Standards for defining audible alarms/warnings for OR instruments

ThasYuwa

Inactive Registered Visitor
#1
Hello everyone,
I have read through most of 60601-1-8 to understand its context. I would like to know if there is a mandatory standard (in the context of US and Canada) that prescribe specific requirements for constructing audible alarms for use in devices in the Operating Room?
From what I have observed in the OR, every instrument appears to have its own design paradigm to arrive at audible alarms and warning signals. Is it is really open ended?
I am aware of the fact that there is a certain sound level (SPL) based on exposure limits published OSHA. I am not after this standard as this describes the upper bound and it does not provide guidance on how to construct attention grabbing alarms.
Any and all pointers are much appreciated.
Cheers
Thas
 
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Pads38

Trusted Information Resource
#2
You do not mention the type of equipment you are considering, but there are specific standards for some types of equipment that might have specific alarm requirements (for instance - IEC 60601-2-49 Multi-function patient monitoring equipment).

However, if you are considering alarms and alarm management in a more general way you might find some useful information here:-

https://www.ecri.org/Forms/Pages/Alarm_Safety_Resource.aspx

ECRI is an independent, not-for-profit organisation who analyse safety trends and effectiveness of medical equipment. They publish "Top Ten" lists of hazards and alarms always come close to the top, generally due to alarm overload and fatigue.

Disclosure - no connection
 

Peter Selvey

Staff member
Moderator
#3
At the back of IEC 60601-1-8 there is an Annex F which is intended to try and harmonize some of the melodies used for alarm sounds. It is not mandatory, but if the melodies are used they should match the meaning in the Annex.
 

ThasYuwa

Inactive Registered Visitor
#4
Thank you both for the valuable pointers. The device I am considering is not a life support device. However it is a surgical device that is electrically actuated.
I shall read through your references and get back with additional clarifications.
Cheers
 
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