R
Hello,
I am looking for some guidance on the Applied Part classification of the measurement sensors used with our system. The application area is cardiac bypass and ECMO; our system consists of a monitor and measurement sensors which are clipped onto the PVC tubes carrying the patient's blood. There is also a temperature sensor which is inserted into a dedicated port in the bypass equipment.
The monitor and sensors are supplied by us, all other parts of the system are supplied by third parties and are outside our control.
The system is classed as a multifunction patient monitor so the particular standard 60601-2-49 applies.
The approach I have used so far is that none of the measurement sensors directly contact the patient's skin, so the decision to classify any of the sensors as Applied Parts is driven by the risk management process clause 4.6.
The temperature sensor is a thermistor enclosed in a stainless steel jacket. The sensor is supplied by a third party, so the class of insulation between the sensing element and the jacket (which contacts the blood) is unknown and must be assumed to be Basic only. Therefore this should be classified as Applied Part type BF and provided with isolation from the rest of the system.
All of the other sensors are plastic with no accessible conducting parts, and no path for fluid ingress (the measurements are performed optically or ultrasonically). I would argue that these should not be classified as Applied Parts at all. However I have seen at least one very similar product from another manufacturer where the ultrasonic sensor head is classed as type BF.
Another complication is that 60601-2-49 requires all type BF applied parts to be defibrillation proof. I can see why this is needed for ECG electrodes etc, but does this requirement extend to applied parts that have been classified as such through the clause 4.6 route?
Thanks in advance for any clarification on these issues.
R.
I am looking for some guidance on the Applied Part classification of the measurement sensors used with our system. The application area is cardiac bypass and ECMO; our system consists of a monitor and measurement sensors which are clipped onto the PVC tubes carrying the patient's blood. There is also a temperature sensor which is inserted into a dedicated port in the bypass equipment.
The monitor and sensors are supplied by us, all other parts of the system are supplied by third parties and are outside our control.
The system is classed as a multifunction patient monitor so the particular standard 60601-2-49 applies.
The approach I have used so far is that none of the measurement sensors directly contact the patient's skin, so the decision to classify any of the sensors as Applied Parts is driven by the risk management process clause 4.6.
The temperature sensor is a thermistor enclosed in a stainless steel jacket. The sensor is supplied by a third party, so the class of insulation between the sensing element and the jacket (which contacts the blood) is unknown and must be assumed to be Basic only. Therefore this should be classified as Applied Part type BF and provided with isolation from the rest of the system.
All of the other sensors are plastic with no accessible conducting parts, and no path for fluid ingress (the measurements are performed optically or ultrasonically). I would argue that these should not be classified as Applied Parts at all. However I have seen at least one very similar product from another manufacturer where the ultrasonic sensor head is classed as type BF.
Another complication is that 60601-2-49 requires all type BF applied parts to be defibrillation proof. I can see why this is needed for ECG electrodes etc, but does this requirement extend to applied parts that have been classified as such through the clause 4.6 route?
Thanks in advance for any clarification on these issues.
R.