Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

​Hi,

If a laptop and  wireless mouse  is to be used with a medical device , does it need to be tested as part of the medical device testing . If  the manufacturer doesn't provide these items with the medical device and claims in the IFU on use of any laptop with the minimum requirements , is that acceptable?

It depends on the level of risk​. If you have evidence that it's designed to work with most any laptop meeting the minimum requirements, and nothing too serious is likely to happen if something goes wrong, it can be acceptable.

And yes, if a laptop and wireless mouse are somehow part of the intended use of a device, then validation and/or usability testing of the device will normally include a laptop and wireless mouse, unless you have some rational justification for omitting them.

------------------------------
Anne LeBlanc
Manager, Regulatory Affairs
United States
------------------------------

Original Message:
Sent: 21-Sep-2019 09:42
From: Anonymous Member
Subject: Laptops to be tested as medical devices

This message was posted by a user wishing to remain anonymous

​Hi,

If a laptop and  wireless mouse  is to be used with a medical device , does it need to be tested as part of the medical device testing . If  the manufacturer doesn't provide these items with the medical device and claims in the IFU on use of any laptop with the minimum requirements , is that acceptable?

I totally agree with Anne's comments about a laptop and wireless mouse MUST be part of your usability testing. I would also caution that there is a difference between the user interface of a MAC laptop and a Windows laptop from the user's perspective. Your user group(s) and setting will have a lot of impact. Hospital settings will probably be on Windows. Home users will have a higher percentage of MAC users.  You will want to validate that both operating systems work with your device and you should definitely think about testing with both configurations (again, depending on your user groups and setting).

------------------------------
Joely Gardner PhD
Usability Researcher and Professor
San Marcos CA
joely.gardner@humanfr.com
------------------------------

Original Message:
Sent: 21-Sep-2019 09:42
From: Anonymous Member
Subject: Laptops to be tested as medical devices

This message was posted by a user wishing to remain anonymous

​Hi,

If a laptop and  wireless mouse  is to be used with a medical device , does it need to be tested as part of the medical device testing . If  the manufacturer doesn't provide these items with the medical device and claims in the IFU on use of any laptop with the minimum requirements , is that acceptable?

Agree with Joely! If laptop is part of your medical device, i believe you will validate with the laptop in any case. As you mentioned, you have to clearly call out the specifications and requirements and list it clearly.

------------------------------
Loganathan Kumarasamy, MS RAC
Senior Consultant
Waukegan IL
United States
------------------------------

Original Message:
Sent: 24-Sep-2019 13:11
From: Joely Gardner
Subject: Laptops to be tested as medical devices

I totally agree with Anne's comments about a laptop and wireless mouse MUST be part of your usability testing. I would also caution that there is a difference between the user interface of a MAC laptop and a Windows laptop from the user's perspective. Your user group(s) and setting will have a lot of impact. Hospital settings will probably be on Windows. Home users will have a higher percentage of MAC users.  You will want to validate that both operating systems work with your device and you should definitely think about testing with both configurations (again, depending on your user groups and setting).

------------------------------
Joely Gardner PhD
Usability Researcher and Professor
San Marcos CA
joely.gardner@humanfr.com

Original Message:
Sent: 21-Sep-2019 09:42
From: Anonymous Member
Subject: Laptops to be tested as medical devices

This message was posted by a user wishing to remain anonymous

​Hi,

If a laptop and  wireless mouse  is to be used with a medical device , does it need to be tested as part of the medical device testing . If  the manufacturer doesn't provide these items with the medical device and claims in the IFU on use of any laptop with the minimum requirements , is that acceptable?

This message was posted by a user wishing to remain anonymous

​Hi,

Thanks all, for your feedback.. would there be any impact on the EMC testing with addition of a wireless mouse, would the testing need to be repeated ?
Original Message:
Sent: 24-Sep-2019 15:24
From: Loganathan Kumarasamy, MS RAC
Subject: Laptops to be tested as medical devices

Agree with Joely! If laptop is part of your medical device, i believe you will validate with the laptop in any case. As you mentioned, you have to clearly call out the specifications and requirements and list it clearly.

------------------------------
Loganathan Kumarasamy, MS RAC
Senior Consultant
Waukegan IL
United States

Original Message:
Sent: 24-Sep-2019 13:11
From: Joely Gardner
Subject: Laptops to be tested as medical devices

I totally agree with Anne's comments about a laptop and wireless mouse MUST be part of your usability testing. I would also caution that there is a difference between the user interface of a MAC laptop and a Windows laptop from the user's perspective. Your user group(s) and setting will have a lot of impact. Hospital settings will probably be on Windows. Home users will have a higher percentage of MAC users.  You will want to validate that both operating systems work with your device and you should definitely think about testing with both configurations (again, depending on your user groups and setting).

------------------------------
Joely Gardner PhD
Usability Researcher and Professor
San Marcos CA
joely.gardner@humanfr.com

Original Message:
Sent: 21-Sep-2019 09:42
From: Anonymous Member
Subject: Laptops to be tested as medical devices

This message was posted by a user wishing to remain anonymous

​Hi,

If a laptop and  wireless mouse  is to be used with a medical device , does it need to be tested as part of the medical device testing . If  the manufacturer doesn't provide these items with the medical device and claims in the IFU on use of any laptop with the minimum requirements , is that acceptable?

