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Class II type machine , and its compliance with 60601-1

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P

Peter Selvey

Staff member
Super Moderator
#12
#12
Class I, Class II were original intended just for mains, with Class III intended for devices powered by an unspecified, non-mains external supply at low voltages which are already safe, i.e. from a separate power supply that has it's own safety insulation which could be Class I or Class II.

For example, your mp3 player is a Class III device that can be charged from any 5V USB. If the USB supply itself has a mains part, it can be assumed to be safe based on regulations that normally apply to any mains connected power supply. That supply could be Class I (e.g. desktop PC) or Class II (small wall plug in device). Hence it is not meaningful to refer to the mp3 player as either Class I or Class II.

IEC 60601-1 mangled this as it so often does. They argued that Class III is not acceptable for medical devices, which is OK (mostly), but it should have created a new Class e.g. Class IIIS = powered by a specified separate supply.

Instead they just deleted Class III, which left it unclear as to whether secondary powered devices should be Class I or Class II.

In practice this is irrelevant. All the clauses in the standard that mention Class I or Class II are only relevant to mains parts. Sometimes this is not immediately clear and you need to check the definitions, or titles or preliminary comments. For example, in Clause 7.2.6 there is a requirement that Class II devices are marked with the double box symbol. However, the clause title is "Connection to the SUPPLY MAINS". 8.11.5 (fuses in the supply) similarly has a reference to "mains" in the clause title.

At it's core, "protective earth" itself is defined as a connection to the "external protective earthing system" (i.e. the wall supply). Class I and Class II are intended to indicate if this connection is important for safety.
 
M

muhammad sadiq

Registered
#13
#13
Peter Selvey said:
Instead they just deleted Class III, which left it unclear as to whether secondary powered devices should be Class I or Class II.
Click to expand...
but Sir then come the same ques that I asked before that if my ME which I take as a Class II device , is not directly connected to the mains but through a 24V class II medical grade power supply (IEC 60601-1 complaint/2 MOPP), then do I need to put double insulation between 24v,12V,5V lines (voltages that our circuitry works on) and enclosure ?
 
M

muhammad sadiq

Registered
#14
#14
Peter Selvey said:
IEC 60601-1 mangled this as it so often does. They argued that Class III is not acceptable for medical devices, which is OK (mostly), but it should have created a new Class e.g. Class IIIS = powered by a specified separate supply.
Click to expand...
Benjamin Weber said:
If your device needs a metal enclosure, but you cannot use a PE (e.g. due to IEC 60601-1-11 for home healthcare devices which explicetly allows only class II or internally powered!)
Click to expand...
when does this change came do you have an idea , we here have home choice APD , liberty APD both are for home health care system , but both are CLASS I , which goes against 60601-1-11 , but they are old, they have this on their back "grounding reliability can only be achieved when the equipment is connected to an earth ground receptacle"
 

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P

Peter Selvey

Staff member
Super Moderator
#15
#15
The insulation between 24V/12V/5V is not related to Class I or Class II.

Normally 24V or less would be safe for home use devices, like a blood pressure meter or a thermometer, since the patient is at no special risk, and people can normally access 5V, 12V, 24V parts in the home environment.

However, peritoneal dialysis is a good example of a situation where special care is needed. Conductive fluid passes through the machine where there may be heaters, sensors, valves, and then goes to the patient where the fluid has very low impedance contact in the body. Also it is in contact for long periods of time. That makes it extremely high risk for electric shock. It is one area where 2 MOPP is really important even for 5V (and this will apply whether Class I, Class II or a separate power supply).

With good design it's not that difficult to make sure the fluid path is suitably isolated from everything. But for peritoneal dialysis it's best to get a qualified expert involved to look at your particular design. It's not something that can be reviewed in forum like this.
 
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