Ted Ekert said:

<If a ground connection fails, there will be no indication of a problem to
the user.  The product will likely continue to operate perfectly normally.
A second failure, such as a loose line wire, could lead to the sudden and
unexpected energizing of exposed metal.  The product has now become
hazardous without warning.>

This makes sense of course, but (going off track a little bit) this implies
that the equipment has TWO faults, and the premise at the moment seems to
be  'Safety under SINGLE FAULT conditions'.

I guess I'm asking for opinions, in view of the latest standards leaning or
Risk Analysis etc., (e.g. IEC 60601-1 Rev 3) is..  "How many stacked risks
should we take into account?" when defining 'Risk'.

I mean, it's perfectly feasible to lose a ground connection on a case (1
fault), and for a live wire to come loose and touch the case (2 fault).  Do
we have to take ALL scenario's like that into account?  In other words,
ensure the design is safe under double, or even triple fault conditions?

I'm reminded of a mains plug on a piece of UK equipment, where the lead was
tugged, the Earth wire pulled out and ended up on the Live wire.   Of
course the whole case became live.This was found because a secretary felt a
'tingle' when she touched the case.  I guess her plastic high heels saved
her that time.  One event, but two faults.

So how many levels of fault should we take into account in order to fulfil
the Risk Analysis requirements?

Regards,

Chris.

Chris Duprés
Compliance Engineer
Elekta Limited
Linac House
Fleming Way
Crawley
West Sussex
RH10 9RR

www.elekta.com
tel:  +44 (0) 1293 654311
fax:  +44 (0) 1293 654260


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