EN 60601 - Use of Laptops, Computers, PCs placed in a Patient Environment

E

Eggsn

#1
I understand that per EN 60601, a computer/laptop/PC if placed in a patient environment has to meet the standard as it is considered now a medical device.

My confusion here is what about those laptops that have the cleared/approved software in them that manufacturers give out and is placed near the operting room (OR) for use? How are manufacturers able to get clearance or approval from a system that uses a laptop to operate the procedure or imaging system? Are there other standards I am missing as well?

Any help will be appreciated. Thank you.
 
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sreenu927

Quite Involved in Discussions
#3
Generally, laptops and PCs won't be an accessory of the Medical device. Only the SW will be a part of the device. If IVD, an IVD symbol will be placed on SW CD or on the SW user manual. Verification of this device SW on particular Operating Systems will be performed and documented.

When u submit for registration, you submit the system with the SW, not with the particular laptop or PC. You hv provide information on the available configuration, for eg., this medical device system is supplier along with the Laptop as option 1 and PC as Option 2. Customers can select their choice of configuration.

When SW or OS is changed, then it will affect the performance of the device, but not the change of laptop or desktop.

Rgds,
Sreenu
 

Peter Selvey

Staff member
Super Moderator
#4
Under the 2nd edition (IEC 60601-1:1988, or EN 60601-1:1990), items like PCs are handled under IEC 60601-1-1 (systems standard).

In principle, the components of the "system" should meet the appropriate standards (e.g. IEC 60601-1 for the medical device that contacts the patient, IEC 60950 for a PC that may connect to the medical device), and the leakage currents of the whole system should stay below the EN 60601-1 limits. The leakage current part can be met by a number of strategies, e.g. isolation transformers, earth bonding, use of low leakage laptop, isolated signal connections etc.

There are a couple of other considerations, for example, check connectors are not dangerously compatible, e.g. an medical ECG that uses a D15 plug that can also be accidentally plugged directly in the back of the PC would be dangerous.

For the 3rd edition (IEC 60601-1:2005, EN 60601-1:2006), the principles are the same, but the requirements have been incorporated into Clause 16 of the standard.

As the other poster have mentioned, the software in the PC can be a medical device, if the software is specifically written for the medical purpose. Other software on the PC (e.g. operating system, MS office etc) is not a medical device even if used for a medical purpose, since the "manufacturer" of that software did not intend it for a medical purpose.
 
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