When is Compliance required for 4th edition IEC 60601-1-2

[bassa]

Hello all,

Since our device did not pass the tests for EMC (60601-1-2) we have to improve it.
The device was tested as a Class A device, (not for domestic use)
The company that is perfoming the tests, advised us to test the device as Class B, conform the new 4th edition requirements.

We are unsure what to do, is it still possible to stick to the 3rd edition?
When/If this 4th edition comes out in November this year, when is compliance required?

Thanks for your advice.

 

[Stijloor]

Re: When is Compliance required for 4th edition 60601-1-2

A Quick Bump!

Can someone help?

Thank you very much!!

 

[Pads38]

Re: When is Compliance required for 4th edition 60601-1-2

From the IEC website for SC62A (the committee responsible) 60601-1-2 Ed 4 is at the ADIS stage (approved for voting to create the FDIS {Final Draft for Circulation}). A standard at this stage should be stable with only minor editorial changes to occur before the finished standard is published.

It also shows that the vote was scheduled for June. It may be that the website needs to be updated.

Publication date is shown as November of this year. The programme to create this Ed 4 started in 2006.

To answer the question on when it will replace the 2007 version - that depends upon the market you are dealing with. If you are considering the EU situation, then once IEC publish Ed 4 it will be scrutinised by CEN/CENELEC who then publish it as an 'EN' standard. It then can be listed in the 'Official Journal of the EU' which makes it an official standard for European compliance. This process would likely take from 6 months to a year.

There is, usually, a 3 year overlap period before the old version ceases to be usable to show compliance.

I don't know the details of the revised standard, but am aware that 60601-1-11 (MEE for use at home) demands Class B, so that may have been incorporated within -1-2.

From an (re)-engineering basis it would, probably, make sense to use the forthcoming standard to set your requirements even if you then use the 2007 version to claim compliance. That way you are more likely to "future proof" your device. With Ed 4 so late in development it is highly unlikely to significantly change now.

 

[Peter Selvey]

Re: When is Compliance required for 4th edition 60601-1-2

I am surprised to hear that Class B will be required, I would like to see this in writing.

As I understand, Class A is important for domestic because a house may be located far away from the transmission tower, so they get for example a weak TV signal. That means it is easier for an electrical device to interfere with the weak signal. But in a clinical (or any business) situation receiving TV/Radio signals are not considered a primary concern, and the business is anyhow more likely to be located near a strong transmission source.

It is sometimes thought that Class A is safer as the emission is lower. But that is a mistake; the signal levels are so low that they are negligible from an immunity point of view. The immunity tests are designed around transmitting devices, which are in the order of V or V/m, while Class A limits are in the order of uV or uV/m. If a medical device was affected by Class B emissions, it would really be an incredibly weak device.

 

[Pads38]

The Class A / B thing is often a 'bit of a fudge'. We commonly specify that our equipment is Class A, thus stating that it is not suitable for "domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes".

This, for us, makes sense as our devices are for professional clinic based use. The "grey" area comes from something like a primary care physicians office, which may very well be in a domestic area.

To be clear, the Class A / B classification only applies to the Emissions part of the testing. It derives from the base CISPR 11 standard. When you receive the spectrum analyser plot test results you will probably see 2 coloured lines marked; these mark the 'pass levels' with the Class A being about 10dB higher, depending upon the type of receiver used for the tests.

It is assumed (by CISPR) that domestic settings have equipment that is less well protected from emissions (such as the TV that Peter notes) as well as having a less-robust power supply network than a location where ISM (Industrial Scientific Medical) equipment would typically be used.

The justification for Class A vs. B is dependent upon your device type and how sure you can be as to where it will be used. More 'Risk Analysis' of course!

As far as I am aware, only 60601-1-11 demands Class B, not surprising for the standard for home-use MEE.

 

[Peter Selvey]

I just noticed that I got the Class A and B mixed in my post.

I would think that choosing Class A or Class B is not a subject for risk management. The only significant risk is interference with a weak TV or radio signal, not with other medical devices.

You might try to argue that this is still a significant risk, e.g. maybe the TV is important for emergency info. But chances are that if the signal is so weak that +10dB emission will make a difference, then reception is going to be a bit dodgy anyway e.g. cloud cover, someone walking around the room etc might just as easily interfere with reception.

Rather, it is just an annoyance issue. Which is of course important, but just not an issue in medical device regulation or risk management.