Hello people
The new version of IEC 60601 asks that the manufacturer define the expected service life of the medical device in question. This does not have to be based on engineering calculations, but can be based, for example, on financial factors (also, ISO 13845 asks for a lifetime definition - see more on that on this thread - Lifetime of the Medical Device - What is the most appropriate definition?)
Anyway, i´m trying to figure out how to do that using engineering analysis. I mean, in my opinion it would be a blend of reliability and mantainability analisys paired with financial and liability analysis and other factors; this surely would not be an easy thing to do.
Problem is, i´m having difficult finding literature on this in a system level. The only focused book on this topic, Medical device reliability and associated areas, touch all the areas i mentioned, but separated, not together. I do think that this kind od thing depends on the particular equipment and company. Anyone would have some examples to put some light on the subject?
The new version of IEC 60601 asks that the manufacturer define the expected service life of the medical device in question. This does not have to be based on engineering calculations, but can be based, for example, on financial factors (also, ISO 13845 asks for a lifetime definition - see more on that on this thread - Lifetime of the Medical Device - What is the most appropriate definition?)
Anyway, i´m trying to figure out how to do that using engineering analysis. I mean, in my opinion it would be a blend of reliability and mantainability analisys paired with financial and liability analysis and other factors; this surely would not be an easy thing to do.
Problem is, i´m having difficult finding literature on this in a system level. The only focused book on this topic, Medical device reliability and associated areas, touch all the areas i mentioned, but separated, not together. I do think that this kind od thing depends on the particular equipment and company. Anyone would have some examples to put some light on the subject?