What EMC 60601-1-2 version to use with 60601-2-47

[SHunter]

Hello,

We are recertifying for MDR with our portable ECG holter device (currently our device has medical CE certification under MDD).
Since we have a ambulatory electrocardiographic system, we need to use the latest IEC60601-2-47:2012.
Now we have a discussion with our notified body on which version of IEC60601-1-2 we must use.

In according to Clause 201.2 (Normative references) of 60601-2-47:2012, we need the IEC60601-1-2:2007 version.
Our notified body states we need the latest state of the art. Since IEC60601-1-2:2207 is withdrawn, our notified body states that we need to use the harmonized IEC60601-1-2:2014.

Can we legally still use IEC60601-1-2:2007, since this is the normative reference for IEC60601-2-47:2012?
Our device has passed all the IEC60601-1-2:2007 tests. Testing against IEC60601-1-2:2014 would implement extra time and costs and potential design changes, so this is not our preferred route.

Any help would really be great, since we could not find any rational on how to handle this situation.

Thanks,
Sander

 

[yodon]

Apologies for the delay replying.

"Legally" is probably not the right term. (In theory) Compliance to a particular standard is optional. That aside, there is the concept of 'state of the art' and with -1-2 being both superseded by a later revision AND the fact that :2014 is the harmonized version, I'd say compliance to the :2007 version would be a tough row to hoe. You *might* be able to do a gap analysis and try to justify why the results from :2007 tests are suitable but that's a gamble at best.

 

[Benjamin Weber]

1. IEC does not really withdraw old standard revisions, they are marked as revised. There also usually no transitional periods given in IEC versions. This is usually only part of national versions, such as EN. If the national legislation still require compliance with such a revised standard, IEC cannot "prohibit" that. (Think of 60601-1 Ed. 2.0 which was required by China until 2020 or 2021, not sure about the exact year)
2. IEC standards are usually not harmonized with European directives/regulations, but EN versions are, which can have substantial national differences. (But: I don't think that there are such differences between the IEC and EN versions of 60601-1-2:2014).
3. Neither the IEC nor the EN versions of 60601-1-2:2014 are harmonized with MDR (in contrast to MDD).
4. If a standard refers to a dated version of another standard, this dated version must be applied to be compliant with the referring standard.
5. If the notified body refers to the "state-of-the-art" version of a standard, they definitely can do so. Espacially if there is no harmonized version of the standard for MDR!

What does this mean in summary:

1. If the particular standard refers a (out-)dated version of 60601-1-2, you still have to apply the old version.
2. If the notified body requires you to be compliant with the latest version, you should comply with the new version.
3. As yodon said: Perform a gap analysis and identify the more stringent requirements for each test. Than test according these worst-case-conditions nad test levels. Eventually you will comply with both standard versions!
4. If there are conflicting requirements, apply your risk management process to identify the requirement which will lead to the lowest risk. Discuss those requirements with your notified body!

 

[SHunter]

Thanks Yodon and Benjamin, your answers are really helpful. I'll perform a gap analysis and apply our risk management process where needed.
After that, probably some discussions with our notified body is needed.