Also, depending on how the laptop and the mouse interface with the medical device but likely you will also need to consider IEC 60601-1, clause 16 requirements (Medical Electrical System Requirements).  You may want to refer to Annex I of IEC 60601-1 as it will show you different configurations that may apply and how to isolate properly.  Yes, Usability per IEC 60601-1-6 & 62366 (matching to 60601-1-6 but for FDA and many other regulators would be IEC 62366-1), you may have life cycle software to deal with as well under IEC 62304.  Lastly, you should also need to consider IEC 60601-1-2 (EMC).  Other standards may apply such as IEC 60601-1-11 for home use medical electrical devices and IEC 60601-1-12 emergency medical services medical electrical equipment and a whole host of Particular standards under the IEC 60601-2-XX or IEC/ISO 80601-2-XX.

So, you will likely have verification testing and validation testing involved in this type of design you have very briefly described.

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Original Message:
Sent: 21-Sep-2019 09:42
From: Anonymous Member
Subject: Laptops to be tested as medical devices

This message was posted by a user wishing to remain anonymous

​Hi,

If a laptop and  wireless mouse  is to be used with a medical device , does it need to be tested as part of the medical device testing . If  the manufacturer doesn't provide these items with the medical device and claims in the IFU on use of any laptop with the minimum requirements , is that acceptable?

This message was posted by a user wishing to remain anonymous

Hi Leonard,

Thanks for your feedback,

Does that mean each time we change the user interface with a different laptop , the Electrical safety , EMC , usability needs to be repeated. Currently we recommend the use of a laptop ( with the minimum requirements)  in the user manual and is not always provided as a standard accessory with the system.

Thanks,
Original Message:
Sent: 25-Sep-2019 02:41
From: Leonard Eisner
Subject: Laptops to be tested as medical devices

Also, depending on how the laptop and the mouse interface with the medical device but likely you will also need to consider IEC 60601-1, clause 16 requirements (Medical Electrical System Requirements).  You may want to refer to Annex I of IEC 60601-1 as it will show you different configurations that may apply and how to isolate properly.  Yes, Usability per IEC 60601-1-6 & 62366 (matching to 60601-1-6 but for FDA and many other regulators would be IEC 62366-1), you may have life cycle software to deal with as well under IEC 62304.  Lastly, you should also need to consider IEC 60601-1-2 (EMC).  Other standards may apply such as IEC 60601-1-11 for home use medical electrical devices and IEC 60601-1-12 emergency medical services medical electrical equipment and a whole host of Particular standards under the IEC 60601-2-XX or IEC/ISO 80601-2-XX.

So, you will likely have verification testing and validation testing involved in this type of design you have very briefly described.

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com

Original Message:
Sent: 21-Sep-2019 09:42
From: Anonymous Member
Subject: Laptops to be tested as medical devices

This message was posted by a user wishing to remain anonymous

​Hi,

If a laptop and  wireless mouse  is to be used with a medical device , does it need to be tested as part of the medical device testing . If  the manufacturer doesn't provide these items with the medical device and claims in the IFU on use of any laptop with the minimum requirements , is that acceptable?

One way to deal with this is to put the isolation on the I/O (input/output) ports of the medical device/system.  Then you may be able to have more flexibility instead of controlling the specific laptops and having the isolation on the laptop side by using isolation transformers.  You will at least have to state the laptops meet a minimum of IEC 609501-1 or the replacement standard IEC 62368-1 for ITE (Information Technology Equipment).
There are other options but would need to get into a lot more details.   Contact me for more information.

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Original Message:
Sent: 25-Sep-2019 19:33
From: Anonymous Member
Subject: Laptops to be tested as medical devices

This message was posted by a user wishing to remain anonymous

Hi Leonard,

Thanks for your feedback,

Does that mean each time we change the user interface with a different laptop , the Electrical safety , EMC , usability needs to be repeated. Currently we recommend the use of a laptop ( with the minimum requirements)  in the user manual and is not always provided as a standard accessory with the system.

Thanks,
Original Message:
Sent: 25-Sep-2019 02:41
From: Leonard Eisner
Subject: Laptops to be tested as medical devices

Also, depending on how the laptop and the mouse interface with the medical device but likely you will also need to consider IEC 60601-1, clause 16 requirements (Medical Electrical System Requirements).  You may want to refer to Annex I of IEC 60601-1 as it will show you different configurations that may apply and how to isolate properly.  Yes, Usability per IEC 60601-1-6 & 62366 (matching to 60601-1-6 but for FDA and many other regulators would be IEC 62366-1), you may have life cycle software to deal with as well under IEC 62304.  Lastly, you should also need to consider IEC 60601-1-2 (EMC).  Other standards may apply such as IEC 60601-1-11 for home use medical electrical devices and IEC 60601-1-12 emergency medical services medical electrical equipment and a whole host of Particular standards under the IEC 60601-2-XX or IEC/ISO 80601-2-XX.

So, you will likely have verification testing and validation testing involved in this type of design you have very briefly described.

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com

Original Message:
Sent: 21-Sep-2019 09:42
From: Anonymous Member
Subject: Laptops to be tested as medical devices

This message was posted by a user wishing to remain anonymous

​Hi,

If a laptop and  wireless mouse  is to be used with a medical device , does it need to be tested as part of the medical device testing . If  the manufacturer doesn't provide these items with the medical device and claims in the IFU on use of any laptop with the minimum requirements , is that acceptable?