Applicability of Defibrillator Energy Test to Implantable Devices

[elars]

Hello everyone,

First post here. I tried searching previous posts on this topic but did not find one.

Does anyone know if the 60601 defibrillator energy test is applicable to implantable devices such as pacemakers, ICDs, or LVADs?

I've inspected pacemakers and have not been able to identify the series resistors that would be required to pass this test. My thought is the lead vectors are confined to small distances or are orthogonal to the current field, inherently limiting the amount of shunted current in vivo. Without these resistors a device would fail this test. Is there an exception for implanted devices?

Thanks,

Erik

 

[Stijloor]

A Quick Bump!

Can someone help Erik?

Thank you very much!!

 

[Pads38]

You would probably be better of using the implant standards. In particular there is EN45502 - Active implantable medical devices.

Clause 20 of that standard is titled "Protection of the devcie from damage cause by external defibrillators"

45502-1 is the "general" standard with 45502-2-x being a series of particular standards covering different types (pacemakers, nerve stimulators, ICD etc). For pacemakers (45502-2-1) the test of the "general" standard applies. I don't, now, have that standard so can't help much there, even though I have actually performed the test (some time ago!).

There is another (ISO?) series of implant specific standards but, having been out of the implants business for some time now I can't help there either!

And welcome to the forum!

 

[elars]

Thanks for the info! I'll definitely look into these standards.

Erik

 

[Pads38]

Hi Erik,

I notice now that you are in Texas. EN45502 is a European standard so you may be better looking for an AAMI or international equivalent standard. A quick look on the AAMI web site shows up:

ANSI/AAMI PC69:2007 -- Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators

ISO 14708-1:2000 -- Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

ISO 14708-2:2012 -- Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers