Medical Devices QC Testing Procedure - Flexible Medical Solution Bags

[kbng82]

hi,

i'd like to know if there's any website or good sourse of information to know about QC procedure or testing method conducted on medical devices, e.g. flexible medical solution bags, blood bags, etc....

thanks.

 

[Gert Sorensen]

Could you be a little more specific. What do you wish to test for?

 

[kbng82]

we wish to test the welding quality of the IV bags and blood bags, but i'd like to know what else QC test can we carry out on the production of this 2 products, perhaps drop test, bar code test, which i am not so sure which is important, which is not, and perhaps there're many other tests not to my knowledge which is important...

wish some expertise in this field can give me some guidance.. thanks

 

[Gert Sorensen]

I think you would do well by looking at this, that's money well spent!

EN ISO3826-1:2004
Plastics collapsible containers for human blood and blood components
- Part 1: Conventional containers

The requirements for blood bags are rather high, and the equipment you need to test it is a bit specialized, so start by reading the standard. Perhaps, I can give you a little more feedback then

 

[kbng82]

thanks for your suggestion. i will buy this standard to read first. is EN ISO 3826:2004 equivalent to ISO 3826:2003?

in the mean time while i order this standard, any opinion or suggestions from all expertise are most welcomed.

thanks first.

 

[Gert Sorensen]

thanks for your suggestion. i will buy this standard to read first. is EN ISO 3826:2004 equivalent to ISO 3826:2003?

in the mean time while i order this standard, any opinion or suggestions from all expertise are most welcomed.

thanks first.

As far as I can see it should be the same. The 2004 version is the localized version in Denmark. Perhaps you should consider aquiring 3826-2 and 3826-3 as well.

As for suggestions of the top of my head? I would seriously contemplate measuring the hight of the welding. You should aim for a total height of the welding equal to 60-70% of the combined height of the foils.