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Related Topic Tags
class ii medical device, emc (electromagnetic compatibility), iec 60601 - medical electrical equipment, iec 60950 (information technology equipment - safety), label symbols, labels and labeling (general), medical devices (general)
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  #1  
Old 17th May 2012, 08:00 PM
Roland chung Roland chung is offline
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Please Help! Class II Medical Device Marking - Different IEC 60950 & IEC 60601 Requirements

Hello forums,

In IEC 60601-1, Class II equipment with functional earth (e.g. internal screen for EMC purpose) should also mark a Class II symbol on the label.
However, the same construction is forbidden to mark with Class II symbol in IEC 60950 (see clause 2.6.2 for details).

Would it be a problem when such a 60950 compliant equipment became an item of ME system?

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Roland
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Old 18th May 2012, 03:12 AM
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Re: Class II Medical Device Marking - Different IEC 60950 & IEC 60601 Requirements

A Quick Bump!

Can someone help?

Thank you very much!!
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Old 18th May 2012, 05:38 AM
ca_moni ca_moni is offline
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Re: Class II Medical Device Marking - Different IEC 60950 & IEC 60601 Requirements

Our notified body , many years ago, refused to accept a label with the class II mark and we had to remove it.
The device was class II, but it was powered by a commercial (medical grade) power adapter on which the connection to earth was used for the EMC screen. The output of the power adapter was a two-pole concentric connector, so no way that there were a protective earthing of the device: nevertheless, they stated (in brief): "If there are three pins in the mains plug, then it is a class I".

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Old 18th May 2012, 10:33 AM
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Re: Class II Medical Device Marking - Different IEC 60950 & IEC 60601 Requirements

Thank you for sharing experience.

It seems IEC 60601-1 is clear to the classification of equipment with functional earth. It is reasonable to classify such equipment to Class II, because of the equipment does not rely on basic insulation plus protective earthing for protection against electric shock.
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Old 20th May 2012, 08:18 PM
Peter Selvey Peter Selvey is offline
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Re: Class II Medical Device Marking - Different IEC 60950 & IEC 60601 Requirements

ca_moni mentioned:

Quote:
The device was class II, but it was powered by a commercial (medical grade) power adapter on which the connection to earth was used for the EMC screen.
I would be suspicious in this case. In 25 years I have seen a couple of cases of Class II equipment with a functional earth, which is then confirmed to have 4kV/8mm spacing from mains parts as required in IEC 60601-1. But these had custom designed power supplies, not off the shelf. I never saw an off the shelf Class II "Medical grade" power supply with a functional earth. I expect it not to be commercially viable because the application is rare, and the potential for confusion is also high.

For the original question, I think it is not an issue in terms of compatibility with IEC 60601-1.

A device labelled as Class I (i.e. no double box symbol) but has all internal earth connections double insulated from mains parts (8mm/4kV) and only used for functional purpose still complies with IEC 60601-1. While unusual, there is no point of non-compliance in the standard, and no safety issues.

Also, this is the best option. The potential confusion from labelling a 3 pin device as Class II is not worth it. If the earth is used only for EMC, then it still needs to be connected to earth anyway to comply with regulations. The user does not know the internal construction so it makes no difference to them if the internal earthing is functional or protective.
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Old 21st May 2012, 10:52 PM
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Re: Class II Medical Device Marking - Different IEC 60950 & IEC 60601 Requirements

Thank you for your opinion.

We actually have an equipment with functional earth only. The equipment is enclosed by plastic. Yes, it is indeed a 3 pins device. But the earth conductor in the power supply cord is directly connected to the interior coated surface which made for EMC purposes.

If such equipment is classified as Class I, it really conflicts with the definition and clause 8.6.9.
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Old 21st May 2012, 11:16 PM
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Re: Class II Medical Device Marking - Different IEC 60950 & IEC 60601 Requirements

Clause 8.6.9 would be not applicable if the equipment is classified as Class I. So, it's not a problem.

The only I see would be the definition:
Quote:
3.95 PROTECTIVE EARTH TERMINAL
terminal connected to conductive parts of CLASS I equipment for safety purposes. This terminal is intended to be connected to an external protective earthing system by a PROTECTIVE EARTH CONDUCTOR
Some people might say if there is no safety related connections then the terminal cannot be called a protective earth terminal. But even the metal parts of the terminal itself (e.g. the end of an appliance inlet that extends inside the equipment, or the terminal block for connecting the cord) should be considered an internal connection.

Also, looking at the definitions and requirements in the standard, in particular figure 4, it may be that a functional earth terminal is different to the pin in the appliance inlet or terminal for L/N/E cord connection. So the NB's original comment may be correct (3 pin device must be Class I).
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Old 22nd May 2012, 04:28 AM
Roland chung Roland chung is offline
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Re: Class II Medical Device Marking - Different IEC 60950 & IEC 60601 Requirements

So, you meant the protective earth connection in my case is only from the pin of plug to pin of appliance inlet, the functional earth connection is from pin of appliance inlet to interior coated surface.

So, the 25A/0.1 ohm test can be performed, but only between the pin of plug and pin of appliance inlet.

If it is ture, the concept of Class II equipment with functional earth (clause 8.6.9) becomes superfluous.
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