IEC 60601-1 and 60601-1-2 - Not Applicable for My Medical Device

[rcjpedro]

Hi All!

Does any of you kind sirs possess a checklist or template were I could technically and in detail justify that 60601-1 and 60601-1-2 are not applicable to one device?

The mains basis for NA of the device would be:

As per 60601 Definitions:

3 * Terminology and definitions
For the purposes of this document, the following terms and definitions apply.
(…)
3.63
* MEDICAL ELECTRICAL EQUIPMENT
ME EQUIPMENT
electrical equipment having an APPLIED PART or
transferring energy to or from the PATIENT or
detecting such energy transfer to or from the PATIENT
and which is:
a) provided with not more than one connection to a particular SUPPLY MAINS; and
b) intended by its MANUFACTURER to be used:
1) in the diagnosis, treatment, or monitoring of a PATIENT; or
2) for compensation or alleviation of disease, injury or disability

My Device:

does not have “an APPLIED PART” and
does not “transfers energy to or from the PATIENT or detects such energy transfer to or from the PATIENT”

Of course all is consistent with Classification Rule and Clinical Evaluation and TF.

Thank you in advance

 

[Mark Meer]

Very curious:

Your device is electrical, and intended for medical purposes, but doesn't contact the patient, nor detect or transfer energy?

What does it do?

 

[Marcelo]

It can be an IVD or any other laboratory equipment (which are "usually" not medical electrical equipment under 60601).

 

[yodon]

It can be an IVD or any other laboratory equipment (which are not medical electrical equipment under 60601).

But in which case would fall under IEC 61010, right?

 

[rcjpedro]

Hi Mark,

Its classified as per

RULE 11
All active devices intended to administer and/or remove medicines, body liquids
or other substances to or from the body are in Class IIa,

Thanks for your interest

 

[rcjpedro]

Hi Marcelo and yodon,

It is a Medical Device it has already been on the market but had to be withdrawn because I couldn't produce enough evidence for not falling under the scope of 60601

Thanks for your interest

 

[Marcelo]

But in which case would fall under IEC 61010, right?

If it fit under the scope of IEC 61010, yes.

 

[Marcelo]

Hi Marcelo and yodon,

It is a Medical Device it has already been on the market but had to be withdrawn because I couldn't produce enough evidence for not falling under the scope of 60601

Thanks for your interest

It's really difficult to help if you don't say what the device is, including it's intended use.

 

[Ronen E]

It can be an IVD or any other laboratory equipment (which are not medical electrical equipment under 60601).

I tend to agree with you, however I once worked on an active device that could be classified as an IVD (at least one of its variants) and had an argument with the development team - I argued that it was exempt from 60601 based on "no applied part" etc. and they argued that it had an applied part because otherwise the user wasn't able to handle it. The device was non-rechargeable battery powered, and via a rather convoluted arrangement was electrically in touch with a mains transformer/charger that could, in some rare situations, be part of the set-up. The charger wasn't part of the medical device, nor an accessory to it.

 

[Marcelo]

I tend to agree with you, however I once worked on an active device that could be classified as an IVD (at least one of its variants) and had an argument with the development team - I argued that it was exempt from 60601 based on "no applied part" etc. and they argued that it had an applied part because otherwise the user wasn't able to handle it. The device was non-rechargeable battery powered, and via a rather convoluted arrangement was electrically in touch with a mains transformer/charger that could, in some rare situations, be part of the set-up. The charger wasn't part of the medical device, nor an accessory to it.

Well, I tried to make a general remark only. In fact there's IVDs that can be medical electrical equipment depending on the intended use (one common example are insulin strip analyzers, if the device requires that you cut your finger in a strip not attached to the device, it's not a medical electrical equipment. If the strip needs to be attached to the device, it's a medical electrical equipment).