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Definition of ME Equipment/Applied part according to IEC 60601-1

K

Kh_Nadja

#1
Dear All,

Please help me to determine if our medical device falls under the definition of ME Equipment of IEC 60601-1.

We develop a pen injector which incorporates software (journal) for logging of the doses delivered by the patient (lay person). The device is battery-driven. The battery is rechargeable via a USB cable/USB charger or a personal computer. The patient/user holds the device with a hand when using it. Also, it cannot be entirely ruled out that a user may want to use it while charging (conected to supply mains).

As, getting back to ME equipment definition, I concluded that the device is not intended for transferring energy to of from the patient or detection of such energy transfer. Then, we need to determine if there is any applied part. Yes, it is in contact with the patient under normal use. But shall the device enclosure be defined as an applied part? There is some discussion in the standard about what to call an applied part, which, if I understood correctly, boils down to risk analysis answering the question if a patient, while holding it, might be struck with electric shock under normal or single fault condition.

Did I get it right? Does it mean that if our risk analysis shows that the risk when holding it is acceptable, then it is not an applied part and IEC 60601-1 is not applicable? Or shall we apply IEC 60601-1 anyway defining the enclosure as an applied part and then show that the risk is acceptable?

I would greatly appreciate your advise and comments! :thanx:
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#2
Nope.

The user/patient need to touch the device for it's intended use to be fulfilled. So that part is the applied part. Your device is a MEE.

The discussion on the standards you mention is related to parts which do not need to come into contact with the patient for the device to fulfill it's intended use but might come, so they would need to be treated as applied parts, even not being so.
 
K

Kh_Nadja

#3
Nope.

The user/patient need to touch the device for it's intended use to be fulfilled. So that part is the applied part. Your device is a MEE.

The discussion on the standards you mention is related to parts which do not need to come into contact with the patient for the device to fulfill it's intended use but might come, so they would need to be treated as applied parts, even not being so.
Hi Marcelo,
Thank you so much for the clarification!
 
#4
Hi All -

I have a similar question for my client's products. They manufacture stainless steel tubs that the user fills with water. The patient either sits in the tub (for the larger versions) or puts their hand or feet in them (for the smaller versions). There is a motor that spins an enclosed impeller that aerates and stirs the water. Physical therapists can use them for athletes to treat injuries or for after-practice therapy, or podiatrists can use the smaller versions for their patients. None of their products heat or cool the water - the water is supplied by the user's facility water source.

Does 60601-1 apply to these products? There is no applied part (the user does not need to touch any part of the tub or turbine for the intended use to be fulfilled). There is 'energy' supplied, but only mechanical energy (and very little at that) from the impeller.

I would argue that their products:
  1. Do not have an APPLIED PART since there is no part that must come into physical contact with the patient to perform its function. Even if the patient contacts the bottom or sides of the tub, the patient's contact is not required for the product to perform its function.
  2. Do not transfer energy to or from the patient - but it depends on how 'energy' is defined (which it isn't in the standard). The 60601-1 standard only references electrical energy and acoustic energy - not mechanical energy.
    1. Electrical energy? No electrical energy is transferred.
    2. Thermal energy? No thermal energy is transferred. Their products do not heat the water, so there is no thermal energy transfer from their product to the patient (only from the water to the patient, and the thermal energy does not come from their products but from the water supply).
    3. Mechanical energy? Does swirling water constitute mechanical energy? Does the word 'energy' in the definition of ME EQUIPMENT refer to mechanical energy as well? I don't know...
Thank you in advance!
Dave
 

Al Rosen

Staff member
Super Moderator
#5
I believe if the the patient or operator might come into contact with the part it's to be treated as an applied part. Look at 4.6 IEC 60601-1
 
#6
Hi Al -

Thanks for your feedback. My interpretation of 4.6 is that if the patient can touch a part that is not an applied part, the parts must meet the requirements for applied parts (except 7.2.10) - but that doesn't mean they are applied parts - they are parts that must meet the requirements for applied parts (if the risk management process determines this is the case).

Dave
 

yodon

Staff member
Super Moderator
#7
That's right, there's a distinction between applied and accessible parts and, as you note, if the risk assessment indicates, accessible parts may need to meet the same safety requirements as applied parts.

Regarding your question about mechanical energy, I think you'd be in a defensible position stating that stirring water doesn't transfer any energy to the patient.
 
#8
Looking for further interpretation: where a finished device has multiple sub-assys that house electronics & are not intended to supply heat where a sub-assy classified as an applied part - is it correct to interpret that different surfaces of that applied part can have different temperature specifications/requirements? My interpretation/understanding is that once a part (sub-assy) has been classified as applied, all surfaces of that part fall under that classification/set of requirements. I'd love to hear what you all think!
 
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