Identifying APPLIED PART of Medical device use in HOME HEALTHCARE ENVIRONMENT

[Zang Lee]

According to cl.3.8 of IEC 60601-1, the definition of 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”

An internally powered auto-injector, which allowed patients to operate by themselves, for example in the below photo, has an injection tip (orange color part) that will contact injected skin tissue. And that tip is considered as APPLIED PART undoubtedly. If we stick to the literal content of cl.3.8, the handheld part (white color part) of the auto-injector, which came into physical contact with the PATIENT(=OPERATOR), will also fall into the definition of APPLIED PART.

Then, the manufacturer want to apply IEC 60601-1-11 cl.8.5.3 second paragraph "However, parts which the PATIENT intentionally handles as the intended OPERATOR according to 7.9.2.1 of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 + IEC 60601-1:2005/AMD2:2020 (e.g. touch keys, ENCLOSURE) while the ME EQUIPMENT is not being used for its intended medical function may be insulated with two MOOP from SUPPLY MAINS." And the manufacturer want to treat the handheld part (white color part) as ACCESSIBLE PART, instead of APPLIED PART. And treat it as MOOP protected ACCESSILBE PART.

My question is the following phrase "while the ME EQUIPMENT is not being used for its intended medical function." Is the clause support to treat handheld part (white color part) as MOOP protected ACCESSILBE PART, while the duration the patient is injecting him/herself?

 

[Zang Lee]

My question should continually discuss here below, follow the exstiing post, called: "Identifying Applied Parts" posted on Sep 4, 2020.

 

[william guo]

You can refer to ISO 11608-4 for isolation requirement, which is a special way....

 

[Souheil]

I don't understand why there need to be 2MOPP @240V between 2 and 4 for Type X NIS-E ! This is overkill !

 

[Zang Lee]

You can refer to ISO 11608-4 for isolation requirement, which is a special way.... View attachment 29659

Thank you for introduce ISO 11608-4 for this discussion, I think this ISO standard will play an important role when we discuss injector. I am reading it right now.

 

[Zang Lee]

I don't understand why there need to be 2MOPP @240V between 2 and 4 for Type X NIS-E ! This is overkill !

I believe that @240Vac is considered under condition of MAINS on APPLIED PART (AKA reverse leakage current), or it is overkill.

 

[Enternationalist]

I don't see how the manufacturer's rationale could hold up here. They literally need to be touching it while they're injecting themselves. That's the intended use.

The hazard here is electrical, presumably the potential of a pathway from the injection site in a loop around the body back through the device handle. Seems like an obvious safety case to have two MOPP.

I hope also considered is the actual injection needle, since that will pierce the skin - the very fact that this happens, greatly increasing the potential for harm to the patient in the event of an electrical hazardous situation, is just the type of event I imagine the writers would have had in mind when they made that clause apply only when the device isn't being used.