Hi all,
We are developing a wearable device that measures single vital sign.
It is basically a small box with sensors that the patient wear.
The device communicates with a tablet via low energy Bluetooth (BLE).
Inside the tablet we have our app that is used to present the measured data and log it.
The device intended environment is hospitals and is intended to the European market and therefore will be evaluated by a notified body.
The wearable device is considered a medical device and shall comply with IEC 60601-1, IEC 60601-1-2.
The SW/app for presenting and logging the data is also considered a medical device and shall comply to IEC 62304 and the relevant clauses in IEC 60601.
However, we would like to include a commercial tablet (e.g. Samsung) with our system on which our app would be installed. This tablet does not comply with IEC 60601, but with IEC 60950 (TLE).
As part of our risk management we decide to replace the tablets' charger with an IEC 60601 approved charger and define that the tablet will be placed outside (>1.6m) from the patient environment
Does anyone familiar with a similar situation?
Should I expect any issues with the notified body?
How should we address/define the tablet during the IEC 60601 tests? it is not rea
Hope to be able to use your experience.
Thanks in advance.
We are developing a wearable device that measures single vital sign.
It is basically a small box with sensors that the patient wear.
The device communicates with a tablet via low energy Bluetooth (BLE).
Inside the tablet we have our app that is used to present the measured data and log it.
The device intended environment is hospitals and is intended to the European market and therefore will be evaluated by a notified body.
The wearable device is considered a medical device and shall comply with IEC 60601-1, IEC 60601-1-2.
The SW/app for presenting and logging the data is also considered a medical device and shall comply to IEC 62304 and the relevant clauses in IEC 60601.
However, we would like to include a commercial tablet (e.g. Samsung) with our system on which our app would be installed. This tablet does not comply with IEC 60601, but with IEC 60950 (TLE).
As part of our risk management we decide to replace the tablets' charger with an IEC 60601 approved charger and define that the tablet will be placed outside (>1.6m) from the patient environment
Does anyone familiar with a similar situation?
Should I expect any issues with the notified body?
How should we address/define the tablet during the IEC 60601 tests? it is not rea
Hope to be able to use your experience.
Thanks in advance.