When is IEC 60601 required?

K

KatEspinoza

#1
Some background... We are a software company that intend to use off-the-shelf hardware. Our goal is to have a touchscreen tablet that is handheld. The device will be used to communicate basic needs from the patients native language to English, such as 'I want a blanket', 'I want some water', etc. Typically these devices would be deployed to a room when they receive a patient that does not speak English. I see that most hospital infotainment devices are 60601, but obviously cost a lot more than non-60601 devices. We also know that some facilities have patients complete satisfaction surveys on iPads which do not have 60601.

So... would our hardware need 60601? Does it matter if the device is only charged while outside the patients room? or can it be connected to a charger inside the room?

Thanks!
 
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Marcelo

Inactive Registered Visitor
#2
Re: When is 60601 required?

Hello, and welcome to the Cove

Standards such as IEC 60601 are only "required" if a regulation says so, and in most regulatory systems standards are optional - however, they are usually the best way to show conformance with the related regulatory requirements.

Now, to verify if IEC 60601 is applicable to your device - you need to check the definition of medical electrical equipment in IEC 60601-1.

MEDICAL ELECTRICAL EQUIPMENT
ME EQUIPMENT
electrical equipment having an APPLIED PART or transferring energy to or from the PATIENT or detecting such energy transfer to or from the PATIENT and which is:
a) provided with not more than one connection to a particular SUPPLY MAINS; and b) intended by its MANUFACTURER to be used:
1) in the diagnosis, treatment, or monitoring of a PATIENT; or
2) for compensation or alleviation of disease, injury or disability
Applied part is a part that necessarily touches the patient.

So, if the intended use of your device is to "communicate basic needs from the patients native language to English", it in principle (in my opinion) would not fall under the definition.

But please note that devices that transfer information are a little tricky, because it usually depends on the exact information transferred to be or not under IEC 60601.
 
K

KatEspinoza

#3
Re: When is 60601 required?

That's very informative!

However, if we were transferring information which classified the device as medical equipment, would a IEC 60601-certified power supply, coupled with an off-the-shelf hardware device, pass IEC 60601?
 
I

isoalchemist

#4
Re: When is 60601 required?

I'd look closely at the Mobile Medical Aps guidance and the MDDS. Based on what you have stated I don't think it qualifies as a Medical Device hence 60601 is moot from a regulatory perspective.

From a Marketing and Sales perspective approaching a hospital with 60601 certification may be a sales advantage, but at the cost..............
 
K

KatEspinoza

#5
We are also looking to sell our system as a Nurse Call System. What is the possibility of using an off-the-shelf consumer tablet, and getting it to pass 60601?
 
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