Has anybody any experience of gaining certification for portable electrical (battery powered) medical devices for (in) aircraft use – specifically UK/EU? The device in question complies with EN 60601-1, EN 60601-1-2 (Electromagnetic Compatibility), ISO 10079-1 and BS EN 1789.
I’ve come across another EMC test wrt airworthiness i.e. RTCA/DO-160 (section 21) and also a form from the CAA (AD 70) which refers to getting a “Declaration of Design and Performance (Number)” from an approved authority (who?). There is also a CAA airworthiness leaflet (AIL/0176) which references lots of other regulations. So it is the practical method (s) somebody out there has used that I am interested in.
:thanx:

Can anyone help Steve with his request?

Any takers ?

Steve, I'm sorry, but I just don't know if there is anyone here with this specialized knowledge.

Kind of a fundamental question, but have you tried contacting the FAA or even the airlines? I would think they could help send you down the correct path.

Again, sorry I can't help.:(

Because I was curious, I sent an inquiry on this to the FAA on the 31st. They've acknowledged receiving the inquiry, but have not yet responded substantively.

Thanks for trying guys! As a first step I have managed to get some quotes for EMC testing (based on DO-160F) - not cheap! Obviously a specialist area as indicated. Also found a standard - BS EN 13718-1:2008 covering the subject. I will look into contacting the appropriate authorities (CAA in the UK I think) as suggested. It will be interesting to see what comes from the FAA. It may be that the emphasis might well be on the user to assess suitability of a medical device in an 'extreme' environment - like the military do.

:thanx:

Sorry if this isn't timely anymore, but I heard back from the FAA.

The question I asked was: What is the procedure for a manufacturer to obtain an airworthiness certificate for an item of electronics equipment (with a medical intended use) to be used aboard a commercial or private aircraft?

Unfortunately, they passed the buck...but at least they referred me to a specifically relevant procedure. They said: Your local FAA Aircraft Certification Office (ACO) can give the best answer to your question. Their personnel will evaluate your question along with any specific issues you may have. You can find contact information for your local ACO on our website at:
http://www.faa.gov/aircraft/air_cert/locate_office/aco/
Thank you for your question.

***

This FAA document appears to describe the process for approval of avionics and related equipment, which might include medical electronic devices: http://www.faa.gov/aircraft/air_cert/design_approvals/media/CPI_guide_II.pdf

Thanks for the info, MIREGMGR :agree: