IFU for combined OTC Medical Device in light of IEC 60601-1-11

S

SmallD

#1
Hopefully a simple question:
If you have an OTC medical device (part of which is NOT medical, i.e., medical added to a common non-medical) and the IFU needs to be compliant to 60601-1-11 (of course also to 60601-1 3rd edition) then could all the warnings/cautions necessary be added to an appendix at the end of the IFU (as opposed to placing in the beginning and within the text)?
This is a medical device which is OTC and depends (marketing wise) on a presentable IFU; I have not found any specific guidelines covering this.
Anybody have any thoughts on this?:confused:
 
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Marcelo

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#2
Re: IFU for combined OTC medical device in light of 60601-1-11

Hopefully a simple question:
If you have an OTC medical device (part of which is NOT medical, i.e., medical added to a common non-medical) and the IFU needs to be compliant to 60601-1-11 (of course also to 60601-1 3rd edition) then could all the warnings/cautions necessary be added to an appendix at the end of the IFU (as opposed to placing in the beginning and within the text)?
This is a medical device which is OTC and depends (marketing wise) on a presentable IFU; I have not found any specific guidelines covering this.
Anybody have any thoughts on this?
In principle, you can put the information in the IFU where you want. Standards are usually worried with requerements, not sulutions to requirements. The place of things in the manual is a solution, not a requirement, so standards would generally not define them - it's up to the manufacturer.

However, one imporrtant aspect - in in the case of a homecare equipment it's even more important- what really should define how your IFU and other interface aspects are created is the usability engineering process. The usability process will validate that your IFU is usable and understandable by the user, and for exmple if it's structured in a way to enable safe use.

Please remember that the safety information providade in IFUs is the third option of risk control measures of the risk management process per ISO 14971. It's the least preferred way, ans this is so because in this case, safety is too dependent on the user. IN the case of a lay user, it's even worse, so there's a need to carefully create an IFU which will enable that the equipment use is safe.

For some more info on this, please refer to an interestingguidance document from the FDA - Write It Right. Recommendations for Developing. User Instruction Manuals for Medical Devices Used in Home Health Care.
 
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