BIOCOMPATIBILITY TESTING


1. MANUFACTURER INFORMATION

2. SERVICE REQUEST

3. MEDICAL DEVICE DESCRIPTION

Test Code Test Name Test Code Test Name
01BT Cytotoxicity 13BT Hemocompatibility: Partial thromboplastin time - PTT
02BT Sensitization 14BT Hemocompatibility: (Platelets and Leucocytes)
03BT Intra-cutaneous / Irritation 15BT Hemocompatibility: Platelet Activation Test
04BT Material medicated Pyrogenicity 16BT Carcinogenicity
05BT Acute systemic toxicity 17BT Reproductive/developmental toxicity
06BT Subacute toxicity 18BT Biodegradation
07BT Subchronic toxicity 19BT Ethylene oxide sterilization residuals
08BT Implantation Effects 20BT Degradation from polymeric
09BT Hemocompatibility 21BT Degradation from ceramics
10BT Genotoxicity - Bacterial reverse mutation 22BT Degradation of metals and alloys
11BT Genotoxicity - Chromosomal aberration test 23BT Limits for leachable substances
12BT Hemolysis test (Direct & Indirect contact method) 24BT Chemical characterization

4. SUBMITTER INFORMATION