Certifying a PDA as a medical device - (FDA/CE) - For use in the operating room

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valentin

#2
Certifying a PDA as a medical device

Hi,

For a small company it is attractive to use a Personal Digital Assistant (PDA) for the processing and presentation of data in a medical device.

Does anyone have experience with whether a PDA can be certified (FDA/CE)for use in the operating room ? In particular I am worried about leakage current ?

Best wishes

Valentin
 

Al Rosen

Staff member
Super Moderator
#3
valentin said:
Hi,

For a small company it is attractive to use a Personal Digital Assistant (PDA) for the processing and presentation of data in a medical device.

Does anyone have experience with whether a PDA can be certified (FDA/CE)for use in the operating room ? In particular I am worried about leakage current ?

Best wishes

Valentin
I haven't had any experience with approving or certifying a PDA. I think that EMI or arcing in an oxygen environment would be additional concerns. In general meeting ISO 60601-1 and 60601-1-4 would be required. Maybe someone else can comment on this.
 
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