Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi,

We have a system that is cleared for navigation in the OR.  The system contains software that can be installed on a computer with pre-defined minimal requirements.
The company is seeking to make a change and provide the user with an off the shelf tablet as an optional accessory, on which the software will be installed. The user will not be in direct contact with the tablet and the patient at the same time. The tablet may be placed within 0.5m from the patient's bed.
The  off-the-shelf tablet is not IEC 6060-1-1 certified but complies with EN 60950. Additionally, its rechargeable batteries are not compliant with IEC 62133. The testing lab claims that since the tablet is outside the patient environment, it is enough it complies with EN 60950 and there is no need to test it according to the IEC 60601-1. They also claim that its power supply does not have to be medical grade power supply, and that no EMC testing according to IEC 60601-1-2 needs to  be performed, as the tablet complies with EN 55032:2012 class B, which is stricter than IEC 60601-1-2. 
I have looked at 510k clearances of similar systems, that include a computer with installed software, intended to be used for navigation in the OR. All of these systems comply with IEC 60601-1 and IEC 60601-1-2.
Does anyone have experience with certifying part of the medical equipment as non-medical equipment?

​Patient environment as defined in IEC 60601-1 3rd edition as 1.5m around the patient.  Any device within that environment must meet medical device requirements.  EN 60950 is not adequate.

------------------------------
Al Van Houdt RAC
Sr. Mgr. Regulatory Affairs & Compliance
Snoqualmie WA
United States
------------------------------

Original Message:
Sent: 23-Jun-2019 11:42
From: Anonymous Member
Subject: Need to comply with IEC 60601-1- and IEC 60601-1-2

This message was posted by a user wishing to remain anonymous

Hi,

We have a system that is cleared for navigation in the OR.  The system contains software that can be installed on a computer with pre-defined minimal requirements.
The company is seeking to make a change and provide the user with an off the shelf tablet as an optional accessory, on which the software will be installed. The user will not be in direct contact with the tablet and the patient at the same time. The tablet may be placed within 0.5m from the patient's bed.
The  off-the-shelf tablet is not IEC 6060-1-1 certified but complies with EN 60950. Additionally, its rechargeable batteries are not compliant with IEC 62133. The testing lab claims that since the tablet is outside the patient environment, it is enough it complies with EN 60950 and there is no need to test it according to the IEC 60601-1. They also claim that its power supply does not have to be medical grade power supply, and that no EMC testing according to IEC 60601-1-2 needs to  be performed, as the tablet complies with EN 55032:2012 class B, which is stricter than IEC 60601-1-2.
I have looked at 510k clearances of similar systems, that include a computer with installed software, intended to be used for navigation in the OR. All of these systems comply with IEC 60601-1 and IEC 60601-1-2.
Does anyone have experience with certifying part of the medical equipment as non-medical equipment?

Yes, we do have experience with IEC 60601 based systems requirements.  I have been dealing with IEC 60601 series of standards for over 25 years.  Please feel free to contact me (see signature line) offline to discuss this issue.

------------------------------
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: 23-Jun-2019 11:42
From: Anonymous Member
Subject: Need to comply with IEC 60601-1- and IEC 60601-1-2

This message was posted by a user wishing to remain anonymous

Hi,

We have a system that is cleared for navigation in the OR.  The system contains software that can be installed on a computer with pre-defined minimal requirements.
The company is seeking to make a change and provide the user with an off the shelf tablet as an optional accessory, on which the software will be installed. The user will not be in direct contact with the tablet and the patient at the same time. The tablet may be placed within 0.5m from the patient's bed.
The  off-the-shelf tablet is not IEC 6060-1-1 certified but complies with EN 60950. Additionally, its rechargeable batteries are not compliant with IEC 62133. The testing lab claims that since the tablet is outside the patient environment, it is enough it complies with EN 60950 and there is no need to test it according to the IEC 60601-1. They also claim that its power supply does not have to be medical grade power supply, and that no EMC testing according to IEC 60601-1-2 needs to  be performed, as the tablet complies with EN 55032:2012 class B, which is stricter than IEC 60601-1-2.
I have looked at 510k clearances of similar systems, that include a computer with installed software, intended to be used for navigation in the OR. All of these systems comply with IEC 60601-1 and IEC 60601-1-2.
Does anyone have experience with certifying part of the medical equipment as non-medical equipment?

But there is more than just IEC 60601-1 that will apply because of wireless issues.

------------------------------
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-Jun-2019 13:37
From: Leonard Eisner
Subject: Need to comply with IEC 60601-1- and IEC 60601-1-2

Yes, we do have experience with IEC 60601 based systems requirements.  I have been dealing with IEC 60601 series of standards for over 25 years.  Please feel free to contact me (see signature line) offline to discuss this issue.

------------------------------
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: 23-Jun-2019 11:42
From: Anonymous Member
Subject: Need to comply with IEC 60601-1- and IEC 60601-1-2

This message was posted by a user wishing to remain anonymous

Hi,

We have a system that is cleared for navigation in the OR.  The system contains software that can be installed on a computer with pre-defined minimal requirements.
The company is seeking to make a change and provide the user with an off the shelf tablet as an optional accessory, on which the software will be installed. The user will not be in direct contact with the tablet and the patient at the same time. The tablet may be placed within 0.5m from the patient's bed.
The  off-the-shelf tablet is not IEC 6060-1-1 certified but complies with EN 60950. Additionally, its rechargeable batteries are not compliant with IEC 62133. The testing lab claims that since the tablet is outside the patient environment, it is enough it complies with EN 60950 and there is no need to test it according to the IEC 60601-1. They also claim that its power supply does not have to be medical grade power supply, and that no EMC testing according to IEC 60601-1-2 needs to  be performed, as the tablet complies with EN 55032:2012 class B, which is stricter than IEC 60601-1-2.
I have looked at 510k clearances of similar systems, that include a computer with installed software, intended to be used for navigation in the OR. All of these systems comply with IEC 60601-1 and IEC 60601-1-2.
Does anyone have experience with certifying part of the medical equipment as non-medical equipment?