External Label Content of multi-device (sterile and nonsterile)

belemsanchez

Involved In Discussions
#1
:bigwave:

Please, I’d like to consult about external label of multi-device kits containing a combination of sterile and nonsterile products, I’m not sure if the external label must be labelled with sterile symbol or not.
I’d be very grateful if you can help me about this doubt.
 
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pkost

Trusted Information Resource
#2
I would avoid indicating that the pack itself is completely sterile, which you are risk of doing if you place the sterile symbol somewhere on the label

It is quite common to see the label have a list of items in the pack with the CE mark (and variable notified body number) next to each...You could do this with the sterile symbol to indicate sterility
 

rangani_rj

Involved In Discussions
#3
From FDA's guidance document for convenience kit,

"The labeling for these kits tends to be rather basic, identifying the assembler or manufacturer of the particular kit and the intended use(s). Additional processing typically involves affixing the label to the outside packaging of the kit and terminal sterilization of the kit and its components."


In convenience kits/tray, sterile components are packaged individually after sterilization (or packaged and then sterilized, if its Gamma sterilized) which are then assembled with non sterile components in kit. in such cases label of individual components generally indicates sterility status. We don't need to put sterile symbol on kit.

We can put sterility symbol or terminal sterilization process to kit if it is applicable to kit as a whole.
 
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