Hello everyone,
Our supplier declare our cardboard in carton can contains latex (CAS 25085-39-6 and CAS 9003-55-8 - SBR latex).
The cardboard is in contact with our implant device. Is it sufficient if we prove that no leachable is on the device and can't come into contact with the patient?
We perfomed all chemical analysis on the product (GC-MS, UPLC/MS, ICP/MS)
Thanks in advance
Elodie
Our supplier declare our cardboard in carton can contains latex (CAS 25085-39-6 and CAS 9003-55-8 - SBR latex).
The cardboard is in contact with our implant device. Is it sufficient if we prove that no leachable is on the device and can't come into contact with the patient?
We perfomed all chemical analysis on the product (GC-MS, UPLC/MS, ICP/MS)
Thanks in advance
Elodie
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