Room requirements for electrical tests in devices

[Rjr90]

Hi, I follow the forum a some time ago learning, first, thank you all.
But I can't find and dont know if there is right place.
I work for a company which manufactures some medical devices and now we'll have our first eletrical device (the truth is, we'll resell), anyway, we'll need to assure the maintenance of the devices, but we haven't anything related to eletrical devices on our company now, its all new world for us.
My question, do we need to follow any regulamention normative to have a room to do just working tests on our new devices? Not for certification, just check the functions, and measure current, frequency, etc.
It's a ultrasonic generator, if it helps.
I'm afraid if we just buy a wooden table and plug it on power, we can broke some rule and affect our ISO certification, because i couldn't find nothing related.

Thank you very much in advance.

 

[renenatasha]

Welcome to the Cove, Rj!

For the start, I'm not from an electrical medical device company but I do enjoy reading.

You may want to have a look at the IEC 60601 series HERE which are applicable to medical electrical equipment.

Here's another link just for reading pleasure:
Know Your Regulations Before You Design Medical Electronics | Electronic Design

All the best in your quest - Rene

 

[yodon]

There are a few points to consider.

First, you are concerned about your ISO certification. Does the scope of your certification cover what you're doing with the equipment?

Second, exactly what are you doing? You mention 'maintenance' which would require that you collect data to demonstrate the devices meet specification after the maintenance work. Under 13485, this would fall into several sections in 7.5.

To collect data that can be used for regulatory purposes (e.g., to demonstrate the product meets specification), you'll need to use suitable equipment (i.e., calibrated, appropriate, controlled). Under 13485, this would be addressed in section 8.

You probably have new infrastructure and work environment requirements (see section 6) and, of course, anyone performing any task assigned must be competent to do so (also section 6).

In general, there are few sections (other than 7) which WOULDN'T apply as you take on new responsibilities.