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Starting to get Involved
Sorry, I didn't know how else to word the title...
I recently had a CE audit for a device that has a Part 2 standard not due to transition until later, the date not yet set for publication in the OJEU. I'm still claiming the 2nd edition of 60601-1 gives Presumption of Conformity to the Essential Requirements since the Part 2 standard determines the Transition date.
However, the auditor gave a nonconformity for not considering failure modes listed in the 3rd edition of 60601-1. The auditor's assessment of the risk management documentation, relevant for EN 60601-1:2006 compliance, doesn't seem appropriate at this time to me.
Is this appropriate?
There is a Risk Management program in place to 14971:2009 already and I'm writing an assessment for a transition plan to the third edition for this particular device in all markets. I'm hoping that assessing the regulation and having a plan for future based compliance with the third edition should be enough for that issue. This device has been 510k cleared and on the market in the USA for a while with no significant change so the EU will be driving compliance to the updated standard.
So I'd like to ask if there's something I'm missing? Like I said, I don't think that it's appropriate to assess RM to the third edition for this device right now but could the argument for assessment be that we should consider "state of the art", or something like that?
The Part 2 standard is tentatively scheduled to be published sometime mid-2013 per CENELEC and I'm trying to get some breathing room until we go all-in.
Thanks in advance!
I recently had a CE audit for a device that has a Part 2 standard not due to transition until later, the date not yet set for publication in the OJEU. I'm still claiming the 2nd edition of 60601-1 gives Presumption of Conformity to the Essential Requirements since the Part 2 standard determines the Transition date.
However, the auditor gave a nonconformity for not considering failure modes listed in the 3rd edition of 60601-1. The auditor's assessment of the risk management documentation, relevant for EN 60601-1:2006 compliance, doesn't seem appropriate at this time to me.
Is this appropriate?
There is a Risk Management program in place to 14971:2009 already and I'm writing an assessment for a transition plan to the third edition for this particular device in all markets. I'm hoping that assessing the regulation and having a plan for future based compliance with the third edition should be enough for that issue. This device has been 510k cleared and on the market in the USA for a while with no significant change so the EU will be driving compliance to the updated standard.
So I'd like to ask if there's something I'm missing? Like I said, I don't think that it's appropriate to assess RM to the third edition for this device right now but could the argument for assessment be that we should consider "state of the art", or something like that?
The Part 2 standard is tentatively scheduled to be published sometime mid-2013 per CENELEC and I'm trying to get some breathing room until we go all-in.
Thanks in advance!