Medical device with NON medical PC - USB galvanic insulation

A

AmirBaron

#1
Hi All,
Could any one please explain me why a medical device electrical safety standard is so strict than a standard electrical device?
For example:
A medical device with IEC60601-1 can't be connected to standard PC VIA USB without a proper galvanic insulation.
But any mobile phone can be connected to a PC directly VIA USB.
The user is exposed to the same safety hazards. So why it's less important to protect the user when using non medical devices.

Thanks
 
Elsmar Forum Sponsor
T

temujin

#2
Hi,

There are several reasons for this.

Although the patient is exposed to the same hazards as the user of any electrical equipment the risk of the hazard turning into harm is much greater.
This is due to the following:
  • If you are exposed to electrical current you will feel it, and automatically try to let go of the current carrying object. The patient, for some reason or other (illness, sedatives) will not be able to respond to this the same way as a healthy person.
  • Much less current could be necessary to harm a patient that a healthy person, due to the patients generally weaker condition.The patient might also be open during a heart surgery, be connected to electrodes, other monitoring systems.

I´m sure others can complete the list.
regards
t.
 
M

MIREGMGR

#3
The specific ethical basis for heightened concern toward harm of patients by medical equipment comes from Primum non nocere, Latin for "First, do no harm"...which is taught to all medical students.

The specific legal basis comes from the partial responsibility of health care entities (hospitals, etc.) and physicians for patient welfare under legal liability theories.
 
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