IEC 60601-1-4 - Required for Data Management System that just collects Data

S

Silvertabb

Is this standard required for data management system that just collect data from devices via wireless or usb connection? This data management software will be installed on a PC.
 

Marcelo

Inactive Registered Visitor
Required or applicable? It would be required if applicable and called by a regulation.


Regarding applicability, It depends on whether your system provides no basic safety/essential performance or poses no risk. If so, the requirements for PESS would not be applicable as defined in IEC 60601-1 or IEC 60601-1 third edition.

This is not very clear on IEC 60601-1-4, but it´s clear on IEC 60601-1 third edition (60601-1-4 was incorporated into third edition).

Anyway, even if IEC 60601-1-4 or IEC 60601-1 3 ed are not applicable, IEC 62304 would still be applicable (class A medical device software).
 
S

Silvertabb

Thanks Mammatunes,
What is IEC 62304 about and why is it applicable?
 

Peter Selvey

Leader
Super Moderator
From a strict interpretation point of view, IEC 60601-1-4 is not applicable to a medical device (including stand alone software) unless it meets the definition of "medical electrical equipment" in IEC 60601-1, in other words electrical equipment with a medical purpose and direct contact or energy exchange with the patient.

I would expect that a data management system does not fit this definition so IEC 60601-1-4 would not be applicable.

As mmantunes mentioned, for Europe at least, IEC 62304 is applicable for software (incorporated or stand alone) if the intended purpose fits with the definition of a medical device.
 
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