Acoustic Noise of a Medical Equipment

S

S_L_N

#1
Howdy All,

Looking for some standard which can give us a lead to chk our product against the required limits. Our product will be used either inside the OT or outside in a server room.

IEC 60601 specifies only with respect to alarms used in a medical device.

Any lead on this front will be appreciated.

Thanks.

S_L_N
 
Elsmar Forum Sponsor
S

SteveK

#2
Hi S_L_N,

I can only quote from the following:

BS EN 60601-1:2006
9.6.2.1 Audible acoustic energy
In normal use, the patient, operator and other persons shall not be exposed to acoustic energy from ME equipment, except sound from auditory alarm signals, exceeding the levels specified below:
-80 dBA for a cumulative exposure of 24 h over a 24 h period; an offset of 3 dBA is to be added to this value when halving the cumulative time over a 24 h period (e.g. 83 dBA for 12 h over a 24 h period).
-140 dB un-weighted sound pressure level for impulsive or impact acoustic energy (noise).

I assume the 140 dB part means alarms (as you indicate) and the 80 dBA is what you require i.e. the norm as indicated above.

Hope this helps.:)

Steve
 

Tim Folkerts

Super Moderator
#3
I would assume that the 140 dB is for a sudden, short sound ("impulsive or impact acoustic energy") like a "clap" or pop".

A 140 dB alarm would be literally "deafening"!

Some typical values ...

  • 110 dB Front row rock concert
  • 120 dB Threshold of pain
  • 140 db Jet taking off

Another source lists a gunshot at close range as 140 dB. A single, brief exposure to this shouldn't be TOO damaging, but a continuous sound of this level would be painful AND damaging!


Tim F
 
M

MIREGMGR

#4
The 60601 language, as I read it, is intended to apply to all device-generated acoustical energy except alarm sounds.
 
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