Usage of web articles in DHF (Design History File)

renenatasha

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#11
Somashekar,
I don't think that a general literature article will be enough to support a design requirement. Also, the requirement does not provide a clear metric that allows you to compare it directly with the design output. I see a couple of options:
1) Revise your Design Input to eliminate the requirement. This should be the simplest and most straightforward.
2) In your design output document state that it is a bad requirement, is not relevant to the safety or efficacy of the device and, therefore, will not be addressed as a design output.
3) You should be able to go to your sterilization service and get a copy of a permit or letter stating that they comply with environmental regulations with regard to EO emissions. You may also be able to find out the level of emissions from your plant or the processing of one of your loads. The EPA has emissions requirements and so do many local regulatory bodies. You can use compliance to environmental regulations to support your conclusion.
Thanks for your feedback, BLSSETO.

1) I can't remove the sterilization method in the Design Input but I might have to work out a way when it comes to sterilization method vs environmental impact.

2) BTW, if that point is removed from the Design Input, then there's no need to address it in the Design Output :)

3) Love the 3rd point which I've in mind too.

Thanks again. - Rene
 
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