IEC 60601-1-8 - When does an error message become an alarm signal?

N

NASAN Medical

#11
dear Shimon,
it will surly help me out..........
i guess if in-house test reports is acceptable to Notified Body then no issues.
but if you do testing in-house testing facility then how would you eliminate sound around your test equipment?
do we actually measure in dB level or just waveform is sufficient? plus, how would you validate it with out TRF?
hope you get my point..

thank you.
 
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shimonv

Trusted Information Resource
#12
dear Shimon,
it will surly help me out..........
i guess if in-house test reports is acceptable to Notified Body then no issues.
but if you do testing in-house testing facility then how would you eliminate sound around your test equipment?
do we actually measure in dB level or just waveform is sufficient? plus, how would you validate it with out TRF?
hope you get my point..

thank you.
I advise you to do an external test. It will probably be quicker and cost effective in comparison to you investing the time to write a protocol and test report. After the first external test you might be in a better position to do it in-house.

Shimon
 
N

NASAN Medical

#13
dear Shimon,
thanks alot. that's true, its time consuming and hard to follow protocol and TRF requirements.
i will discuss your view with my team-mates.
thanx again......
thanx elsmar forum.....
 

Peter Selvey

Staff member
Super Moderator
#14
Just an interesting side note to the original discussion - when the standard was first published, there was no actual definition of an "alarm". Instead the key terms "alarm condition", "alarm signal" and "alarm system" just referred to each other (circular references) without ever establishing exactly what an "alarm" is.

The latest edition/amendment still has not fixed this and the circular references remain. Clause 4 provides a de-facto definition which indicates an alarm is something that notifies the operator as a risk control. Structurally that is wrong, you should be able to determine if a standard is applicable purely from the scope and definitions. The history and wrong structure might be part of the reason the standard gets overlooked.

In the case of notifications, error messages, they could be a risk control but the requirements in the standard are fairly light, for example being legible from the position of the operator. In my opinion, they could be easily incorporated in IEC 60601-1, leaving IEC 60601-1-8 free to focus on "real" alarms that need reasonable prompt attention. Otherwise, you end up spending time and effort making a big IEC 60601-1-8 report that is 98% not applicable.

:2cents:
 
#15
So, how do we reconcile with the terminology of warning indications and alarm indications as per 60601-1 3.2 ed. Both are used for risk mitigation, but are called out as differently.
Also, for technical alarms such as power fail, 60601-1-8 provides exemption for not meeting audio characteristic. Does this mean that we need to visual/ flashing requirements even in this case? Let me know your thoughts
 
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