Classification of Medical Device with Partial Compliance with a particular standard

A

aeropel

#1
Hi,

I have an ECG recording device (low cost) that does not comply with the particular standard 601-2-25. Bandwidth is lower, sampling rate is lower etc. How shall I classify it? it? Can I only apply the 601-1-1 with no particulars? It is for home use.

Thanks
 
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M

MIREGMGR

#2
Re: Partial compliance with particular standard

One conforms to a performance standard as a means of achieving/demonstrating conformance to a medical device regulatory system's requirements for your device type. In USA, you might be conforming to the performance standard so as to meet the expectations to file for and obtain a 510(k) premarket clearance. In Europe, you might be demonstrating conformance to the Essential Requirements.

Particularly under the MDD, there are three basic conformance paths: conformance to a Harmonized Standard, conformance to some other recognized standard, and a non-standard-based approach. The former approach requires the least evidence and explanation to the Notified Body or other reviewer, the latter approach the most evidence and explanation.

If you're only partly complying to a standard, you're following the third path.

FDA utilizes a similar approach, though not as clearly defined. To obtain a 510(k), you have to convince the examiner that your device is safe and effective. If your standards compliance is partial, you'll have more explaining to do.
 

Peter Selvey

Staff member
Super Moderator
#3
Re: Classification of Medical Device with Partial Compliance with a particular standa

In this case it would be advisable to comply with all of the standard except for specific points (e.g. frequency response). Then you only have the job of explaining the rationale behind those points only. Also, although you may not meet the full bandwidth, you still need to meet a bandwidth as justified by your application.

If you provide:
- a complete report, showing the non-conformity(s)
- the alternate specifications (e.g. revised bandwidth)
- verification report for the alternate specifications
- justification for the alternate specifications (expected is a clinical discussion why a reduced bandwidth is reasonable, for example, limit to adult population, target for particular disease etc)

Then it is complete and complies with the regulations. An auditor would have to provide objective evidence the justification is not valid, which is unlikely if the justification is properly documented.

If you don't apply the whole standard, it's unlikely to be accepted. There are many other ECG tests besides bandwidth like CMRR, noise, sensitivity accuracy etc etc which are likely to be reasonable to apply. Again, there may be justification for revised specifications for a home use device, but most of these tests are still reasonable.
 

Roland chung

Trusted Information Resource
#4
Re: Classification of Medical Device with Partial Compliance with a particular standa

Hello Peter,

Based on this topic, I would like to ask a question related to particulars of 3rd edition.

IEC 60601-2-25:2011 now includes the contents of the IEC 60601-2-51:2003. For ECG function, as part of patient monitors or defibrillators, which particulars should be applied? IEC 60601-2-25:2011 or IEC 60601-2-27:2011?
 

Peter Selvey

Staff member
Super Moderator
#5
Re: Classification of Medical Device with Partial Compliance with a particular standa

The scope of IEC 60601-2-25:2011 now clearly states that "cardiac monitors covered by IEC 60601-2-27 [are excluded] where not intended for obtaining ECG REPORTS for diagnostic purposes".

Previously, IEC 60601-2-51 did apply to a patient monitor if there was an arrhythmia interpretation function, which many patient monitors had (e.g. to trigger alarms).

However in the new edition (IEC 60601-2-25, which replaces IEC 60601-2-51), the interpretation section is removed. I don't know why, maybe they plan a separate standard. So without that there is not much justification to apply to a patient monitor which is intended primarily to detect the heart rate.

There are a couple of catches: first is many monitors include a "diagnostic" filter with 0.05Hz ~ 150Hz. If this is included, this could be a reasonable justification for applying IEC 60601-2-25.

Also, some patient monitors include a function to monitor the ST segment. Again, this could trigger the application of IEC 60601-2-25.

The good news is, if there are no automated measurements made and displayed (e.g. QRS amplitudes, durations) then it is really similar to IEC 60601-2-27, just with tighter limits (e.g. 5% for sensitivity, instead of 20%). And that's quite reasonable as well - a limit of 5% makes much more sense than 20% if diagnostic decisions are being made based on the ECG record, and 5% is easily achievable with modern technology.
 

Roland chung

Trusted Information Resource
#6
Re: Classification of Medical Device with Partial Compliance with a particular standa

Thank you, Peter.

Do you sum up significant changes between 1st edition and 2rd edition of IEC 60601-2-25?
 
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