IEC 60601-1 and IEC 60601-2-2

#1
I am working on a medical device that falls under the scope of IEC 60601-1.
The device comes close to be under the scope of IEC 60601-2-2, but technically, the device does not meet the definition of an HF SURGICAL EQUIPMENT as defined in IEC 60601-2-2.

So, in that aspect, the device would technically not be under scope of IEC 60601-2-2, and we would not need to assess our device against IEC 60601-2-2.

But, IEC 60601-2-2 has some amendments / additions that are relevant to our device.

Has anyone been in a similar situation (not necessary the same particular standard)? If so, how did you decide whether to:

1. Claim compliance to the particular standard and rationalize why certain clauses in the particular standard are not applicable.

or

2. Do not claim compliance to the particular standard and as part of main standard, rationalize how/why certain clauses can be assessed per the particular standard.

It seems like #1 and #2 above are the only choices, but open to knowing if there might be another option to consider.
 
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Benjamin Weber

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#2
Why should an amendment be applicable, but the standard not??? The amendment cannot be applicable alone.
What do you mean with "addition" to the standard?

Either 60601-2-2 is applicable or it's not. Nothing in between. That's the bureaucratic perspective. But due general requirement to take account of technology and practice existing at the time of design (as it stated for example in MDD), you might conclude that requirements of a standard are aaplicable, even though your device does not officially fall under the scope of that standard. And a notified body might also push you towards application of a particular standard.

How did you find, that certain requirements of the particular standard are applicable?

Maybe you identified hazardous situations during the risk management, were the risk control measure related to compliance with certain requirements of the particular standard. This might be a good rationale, why only selected requirements are applicable, rather than the whole standard.
 

Pads38

Trusted Information Resource
#3
I would suggest that you could exclude the particular standard stating that your device is not in the scope of the standard.

And then say that select clauses have been used as 'design inputs' or, as Benjamin W says, have been used to inform your risk management process.
 

Peter Selvey

Staff member
Moderator
#4
This situation is fairly common, where a medical device does not fall under the scope but there are at least some requirements in the standard that would make sense for the device, or make sense after being modified/adapted for the particular device.

As already mentioned, it is important not to declare compliance with the standard, even though some third parties such as notified bodies suggest it.

Good practice is to then go through the standard clause by clause and then make an assessment if the requirement should be :
- applied in full
- applied in a modified way (test and/or criteria)
- not applied (not appropriate for the device)

A record of this review is recommended to be retained along with notes justifying the decisions, which can be brief especially if it is obvious. This record can help when dealing with third parties, but also useful internally for design change and understanding.

This review should then be used to create a new specification. That specification should be given a reference number (logistically it makes sense to keep this separate) which is then linked from the main system design specification, and then the usual design process followed, ensuring these specifications verified and validated as normal.

You could also back fill the risk management to fit but I think that does not provide any real value unless the issue was something that would normally be raised in risk management.

A good example is a device that uses electrodes on the back to pick up µV levels for specialised diagnosis and has a front end very similar to ECG, but is not actually ECG. The ECG standards (-2-25, -2-27, -2-47) could raise a lot of reasonable issues like common mode rejection ratio (CMRR), but obviously many other aspects are also irrelevant. To follow this example, it might be decided that CMRR is adopted as a specification with modified tighter criteria owing to the very small voltages being measured.

The thing is, CMRR is not the normal kind of subject that comes up out of risk management, it's more of a run of the mill design issue. You could massage it into risk management but that would be inconsistent since there are thousands of similar design issues. So it makes sense to just stay as a design spec. However, there could be issues normally raised in risk management (such as the need critical protection systems) where the "new specification" (based on the standard) could address. So of course in this case, the risk management file can point to the item in the new specification that acts as the risk control measure. But I would not do this systematically for every specification that comes out of the above process.
 
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