such contract review should be SOP for their salespeople as an essential tool for maximizing the scope of their capabilities that are part of each sale.

Given that they probably regret the outcome almost as much as you, perhaps they and you can reach an accommodation on fixing the current problem.

thanks, well, there are not really a lot of money involved, so we are not going to push this very far...

I still think that 60601-1-2 is a special category (not like the 60601-2-xx standards) I.e. 60601-1-2 is referred to explicitly in 60601-1/A2, so it is hard to claim compliance to the base standard without including the EMC part.

I´m sure we will come to terms with the supplier.

t.