IEC 60601-1-2 EMC TESTING

[Ohad Barsheshet]

Hey People i need some help,

My Medical device is about to go under testing soon, I want to make sure I'm ready and make some test myself on the subject, but couldn't find any information about what testing needs to get done and what parameters I should follow, can someone hit me up with some information or a source of information for that matter?

Thanks in advance,

Ohad.

 

[mr9000]

There are not many in-house (pre-)tests you can perform without having access to (calibrated) test equipment or in case of rf emissions a big EMC compliant chamber. And the test equipment is expensive.
Fastest (and cheapest) way is to book some time with a certified test lab for some pre-testing. If you're not 100% sure what you need to test, just ask them, they have seen hundreds of medical devices and know what to test. Just be aware that you are the last instance to decide whether to test something or not later in the "real" certification tests.
The two biggest factors are rf emissions, which require a chamber (I wouldn't hassle with free field measurements if you are not a certified lab and know what you do), and ESD safety. Maybe you can get your hands on a ESD pistol, but watch out for the correct measurement (where is the GND connection, how and where to connect the coupling planes and bleeding resistors). For that, just get a copy of 61000-4-2 and study it.

For EMC and ESD compliant hardware design there are tons of application notes from various manufactureres, such as

https://www.infineon.com/dgdl/Infineon-AP2402635_General_PCB-AN-v03_05-EN.pdf?fileId=5546d46261ff5777016229f8523036f1

https://www.ti.com/lit/sg/sszb130d/sszb130d.pdf?ts=1693916667638&ref_url=https%253A%252F%252Fwww.ti.com%252Fproduct%252FTPD4S012

For emissions you could get a cheap HackRF and misuse it as a spectrum analyzer

Using the HackRF One as a wideband spectrum analyzer – 0xStubs

0xstubs.org

It at least can give you an idea what components are prone for emissions or where the origin of certain frequencies are.

 

[Ohad Barsheshet]

Hey! thank you very much for your input!
We will book a lab soon but i want to have an idea of what to look for (Major Emissions) that i can handle and control before i go there and waste both our time and money
i have a spectrum analyzer and i will look into that ESD Pistol ill forward the information given to my expert on the subject, thanks!

 

[yodon]

With all the test labs we work with, you can rent the lab space for a 1/2 day or full day and they will facilitate any tests you want to run before doing it for score. That gives you a real good idea of where you stand since you're using the same equipment that will be used in formal testing.

 

[FelipeSchneider]

I hope I still have time to help...
The book Electromagnetic Compatibility Engineering by Henry Ott provide good test methods and tips to troubleshoot eventual problems.
Skip the first chapters and go straight to the application section.

 

[emceng]

Ken Wyatt has some great books on doing testing outside an accredited lab

https://www.amazon.com/stores/Kenneth-Wyatt/author/B00SNQ1LJ2

There's a ton of good info in them to build your own setup for pre-compliance.