Medical Device that is class II electrical and IEC 60601-1-11

JoCam

Trusted Information Resource
#1
Hi All,

Standard IEC 60601-1-11 states that medical electrical equipment used in the home care environment, if it is not permanently installed, will need to be a class II electrical device. Does this mean that a class I electrical device can no longer be called medical electrical equipment if it is to be used in a home?

As 60601-1-11 is not mandatory, if a manufacturer of a class I electrical device chooses not to test their product to it, do they need to test it to something else to enable it to be used in the home?

In my opinion, if this standard states that the medical electrical equipment for use in the home cannot be class I electrical, surely the standard should be mandatory or this requirement appear in something that is?

Your help as ever will be much appreciated.

Jo
 
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isolytical

Involved In Discussions
#2
The change actually works out in favor of the manufacturer, not against them. The change to class II status allows use of the equipment with two-prong, double insulated AC inputs, rather than relying on earth ground for protection. The reason for the change is that many homes do not have reliable earth ground.
While a redesign is obviously needed. it should not be a major concern to a EE. And the requirement actually widens the market for the manufacturer, and it applies to non-permanently installed devices.
 

3dBUnderThe Limit

Starting to get Involved
#3
I do think that the requirements in 60601-1-11 limits unnecessarily what the manufacturer can do to enable safe use in the home from electrical safety standpoint, but I’m not aware of any alternative standards to use to show compliance to MDD/MDR for an ME for home use. Home use does in my opinion need to fulfill both 60601-1-11 and the relevant test criteria’s in 60601-1-2.
Changing to Class II AC input is reasonably straight forward, but you will need an applied part that is floating to avoid fixed installation. Leaving out protective earth will also make the production and testing simpler both in manufacturing and the field.
ME equipment for home does in my opinion need to fulfill both -1-11 and the relevant test criterias in -1-2.

Changing to Class II AC input is reasonably stright forward, but you will need an applied part that is floating to avoid fixed installation. Leaving out protective earth will also make the production and testing simpler both in manufacturing and the field.
 

Pads38

Trusted Information Resource
#4
Hi Jo,

As you say, the use of a standard (any standard) is always voluntary but I am not sure that a Notified Body would accept a home healthcare device without the use of -1-11. It, effectively, defines the home as a 'special environment'.

But, if you are looking to class your device as something other than a medical device you would need to make sure that you had no claims of a medical purpose.

Safety standards for 'general purpose' household products include the IEC 60335 series of which there are over 100 standards covering everything from kettles and irons to washing machines etc.

Another option would be IEC 62368 covering audio visual, IT and communications equipment, and also 60950 and 60065.

Each of these standards are harmonised under the Low Voltage Device Directive. There will also be EMC standards applicable, but I don't have the numbers to hand.

Incidentally, various IEC committees are looking at outstanding safety issues not covered by the introduction of 60601-1 edition 3 and 3.1 (and the various collaterals). They are looking to better define 'permanently installed' as some manufacturers have been installing by plugging in then screwing a strap across the plug to prevent dis-connection. The committees do not regard this as adequate.

They are also looking to see if industrial style plug and sockets, such as the EN60309 series might allow high-integrity earth connections to be assumed whilst offering some degree of transportability.
 
#5
JoCam,

Which market is -1-11 not mandatory? Our product was required to be compliant in the USA, Canada and EU for several years now. Same for -1-12, at least in the US for another product used in ambulances.

B_S
 

dgrainger

Trusted Information Resource
#6
Bryce_S,
In Europe, all standards are voluntary, manufacturers can use them to show compliance with essential requirements.
Harmonized standards infer compliance with those essential requirements indicated in the standard.
 
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