EN60601-1 2. or 3. edition - Question

[KESADV]

hello forum

I'm working in the medical laser business, and have to comply to EN60601-2-22 part 2 standard for laser eq. But the IEC60601-2-22 3.edition has not yet become a EN standard only IEC.
Am I then using both the "old" EN60601-1 2:1990 that has DOW 2012, and the EN60601-2-22:1996? And then going for a new CE marking in just half a year, when both hopefully are in 3.editions?

thanks
KESADV

 

[Marc]

A quick "Bump". Can anyone help with this one? Please - Help if you can. My Thanks in advance!

 

[Peter Selvey]

I have heard different interpretations on this from different NBs. Ultimately however, NBs are private organizations and are not authorised to give kind of important interpretation, and they have often given wrong advice in the past that conflicted with later official announcements from the EU commission or other public agencies.

So far the official advice is from CEN indicates that where standards form a package, the date of withdrawal should follow the last standard in a package. Unfortunately I cannot find anything yet from EU commission.

Obviously from a practical implementation this also makes sense to treat standards as a package.

In one sense, when a particular standard applies to a medical device, the general standard ceases to exist as a harmonized standard. For example, EN 60601-2-22:1996 heavily modifies the creepage and clearance tables in EN 60601-1:1990. So, you no longer can claim you "comply" with EN 60601-1:1990 as such, only the modified version of EN 60601-1:1990.

A similar argument also applies to collaterals, since particulars take priority over collaterals and often modify the collaterals.

Thus the only standard you can truly claim full compliance without qualification is the particular standard. By inference, a claim of compliance with the particular incorporates the compliance with modified versions of the general and collaterals, as a package.

Thus, the date of withdrawal of the particular forms the withdrawal date of the whole package.

 

[KESADV]

Thanks Peter,

for your fast reply. You are right, the clearance are different in 60601-2-22, but I think otherwise the standard is an extention to the basic standard.
The reason that I would like to use 3.edition of 60601-1 is that a lot of the collateral standards has been updated, and because some of the modules I use in my Laser System is certified by using 3. edition. Risk management etc.
I will buy the IEC60601-2-22 to see what difference there realy is. Do you have any idea why it has been stock at Cenelec since 2005?

/Keld

 

[Peter Selvey]

Certainly if you want to use the 3rd edition package, then it should be OK. I assumed that you would like to delay the 3rd edition as much as possible, thus I was providing a defence for this case.

From a formal perspective, you should write a short justification why a non-harmonized standard (IEC 60601-2-22:2007) still meets the essential requirements, but this is fairly obvious as being OK, and unlikely to be challenged. Even so, the law requires such "alternate solutions" to be documented formally.

It seems from a quick scan that most of the critical requirements are the same, I can see a new requirement for 50% limit in SFC for Class 3B and 4 lasers (see 201.13.2.101), previously this was effectively 100%. This I believe reflects the improvement in control and monitoring of laser power e.g. by split mirror.

 

[KESADV]

Thanks a lot Peter,
I appreciate your answers very much
regards
Keld