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IEC 60601-2-30 - Is it mandatory to claim alarms?

sreibs

Starting to get Involved
#1
Hi,

We are designing a device with blood pressure measure (like any home blood pressure monitor). 60601-2-30 says that device shall provide physiological alarms with auditory and visual means.

In our case, their is no point to have an alarm because the device is used with a practitioner which monitor the data in real time. On top of that, most of the home blood pressure does not have "auditory" alarm.

Can we justify there is no need for alarm because of our intended use ?

Thank you in advance for your reply.

Best regards
 
Elsmar Forum Sponsor

Peter Selvey

Staff member
Moderator
#2
Check the standard more carefully. In all related places, it says "if" the alarm is provided, do XYZ, nowhere says the alarm "shall" be provided. This is for physiological alarms; there are some other alarms that may be required for technical conditions.
 
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