Applicability of IEC 60601-1 to hyperbaric chambers

[kys123]

Hello everyone,

Recently I've been asking around if hyperbaric chambers are under the scope of IEC 60601-1 and I have been getting mixed answers from multiple consultants.

From my point of view, since they do not have applied parts or transfer energy to or from a patient, or detect such energy transference, they wouldn't be considered medical eletrical equipment and therefore would be outside the scope (I currently do not work with any ME equipment so I apologize if I am very wrong here).

Can someone help me figure this out? Why are so many "experts" confused about this?

 

[yodon]

I won't claim to be an 'expert' on this but it looks like hyperbaric chambers are Class 2 devices (FDA), product code CBF. Doesn't explicitly mention 60601-1 but I would be surprised if it wasn't.

 

[Enternationalist]

I mean, you're applying pressure to the entire patient's body. That counts as transferring energy in my books.

Also, a hyperbaric chamber will absolutely have at least one applied part. Understand that an applied part is anything that has to come into contact with the patient in order for the device to perform its function. To use a hyperbaric chamber, your patient needs to get into the chamber. That means they will be contact with (most likely) a platform or mattress inside the chamber. That's absolutely an applied part. If you need to be persuaded, see subclause 8.3 of the standard for examples of patient tables being considered an applied part.

Also, there's a spirit of interpretation here. It's electrical equipment that you put a patient into in order to deliver a medical therapy. Of course 60601-1 should be applied. Even if it could be argued that it is not technically in the scope (which it definitely is), I'd consider it negligent not to apply the same standards.

 

[kys123]

I mean, you're applying pressure to the entire patient's body. That counts as transferring energy in my books.

Also, a hyperbaric chamber will absolutely have at least one applied part. Understand that an applied part is anything that has to come into contact with the patient in order for the device to perform its function. To use a hyperbaric chamber, your patient needs to get into the chamber. That means they will be contact with (most likely) a platform or mattress inside the chamber. That's absolutely an applied part. If you need to be persuaded, see subclause 8.3 of the standard for examples of patient tables being considered an applied part.

Also, there's a spirit of interpretation here. It's electrical equipment that you put a patient into in order to deliver a medical therapy. Of course 60601-1 should be applied. Even if it could be argued that it is not technically in the scope (which it definitely is), I'd consider it negligent not to apply the same standards.

Thank you so much for your answer. I can now agree that it is applicable, and with some good information to back me up too when I go talk to my consultants later.

I just wasn't able to find the example you mentioned on 8.3 regarding patient tables.

 

[Enternationalist]

Apologies, a typo - Subclause 3.8.

 

[Peter Selvey]

Great analysis by Enternationalist.

Side point: I've worked with a lot of manufacturers and routinely find their consultants are way out of their depth when it comes to standards. I suspect the reason is they are good at structure e.g. 510(k) application or CE marking technical file, but not the technical details for each device, which of course makes sense if you think about the huge variety of medical devices. While that is reasonable, the complaint is they pretend to know and give out wrong advice, such as in this case.