IEC 60601 3rd Edition – Alarms
Alarms, IEC 60601-1 3rd Edition, Regulatory, Standards
This Device Tip will focus on another key aspect of IEC 60601-1 3rd edition, Alarms. In actuality, the requirements for Alarms are actually more defined in the Collateral Standard IEC 60601-1-8,
“General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems”.
One key thing to know right off the bat is that the term ‘Alarm’ in not defined in IEC 60601-1:2012 (Ed. 3.1) or IEC 60601-1-8.
However, there are several other terms defined in IEC 60601-1-8 that include the word ‘Alarm’, the key one of which for this Device Tip is ‘Alarm Condition’:
“state of the Alarm System when it has determined that a potential or actual Hazardous Situation exists for which Operator awareness or response is required”.
A Hazardous Situation is defined as:
“circumstance in which people, property, or the environment are exposed to one or more potential source(s) of physical injury or damage to the health of people, or damage to property or the environment”
So here’s the tip:
Evaluate your device to determine whether any Alarm Conditions can exist during operation, transport or storage.
I have found several situations where a company had a Medical Device and their documentation discussed various ‘alarms’ the device would generate.
However, on careful examination, the devices actually did not determine that a potential or actual Hazardous Situation exists for which Operator awareness or response was required. Thus, the devices had no Alarm Conditions, and thus had no Alarm System, and thus IEC 60601-1-8 did not apply.
More Info
A few key terms:
- Alarm System = parts of Medical Electrical (ME) Equipment or a Medical Electrical System that detect Alarm Conditions and, as appropriate, generate Alarm Signals.
- Hazardous Situation = circumstance in which people, property, or the environment are exposed to one or more hazard(s)
- Hazard = potential source of harm
- Harm = physical injury or damage to the health of people, or damage to property or the environment
- Alarm Signal = type of signal generated by the Alarm System to indicate the presence (or occurrence) of an Alarm Condition.
- Alarm Condition = state of the Alarm System when it has determined that a potential or actual Hazardous Situation exists for which Operator awareness or response is required.
- Derived definitions:
- Hazard = potential source of physical injury or damage to the health of people, or damage to property or the environment
- Hazardous Situation = circumstance in which people, property, or the environment are exposed to one or more potential source of physical injury or damage to the health of people, or damage to property or the environment.
So the key questions to ask are:
Does the ME Equipment determine that a potential or actual Hazardous Situation exists?
- If NO, the ME Equipment has no Alarms
- If YES, the ME Equipment might have Alarms
For the potential or actual Hazardous Situation(s) that the ME Equipment determines exists, is Operator awareness or response is required?
- If NO, the ME Equipment has no Alarms
- If YES, the ME Equipment has Alarms
The truth is, a large percentage of ME Equipment is used on Patients for which there is already a potential source of physical injury or damage to their health. I don’t think the Standard considers this in and of itself to be an Alarm Condition.
Alarm conditions are those situations where the ME Equipment is not able to perform its intended function in a way which would be a potential new source of physical injury or damage to the Patient’s health.
For instance, an Infusion Pump is intended to deliver a controlled volume of fluid at a controlled rate to the Patient. If it cannot reliably deliver a controlled volume of fluid at a controlled rate to the Patient, that would be an Alarm Condition. Common examples would be:
- Fluid line occlusion upstream of the pump that prevents fluid flow
- No fluid upstream of the pump that prevents fluid delivery
- Fluid line occlusion downstream of the pump that prevents fluid flow
- Air in the fluid line
- No electrical power to run the pump
These are Alarm Conditions for which Operator awareness or response is required.