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[Mazid1989]

Are ISO 13485 certified devices compatible as food contact materials?

[Evans X.]

Greetings Mazid,

 

Although I would recommend searching your country's legislation further, I have to say no, they can't be compatible as food contact materials, even though the strictness is there.

The applicability of the medical devices doesn't match those for food contact. Food contact material needs to be tested in a few different food scenarios (acidic, oily, high or low temperature endurance, material migration etc) to be certified as food contact. I guess the medical devices have different parameters, since they are made for contact with human internal or external "surfaces".

 

Regards!