IEC 60601-1-11 - Home Care Device Minimal requirements

Dr RA

Involved In Discussions
#1
will remote of ME require extensive EP as homecare device? If yes, what are the minimal requirements. If no, what are the rationale?

Many thanks

RA
 

yodon

Staff member
Super Moderator
#2
Maybe it's just me but I'm a bit unclear on your post. First off, are the acronyms ME for Medical Electrical (Equipment) and EP for Essential Performance?

When you say "remote" are you implying control or monitoring? And who is performing actions remotely?

I would need much more information about your device and what it does before being able to answer.
 
#3
Does the standard apply? (I presume it is intended for home use, correct?)

Do you have a copy of the standard?

If so, the requirements should be apparent. Do you have any specific requirements from IEC 60601-1-11 that you are uncertain about? If so, as yodon says, more details about the product would be necessary to weigh in...
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#4
Please note that the title of the standard is "home healthcare environment" as

HOME HEALTHCARE ENVIRONMENT
dwelling place in which a PATIENT lives or other places where PATIENTS are present, excluding professional healthcare facility environments where OPERATORS with medical training are continually available when PATIENTS are present
EXAMPLES In a car, bus, train, boat or plane, in a wheelchair or walking outdoors.

Note 1 to entry: Professional healthcare facilities include hospitals, physician offices, freestanding surgical centres, dental offices, freestanding birthing centres, limited care facilities, first aid rooms or rescue rooms, multiple treatment facilities and emergency medical services.
Basically, it's any place that is not a professional healthcare facility environment. So it's not really "homecare"only.
 

Top Bottom