Auditory alarm standard IEC 60601-1-8

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yumeka

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Dear all,

I am a newbie in design for medical regulation, and would like to know if it is truly required for the rise time of the audio to be 10% - 20% of td. I do not have the actual standard document but notice in another document that in practice the rise time should not be less than 10 ms to prevent mechanical speaker noise.

1. What about rise time is truly required?

2. Honestly I do not know how to make sounds that meet the requirement..... Would it be okay for the FDA is the sound rise time does not meet requirement?

Thanks,
Yumeka
 
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