Regrind Material in Medical Devices

#1
Are they any regulatory guidelines and/or specifications for use of regrind material in medical devices? What would be an acceptable percentage for US and EU market
 
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#2
I am not aware of any regulatory requirements for regrind. The only standard that refers to regrind is ISO15378 (Primary packaging materials for medicinal products), which says"8.5.1.3.11 Unless agreed with the customer, thermoplastic materials shall not be reground and reused in primary packaging materials.".

This is one where you need to do your own risk assessment on your product and the plastic involved, then determine what is acceptable to you.
 
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