Is IEC 60601 applicable to our smart bed?

[CPolley]

Hello Elsmar,

We are developing smart beds for children with Autism and other special needs. We have determined based on similar products that we're a Class 1 510K exempt product. We're trying to determine what standards are applicable to our bed and specifically if IEC 60601 is.

Our beds have calming sensory inputs (lights, speakers, vibration) as well as a camera for remote monitoring by parents/caregivers. These are the only electrical components. In the future, we may have actuating lifts to raise the head/feet but not yet. All electrical devices are previously UL certified as standalone products.

I understand that the definition of 60601 is:

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

We aren't transferring energy to or from the patient or detecting energy.

I am unsure if we qualify as having "applied parts". Sub-clause 3.8 states that an APPLIED PART is “part of ME EQUIPMENT that in NORMAL USE necessarily comes into physical contact with the PATIENT for ME EQUIPMENT or an ME SYSTEM to perform its function.

Patients within the bed do not necessarily need to come into contact with the electronics for them to function. They could touch the face of the camera/light though. Currently, we do provide the option for the patient to click buttons on the light/speaker to turn them on/off but we could restrict access to this or specify in instructions that only parents/caregivers, not the patient, would be the ones that should access these.

Any help is appreciated.

Thank you,
Caleb

 

[ECHO]

Without knowing more about your design, device description and intended use, it will be hard to say what standards will apply to you device.
However, below are a few that you might want to review.

IEC 60601-1-6
IEC 60606-1-8
IEC 60601-1-11
IEC 60601-2-49
IEC 60601-2-52
IEC 62304

Also, isn't light, sound and vibration different forms of energy?

 

[AbelVV]

Vibration is definitely energy. There's a clause about it in 60601 (IEC 60601-1 9.6), but that doesn't necessarily make it fit in there. A hand held drill is not under 60601, for example.

The real question is if 1 or 2 are met.

1) in the diagnosis, treatment, or monitoring of a PATIENT; or
2) for compensation or alleviation of disease, injury or disability

Also the use of bedsheets doesn't mean that there is no physical contact between the bed and the "patient", in my opinion. Imagine all the kinds of shenanigans you could pull off doing that.

 

[Marcelo]

If it's a bed and a patient lies on it, and it's electrical, it has an applied part and IEC 60601 is applicable.

 

[AbelVV]

If it's a bed and a patient leis on it, and it's electrical, it has an applied part and IEC 60602 is applicable.

But 1) and 2) is what make the distinction "patient" vs regular user. If I have a massaging bed at home it is not a medical device. In this case, does the fact that the intended user has autism preclude that they are a patient?

 

[Marcelo]

But 1) and 2) is what make the distinction "patient" vs regular user. If I have a massaging bed at home it is not a medical device. In this case, does the fact that the intended user has autism preclude that they are a patient?

The OP does mention that it's a patient, so this distinction does not seem to make a difference here.