Is a 3V torch classified as medical electrical equipment needing EMI/EMC testing?

[kadambpa]

We have made a Class I (CE) metal medical instrument that has a plastic handle.

With use, doctors requested a light option to improve visibility and to free up the hand holding the torch.

We have incorporated a simple push switch and small light powered by standard 3V AAA batteries. The handle and minimal electronics built in has no contact with the patient

Since the light is not serving a critical risk, nor a voltage that is capable of causing harm. Can I show design files including the insulation and isolation provided and written justifications for safety without the formal EMI/EMC testing in a third party lab? Does simply adding a light with a swtich (no PCB, no AC source, no charging etc.) make this a medical electronic device?

 

[cdewitt]

Insulation and isolation are remedies for safety issues (IEC 60601-1) not EMC/EMI (IEC 60601-1-2). A simple battery operated light with no switching electronics will not have an EMC issue by itself but as I understand it this is an addition to an existing instrument and you need to consider this as part of the whole instrument. Sometimes a simple unrelated wiring change can affect your safety or EMC design.

 

[kadambpa]

Thank you for taking the time to respond.

My question was mainly around if just these components without a PCB or any active components would fall under "medical electronics" or "medical electrical equipment" since it has nothing to do with the core intended use of the device not is a critical part of it.

If it is indeed required. Could I satisfy requirements through documentation and calculation rather than actual testing?

Once again .

 

[Peter Selvey]

By the sounds of it, if it contacts the patient and is battery powered then it unfortunately it falls under IEC 60601-1, despite being an obviously very low risk situation.

There are around 1500 requirements in IEC 60601-1, but in practice ~99% of the standard will be not applicable, including things like EMC testing which can be argued as not applicable based on simplicity of the design.

There will be some small points like marking and issues around the battery. For example, requirements that cover things like marking the type of battery, polarity, checking what happens if the batteries are reversed or shorted make sense for this device.

Electrical safety can also be argued as being largely not relevant (although the standard is poorly written for 3V devices and can take some flexible thinking to navigate without ending up with 500Vdc tests).

The best approach might be to engage a local expert that can quickly write up a short report for IEC 60601-1 that extracts the small areas that are applicable, and writes up common sense justifications why the others are not.

If you try to approach a test lab, it ends up being very expensive and they may want to treat it too strictly e.g. insist on 500Vdc insulation, overly complex risk management, usability etc etc.

You can also try to do yourself, but it takes a little bit of experience to work through the standard, and knowing why things are applicable or not, hence engaging a low cost expert to write up say a 5 page simple report seems to be the best approach.