Are Defibrillator Protection and Pacemaker pulse detection features mandatory as per IEC 60601-2-25 or 2-27...?

subbash

Involved In Discussions
#1
Dear All,

If we are planning to apply for FDA 510(k). Is it mandatory to have a Defibrillator protection and Pacemaker pulse detection.

Both these tests are part of IEC 60601-2-25 and -2-27

Request you to provide your inputs.
 
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yodon

Staff member
Super Moderator
#3
Not enough information to determine; you don't say what your device is.

Two recommendations: 1) get a regulatory consultant to determine submission requirements; 2) talk to a test lab (e.g., Intertek <-- example only; I'm not endorsing) and get their take.
 

subbash

Involved In Discussions
#5
Not enough information to determine; you don't say what your device is.

Two recommendations: 1) get a regulatory consultant to determine submission requirements; 2) talk to a test lab (e.g., Intertek <-- example only; I'm not endorsing) and get their take.
Hi Yodon,

Thanks for the reply.

We are working on a diagnostic ECG device. Which can take 12 lead ecg and provide measurements. We don't have a Defibrillator protection feature implemented on our ECG device.
Our ecg device is only intended to be used in clinicians office and not intended to be used in Operation theatre or ICU.
Can we just address this by a statement in the instruction manual and also on device labelling....?

Hence, I wanted to understand if Defibrillator protection and Pacemaker pulse display capability are mandatory features as per IEC60601-2-25 and IEC 60601-2-27 standard requirement.....?
 

yodon

Staff member
Super Moderator
#6
That helps! I went out to the FDA site for device classifications and found: Product Classification

You can see the list of consensus standards there. Both the standards above are, indeed on the list, so unless there are exclusions, I would think you would have to meet (all) the requirements. Again, a chat with a test lab might be your best bet for options.
 

subbash

Involved In Discussions
#8
What is the risk if your ECG is connected to a patient who has an implanted pacemaker/defibrillator and it energizes?
Hi Rosen,

If we use a device that has not defibrillation protection. Then it will lead to device damage and also affect patient.
Using a device which does not detect pacemaker pulse can lead to error while interpretation and measurements.
 
#9
As you indicate -2-27 (ECG monitoring equipment) demands defibrillation protection.
And, with the proliferation of automatic AED it may not be possible to justify not having protection if just used in a clinic.

But look closely at the 'Scope' of -2-27. It describes the expected use and environment of use and specifically excludes some devices (eg ECG telemetry). So, it might be a better idea to exclude all of -2-27. Perhaps a better choice of 'Particular' standard would be -2-51 (recording and analysing ECG).
I don't have a copy so do not know of it's handling of defibrillation protection.
 

Al Rosen

Staff member
Super Moderator
#10
As you indicate -2-27 (ECG monitoring equipment) demands defibrillation protection.
And, with the proliferation of automatic AED it may not be possible to justify not having protection if just used in a clinic.

But look closely at the 'Scope' of -2-27. It describes the expected use and environment of use and specifically excludes some devices (eg ECG telemetry). So, it might be a better idea to exclude all of -2-27. Perhaps a better choice of 'Particular' standard would be -2-51 (recording and analysing ECG).
I don't have a copy so do not know of it's handling of defibrillation protection.
Research reveals that IEC60601-2-51 has been withdrawn and replaced with IEC60601-2-25.
 
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