PEMS Hazards - IEC 60601 Clause 14.6 - Internal data use - Pressure sensor

E

Emily Tosio

Registered
#1
#1
Clause 14.6 helpfully lists some hazards to consider related to PEMS including: undesired feedback, unavailable data, lack of integrity of data, incorrect data, etc.
Are these listed hazards relevant to devices that don't provide data to the user?

The device I'm working on does not provide any data to the user but uses data internally (e.g. reading a pressure sensor and controlling a motor based off the reading to reach an ideal pressure). I think for devices that use data only, the hazards would be the resulting issue, such as loss of function. Incorrect data from the pressure sensor would be a foreseeable event potentially leading to the device providing too much or too little performance. Do you agree?
 
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T

Tidge

Quite Involved in Discussions
#2
#2
Emily Tosio said:
Clause 14.6 helpfully lists some hazards to consider related to PEMS including: undesired feedback, unavailable data, lack of integrity of data, incorrect data, etc.
Are these listed hazards relevant to devices that don't provide data to the user?
Click to expand...
If data is 'flowing' between units internal to a system (and not 'presented' to a user/patient), it seems to me that it could be possible (based on the design) for a hazardous situation could arise that is worth analyzing. It will of course depend on the nature of your device's design. It may be possible to expose the need for appropriate risk controls without having to keep digging deeper.

In the case you describe (a pressure sensor participating in the control of a motor): I can imagine that this hypothetical device requires a pressure sensor calibration (a risk control) because of ambient differences in air pressure (sea level vs. mountainous elevations). Presumably such a risk control would derive from "incorrect data" from the pressure sensor.
 
E

Emily Tosio

Registered
#3
#3
Tidge said:
If data is 'flowing' between units internal to a system (and not 'presented' to a user/patient), it seems to me that it could be possible (based on the design) for a hazardous situation could arise that is worth analyzing. It will of course depend on the nature of your device's design. It may be possible to expose the need for appropriate risk controls without having to keep digging deeper.
Click to expand...
Yes I agree that those are hazardous situations that should be analysed. However, I would not call them Hazards. I would say the hazards relevant to those hazardous situations are the device delivering too much or too little pressure. My issue is with the text of 60601-1 clause 14.6 saying that they are hazards. I would only consider them to be hazards if the device was providing the information to the user so the data is a function of the device.
 
B

Benjamin Weber

Trusted Information Resource
#4
#4
You should apply your risk management process: Analyse and evaluate the probability of the line of events that could lead to a hazardous situation, e.g. overpressesure due to wrong sensor output. Then evaluate the severity and probability of the corresponding harm, e.g. serious injury of the patient.

Finally evaluate the risk: Is it acceptable? OK. If not, implement risk control/mitigation measures. This could be regular sensor calibration or maybe redundancy. If depends on your device.

To make a long story short: Your risk evaluation decides, if there is a hazard or not.
 
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