Could IEC 60950 Compliant Adaptor be used in Home Healthcare Environment?

Hello all,

We are going to develop a home use equipment. Since the operator is also the patient, I am wondering if 60950 adaptor can be used?

The equipment is for aesthetic use. The operators/patients are not weak at all because of they have healthy skin and consciousness, etc. From this point of view, I would think it is sufficient to design such equipment to meet MOOP. This said 60950 adaptor can be accepted. Can I have your opinion please?

Thanks and regards,
Roland

A Quick Bump!

Can someone help Roland?

Thank you very much!!

Stijloor.

In my opinion, in the case where the patient is the operator, the higher requirements of MOPP must be used.

It may be possible to use a 60950 PSU if, say, it was used as a battery charger and the unit couldn't be (medically) used whilst charging.

I think this is the confusing situation which the standard do not clarify clearly.For home healthcare equipments, the patients is always the operatior. Based on requipment of IEC 60601-1, the PSU should be designed to MOPP.
But, for commom situation, profiles of many operators of home healtcare equipent (such as massage equipment,therapeutic equipment) are similar as those of operatior of IT,household equipment etc.
MOPP is too stringent for such situation. The rational way to handle this stituation,I think, is using risk management.The manufacturers identify the intended user/operator of such equipmen and outline their profile/condition(such physical condition, mental condition and conscious condition etc).
Base on the profile, we can determine which MOP (MOOP or MOPP) should the PSU be desinged to.

Although MOPP uses the word "patient", it seems from Clause 4.6 that the intention of the writers was that MOPP only applies to the "applied part".

So we can at least narrow the discussion to the applied part rather than the whole equipment enclosure.

That may help for some home use devices.

For example, if a sensor part is Type BF and has 1.5kVrms isolation, then this combined with a 950 power supply should be enough for MOPP.

For other parts which the patient may touch, MOOP (950) in principle is OK, subject to Clause 4.6.

There are still some parts like a keypad which the patient must touch but for which MOPP is overkill. In this case RM could be used to modify the standard to allow MOOP based on the nature of contact.

However, be wary, that kind of RM justification might be a red flag for test agencies and regulatory reviewers.