New edition of IEC 60601-1 - Risk assessment to determine the liquid - 11.6.3

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celia4237

#1
In the subclause 11.6.3, how to use risk assessment to determin the liquid type, volume, duration and location of the spill.

That is a common problem, how to use risk management to determin test parameter?
 
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Marcelo

Inactive Registered Visitor
#2
Re: Question about new edition of IEC 60601-1

This is, i think THE main problem with using the new series of IEC 60601 standards: how to use standards requirements in conjunction with a risk management framework.

Well, trying not to complicate too much: the requirements of safety standards are risk controls options for manufacturers. So, in in the first place you would have to identify hazardous situations (in my present view, i would derive the hazardous situation from a requirement on a requirements management process or from a further hazard identification process ), estimate risk, define that the risk of the hazardous situation is unnaceptable using your risk acceptability criteria, and then you would need to apply a risk control option. This is where the standard requirement would come in. You have a lot of technical options to control the risk, but the safety standard requirement is the easiest because someone has already though about it. Then you would have to implement the control, and verify the implementation and effectiveness of the control measure. If you did not use the safety standard requirement, you would have to create a "test" to verify both. As you has used the easiest way, things just happen to be a little more easier, because, besides giving a risk control measure option (the requirement itself) the standard also give you the way to verify the implementation and effectiveness (the test method). Only problem is, some test methods parameters can vary, because of different environmental conditions for example...so, you only need to define the right parameters to verify the implementation and effectiveness of your risk control measure option.

All this information, surely, will need to be in your product risk management file.
 
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celia4237

#3
mmantunes, thank you very much. It is really a good response and gives me some useful guide.

It is really interesting for me in the process of learning IEC 60601-1.
 

Tiago Alfenas

Starting to get Involved
#4
Good afternoon, Celia.
I'm new to the 14971 area, I came across this requirement 11.6.3 and I do not know how to treat it.
Could you give me an explanation of how you did it? Thanks for listening
 

Al Rosen

Staff member
Super Moderator
#5
Good afternoon, Celia.
I'm new to the 14971 area, I came across this requirement 11.6.3 and I do not know how to treat it.
Could you give me an explanation of how you did it? Thanks for listening
Tiago, this thread is over 10 years old and celia is no longer active. I would suggest that you start a new thread.
 
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