Question on whether IEC 60601-2-62 standard is applied

[KSDavid]

Hello everyone.

I'm medical device test engineer. one of my customer asked me whether IEC 60601-2-62 is applied to skin lifting device.

In the scope of the IEC 60601-2-62, this standard is applied to therapeutic high intensity ultrasound equipment.

Since skin lifting device is not therapeutic equipment but beauty equipment, I'm not sure but I think there is no need to apply IEC 60601-2-62.

I would like to have some advise on this. Thank you.

 

[Ronen E]

Is "skin lifting" effected through applying high intensity ultrasound?

 

[Benjamin Weber]

As Ronen E already asked: What is the physical effect to achieve the skin lifting?

Second question: Is this a medical device? I guess not really, since it is only for cosmetic reasons. If we are talking about the european market, the MDR is applicable. There is Annex XVI, were some device types are explicitely listed, which do not fall under the definition of a medical device but whoch are also in the scope of the MDR. As far as I can see, a skin lifting device that uses ultrasound is not covered here. But this strongly depends on the physical effect! Annex XVI lists for example:

Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.

Maybe this applies to the device?

If not: Which regulation or directive should be followed? Sometime cosmetic device manufacturers apply the low-voltage directive hoping they might completely forget about the 60601 series. But the problem is, that you have to apply the current state of art according to all regulations/directives I know. And performing some kind of risk management might find that you have to apply of course the relevant harmonized standards of the directive/regulation, but also relevant standards that are beyond the harmonized standards. This might lead to applying 60601 for non medical devices.

So, if the device really uses high intensity ultrasound, I think IEC 60601-2-62 should be applied. I don't have the complete standard, so I am not really sure how "hight intensity therapeutic ultrasound" is defined, maybe this could clarify if the standard is applicbale?

But be aware, that there are also exclusions in the scope:

This particular standard does not apply to:
• ULTRASOUND EQUIPMENT intended to be used for physiotherapy (use: IEC 60601-2-5 [1]2)
and IEC 61689);
• ULTRASOUND EQUIPMENT intended to be used for lithotripsy (use: IEC 60601-2-36 [2]);
• ULTRASOUND EQUIPMENT intended to be used for dedicated hyperthermia devices;
• ULTRASOUND EQUIPMENT intended to be used for phacoemulsification.

Maybe one of these applies to the device?

 

[Ronen E]

A few of comments:

1. Not all regulatory jurisdictions require/expect that the state of the are is kept up with (it's mostly an EU thing). There are pre-amendments (pre-1976!) devices perfectly-legally in distribution, with no FDA expectation of manufacturers to update them or their original clearance.

2. Under no circumstances anyone "has to" apply any harmonized standards as such.

 

[Souheil]

Annex A of the standard IEC 60601-2-62 sates:
Definition 201.3.218 HIGH INTENSITY THERAPEUTIC ULTRASOUND (HITU) EQUIPMENT
HIGH INTENSITY THERAPEUTIC ULTRASOUND (HITU) is a precise medical procedure using high
levels of ultrasound intensity (e.g. Ispta > 100 Wcm-2) or ultrasound pressures (e.g. p-> 3 MPa
but this is frequency dependent) to destroy or disrupt tissue or non-tissue elements (for
example liquids, bubbles, micro-capsules).

I doubt that the device is able to produce such levels of intensity or pressures. Therefore, I don't believe that the -2-62 is the right standard to apply.
I would rather take a look the standards -2-5 or -2-37 to check the levels of Mechanical Index, Thermal Indices (-2-37), Beam non linearity ratio (-2-5) and the requirements for the transducer heating (both standards).