60601 compliance (medical device electrical standard)

Hi,

I am looking for examples of companies that have incorporated Arduino boards into medical applications. Has anyone used Arduino boards as components in devices that have passed 60601 related testing?

Our application is for a diagnostic device that is non-patient contacting and battery powered (running at 9 or 12 volts).

Any references / direction to people that have successfully navigated this space is deeply appreciated!

Bill

(deleted)

Yup, not without express written consent:

SAFETY-CRITICAL, MILITARY, AND AUTOMOTIVE APPLICATIONS DISCLAIMER: Atmel products are not designed 
for and will not be used in connection with any applications where the failure of such products 
would reasonably be expected to result in significant personal injury or death (“Safety-Critical 
Applications”) without an Atmel officer's specific written consent. Safety-Critical Applications 
include, without limitation, life support devices and systems, equipment or systems for the 
operation of nuclear facilities and weapons systems. Atmel products are not designed nor intended 
for use in military or aerospace applications or environments unless specifically designated by 
Atmel as military-grade. Atmel products are not designed nor intended for use in automotive 
applications unless specifically designated by Atmel as automotive-grade.

They do respond to requests, use the Support link at www.atmel.com

I've contacted them for technical questions and re-publishing of diagrams in a book myself, but not for medical use approval. Your application might be fine, hard to tell from your vague description,

But assuming the atmel piece did get signed off, what about the Arduino containing it?

If you get Atmel approval, then I'd go for a custom design from there so you can control it the other parts being used. Minimize the parts, minimize the approval process.

I suspect most of us don't know what "60601 related testing" is or who results are submitted to for approval, but I suspect simpler with secure connections is better. Maybe an Uno or Mega with Screw shield would suffice? Don't know without more info. Maybe a Promini from a qualified/certified distributor who can supply traceability back to the manufacturer, that you solder wires to for connectivity, would be sufficient.

Thank you for the replies and suggestions. I plan to reach out to Atmel. The application involves evaluating the response (in a chemistry based system) to a drop of blood added to the system. Additional feedback is welcome!

60601 is broadly referenced in the medical device industry. The US FDA recognizes it as a consensus standard -(edition IEC 60601-1-2), and they look for a device to pass testing before they will let you sell it. There is a lot more on the web if you are interested in the subject.

Bill

So that sounds more like a chemical/biological system with software controlling it. I think Arduino would be fine unless it got to the point where medical procedures were to be applied back on a patient.