Rationale for 60601-1-2 Accompanying Documents Requirements

[Mark Meer]

I'm wondering if anyone can explain a rationale for the requirements in IEC 60601-1-2 (5.2.1) to have to include the detailed EMC tables in accompanying documentation.

These tables are large, and highly technical, and can take up several pages...

In my opinion, the only valuable information (as far as end-users are concerned) is the "Electromagnetic Environment Guidance" columns, and separation distance guidances.

All the other information belongs in test reports (not product accompanying documents).
For example, why the heck would an end-user need the formulas to calculate RF separation distance, when the recommended distances are already given??

Am I totally off-base in thinking this is an example of IEC requirements going too far? Can anyone enlighten me as to what the rationale (value) is in requiring these highly technical tables?

 

[Pads38]

I believe that the idea behind the inclusion of the tables was to provide guidance when planning complex environments such as multi-bay Intensive Therapy Units.

In such an environment you would expect dozens of devices all to be used in close proximity so that formal EM "budgets" are planned to try and get everything working together.

But, I agree, the tables are daft. It takes me long enough to work out what information they provide - and I write them! For all but a very few specialist engineers / planners they merely create confusion.

I have not yet got a copy of the new version of 60601-1-2 (2014, Ed 4) but I think I have seen draft versions that have removed the requirements for the tables, or at least have limited the need to "high risk" devices.

One further thought - the tables are shown as being part of the "Technical Description" (rather than the "Instructions for Use"). As such, they might be provided separately (say a CD-ROM) to avoid cluttering up your IfU. (Risk management required).

 

[Mark Meer]

...I think I have seen draft versions that have removed the requirements for the tables, or at least have limited the need to "high risk" devices.

This would make MUCH more sense. The details of the current tables really provide value in only a small subset of all electrical medical devices (as you say, complex setups/environments, high-risk...).

Sweeping prescriptive labelling requirements whose value really only applies to certain situations is a pet-peeve of mine, as I really do think it has the potential to backfire.

For example, we are developing a device for home-use (lay-person use). Precautions referring to IEC 60601, or even just using the terms "separation distance", "immunity", "emissions" and "electromagnetic compatibility" are sure to cause more confusion than aid to end-users.

One further thought - the tables are shown as being part of the "Technical Description" (rather than the "Instructions for Use"). As such, they might be provided separately (say a CD-ROM) to avoid cluttering up your IfU.

I've considered this, but still have 2 objections:
1. It's yet another document and BOM item to control.
2. It's still required to have a precaution referring to the technical documentation. So when a lay user reads the IFU and sees a precaution that says (to paraphrase) "special setup is required to be safe, refer to technical manual", and then the referenced technical manual has a bunch of highly technical details, you really haven't eliminated the confusion.