Biomedical Device Material Justification Form
Project/Device Name
Device ID / Reference No.
Applicant Name
Date
Material Name / Type
Material Grade / Specification
Material Manufacturer / Supplier
Location in Device
Function in Device
Type of Tissue/Fluid Contact
Contacting
Non-Contacting
Duration of Contact
Transient (<1 min)
Short Term (1-30 days)
Long Term (>30 days)
Material Justification
Relevant Standards / Biocompatibility Certificates
Additional Notes