Electrical Safety standard for medical device not covered by IEC 60601

G

Giorgia

#1
#1
Dear All,

I'd like to clarify with you the applicability of 60601 to this medical device:
it is a syringes filling equipment which is battery operated.
It has been designed in order to help the user (operator/patient) to automatically fill a syringe (50ml).

In my opinion this is not covered by the standard IEC 60601-1 because it
  • doesn't have applied parts
  • doesn't transfer energy to/from patient
It is used to fill the syringe by placing it on the device and switching on the power button.

So for these reasons I think it is not in the scope of IEC 60601-1
Do you agree?

The situation could be different if during its use the patient should hold it but this is not the case.

So I'm wondering which is the standard to be used in order to ensure the electrical safety of this device

Thank you in advance to anyone who can help me
Regards!
G.
 
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M

Marcelo

Inactive Registered Visitor
#2
#2
Giorgia said:
Dear All,

I'd like to clarify with you the applicability of 60601 to this medical device:
it is a syringes filling equipment which is battery operated.
It has been designed in order to help the user (operator/patient) to automatically fill a syringe (50ml).

In my opinion this is not covered by the standard IEC 60601-1 because it
  • doesn't have applied parts
  • doesn't transfer energy to/from patient
It is used to fill the syringe by placing it on the device and switching on the power button.

So for these reasons I think it is not in the scope of IEC 60601-1
Do you agree?

The situation could be different if during its use the patient should hold it but this is not the case.

So I'm wondering which is the standard to be used in order to ensure the electrical safety of this device

Thank you in advance to anyone who can help me
Regards!
G.
Click to expand...
Hello, and welcome to the Cove!

IEC 60601 is applicable to medical electrical equipment (which is a type of medical device).

For IEC 60601 to apply, the device must fit into the definition of medical electrical equipment under IEC 60601, which is:

electrical equipment having an APPLIED PART or transferring energy to or from the PATIENT or detecting such energy transfer to or from the PATIENT and which is:
a) provided with not more than one connection to a particular SUPPLY MAINS; and b) intended by its MANUFACTURER to be used:
1) in the diagnosis, treatment, or monitoring of a PATIENT; or
2) for compensation or alleviation of disease, injury or disability
Click to expand...
If the intended use of the device in questions is "help the user (operator/patient) to automatically fill a syringe (50ml)", it does not fit the intended use described.

So it would not be a medical electrical equipment.

Now, the device would still need to meet electrical safety requirements, and there's two possibilities:

- apply specific requirements from IEC 60601, probably adapting some requirements

- apply a standard such as IEC 61010 (this seems like the better option, as the device would probably fir under the scope of this standard).
 
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