Haemocompatibility tests needed for Peritoneal dialysis machine?

C

ctct61t

#1
Our Peritoneal dialysis machine, is not directly in contact with blood, but in case patient Peritoneal membrane hurt and bleeding, the machine may be in contact with blood. I'm not sure whether haemocompatibility tests is applied to Peritoneal dialysis machine. Thanks...
 
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Ajit Basrur

Staff member
Admin
#2
ctct61t,

I have moved your question to this section that addresses all Medical Device related standards and am hopeful that you would get good responses.

Did you take a look at Biocompatability standard, ISO 10993-4 ?
 
M

MIREGMGR

#3
If the US is a primary market for you, perhaps you could call up FDA DSMICA and ask them to put you in touch with the 510(k) folks who would handle that equipment type.

If Europe is a primary market, your NB should be able to find out for you, if they don't already know.

My take would be that it's a good idea even if it's not absolutely required.
 
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