Are laptops part of ME SYSTEMS? Reading of IEC 60601-1

[Medevice]

There are medical devices on the market that require the use of a connected laptop that the operator touches in order to perform their function, but they do not have a laptop supplied with them, only the software to run on the laptop.

My reading of IEC 60601-1 regarding ME SYSTEMS and PATIENT ENVIRONMENT indicates to me that any laptop used would most likely be in the PATIENT ENVIRONMENT and therefore subject to the testing required for the ME EQUIPMENT.

If I am correct, how is it that a device manufacturer can claim that any laptop can be used with the medical device when it is being used on a patient?

What have I missed?

 

[Medevice]

Re: Are laptops part of ME SYSTEMS? Reading of 60601-1

The answer is:

They cannot. For a laptop, or any kind of PC, to be used with a medical device it must either be a medical device itself, or be located outside of the PATIENT ENVIROINMENT. The instructions for use must require the latter if it is not a medical device.

 

[Marcelo]

Re: Are laptops part of ME SYSTEMS? Reading of 60601-1

The problem here is that a system should be TESTED together so it can´t be ANY computer mas a SPECIFIED one. Also, it can be inside the patient environment, but the system has to conform to the requirements of the system standard (or to the new IEC 60601-1 which incorporates the system standard).