List of Potential Hazards Definitions in Annex E of BS EN ISO 14971:2009

C

CompEng

Hi all,

I have searched the internet but have failed to find definitions for the following example hazards given in Annex E of BS EN ISO 14971:2009.

Use Error.
· Attentional failure
· Memory failure
· Rule-based failure
· Knowledge-based failure
· Routine violation

If anyone can help me out I would be most grateful!

Cheers


Tom
 

sagai

Quite Involved in Discussions
Hi!
:) good question ! :)
For use hazards I propose to review IEC62366 / IEC 60601-1-6.
Regards
Szabolcs
 

Pads38

Moderator
I don't think that those terms are "defined terms" so will not have official definitions.

Use error is defined (62366 definition 3.21)
"act or omission of an act that results in a different medical device response than intended by the manufacturer or expected by the user.
Note: Use error includes slips, lapses and mistakes."

The informative annexs B and C to 62366 have useful discussion on different types of use error.
 

yodon

Leader
Super Moderator
As Pads says, those are not defined or standard terms. They are only "thought stimulators" to get you thinking of how user / use errors could be introduced. You're neither required to address each of these nor restricted to just these.
 
Top Bottom