Professional Documents
Culture Documents
Specific safety evaluation programs follow International Organization for Standardization (ISO) 10993 standards
and Food and Drug Administration (FDA) guidance (May 1, 1995). The table is based on ISO 10993-1 Evaluation and
Irritation/Intracutaneous
Hemocompatibility
C = Permanent (>30 Days)
Chronic Toxicity
Carcinogenicity
Sensitization
Genotoxicity
Implantation
Cytotoxicity
Notes:
Medical Device
Development 1 2 3 4 5
Process & The
MRO® Approach
CONCEPT & DESIGN VALIDATION & MARKET
CLINICAL POST-MARKET
FEASIBILITY PRECLINICAL TESTING APPROVAL