EN 60601-1 - Cable requirement low voltage DC - Medical weigh scale

qu1nn

Involved In Discussions
#1
Hello, relatively new to 60601-1 with regards to making use of AC power supply. Please bear with me while I fumble through this question:

The device is classified as medical weigh scale. The scale is separated into 2 components:
1) Display Fixture that is embedded into the wall
2) Weighing platform Frame consisting of load cells that is embedded into the floor

There are no motors, or heating devices.



The device has a UL purchased power supply which drops it to 12Vdc which is used to power the load cells, display electronics, and printer.

I am questioning the cable that goes from the display fixture to the weighing platform frame which is contained within conduit. The voltage in the wire is less than 12V and the current is less than 12mA. The cable is a circular DIN style connector on each end.

What type of insulation voltage rating is required to meet the EN 60601-1 specification?


Thank you for your time

Qu1nn
 
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T

temujin

#2
Re: 60601-1: Cable requirement low voltage DC

Hi and welcome to the Cove,

The question you need to ask is if the cable can be classified as an Accessible Part, i.e. will it come into contact (unintentionally) with the patient? (..which I believe it will).

THere is a table in 60601-1 with isolation thicknesses for different voltages, though I do not remember where. (I do not have the standard any more).

Another thing you might need to look up is the flammability class of the isolation.

If you already have a Notified Body, they will be able to help you out.

regards
t.
 

qu1nn

Involved In Discussions
#3
Re: 60601-1: Cable requirement low voltage DC

Thank you for your response, it is appreciated.

according to the definitions contained within EN60601-1:2006

Accessible Part (3.2)
"part of electrical equipment other than an APPLIED PART that can be touched by means of the standard test finger"

This would really not apply as the cable in question is behind the wall at the display, in the conduit to the scale, and under the scale platform. The cable would not be even visible unless the platform was removed... So I don't think that it would be considered Accessible (the only time it would be accessible is during the initial installation of the product... that is unless that counts??)

I would think that the part would more closely match the definition of SIGNAL INPUT/OUTPUT PART (3.115) - "part of ME EQUIPMENT, not being an APPLIED PART, intended to deliver or receive signals to or from other electrical equipment, for example, for display, recording or data processing."

where the APPLIED PART (3.8) - "part of ME EQUIPMENT that in NORMAL use necessarily comes into physical contact with the PATIENT for ME EQUIPMENT of an ME SYSTEM to perform its function."

Do you agree that the APPLIED PART in this case would be the platform that the user stands on in order to take a weight measurement?


I have some more to look up right now.
Thanks again, look towards more comments.

qu1nn
 
T

temujin

#4
Re: 60601-1: Cable requirement low voltage DC

Hi again,
This would really not apply as the cable in question is behind the wall at the display, in the conduit to the scale, and under the scale platform. The cable would not be even visible unless the platform was removed... So I don't think that it would be considered Accessible
If the cable is hidden in the wall it is definitely not an Accessible Part.

I would think that the part would more closely match the definition of SIGNAL INPUT/OUTPUT PART (3.115) - "part of ME EQUIPMENT, not being an APPLIED PART, intended to deliver or receive signals to or from other electrical equipment, for example, for display, recording or data processing."

I don´t think you need to classify it as SIP/SOP if it is only within your own equipment. It is not defined as an external interface for other displays to connect to (as far as I understood). That apart, SIP/SOP would be the interface, not the cable itself.

Do you agree that the APPLIED PART in this case would be the platform that the user stands on in order to take a weight measurement?
Yes.


As for the cable, I don´t think this belong in any particular category...it´s just an integral part of your equipment. Though, take a look at the requirements for flammability / fire safety in 60601-1 - I think those will be the most important ones for such a cable.

regards
t.
 

qu1nn

Involved In Discussions
#5
Stumbled on another item that I am confusing myself on:

would you agree that the definition of PATIENT CONNECTION does NOT apply as there is no physical wires (making an individual point) that are getting attached to the patient:

or

that it DOES matter because in a single fault condition a current could flow between the platform and the patient? (single point being entire platform)

I am leaning towards the latter.


PATIENT CONNECTION
(3.78)
"individual point on the APPLIED PART through which current can flow between the PATIENT and the ME EQUIPMENT in NORMAL CONDITION or SINGLE FAULT CONDITION."



Thank you for your time
Qu1nn
 
R

royal77

#6
Hi,
The patient connection need not be exactly wires. Any conductive part will act as a patient connection. for example, the X-ray table on which a patient lies is also a applied part. I think, you should provide two levels of patient protection for the highest voltage available at that applied part.
 
T

temujin

#7
Hi again,

that it DOES matter because in a single fault condition a current could flow between the platform and the patient? (single point being entire platform)
I would rather make sure current cannot flow in single fault condition by applying more means of protection, as pointed out by royal77.

regards
t.
 
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