BIOCOMPATIBILITY TESTING

1. MANUFACTURER INFORMATION
Legal Manufacturer / OEM / OBL Name*
Street*
City /Pincode*
Country*
Website Address
2. SERVICE REQUEST
SERVICE INTRESTED	Select Biocompatablity Testing Biological Evaluation Biological Evaluation + Biocompatablity Testing
3. MEDICAL DEVICE DESCRIPTION
Name of the Medical Device*
Device Class*	Select EU Class I EU Class Is EU Class Im EU Class Ir EU Class II EU Class III FDA Class I FDA Class II FDA Class III Don't Know
Packaging*	Select Sterile Non Sterile
Dimensions of device (Please fill as appropriate)	Length (cm) Diameter (cm) Breadth (cm) Thickness (mm) Height (cm) Volume (ml)
Intended Use
Device Description*
Total surface area of test item (cm2)
Weight of device (g)
Temperature Stability*	Select 121 ℃ 70 ℃ 50 ℃ 37 ℃
Storage Temperature*	Select Room Temperature (20 to 30 ℃) Refrigerator (2 to 8 ℃) Freezer (< 0 ℃)
Human Body Contact Category*	Select A - Surface Devices B - External Communicating Devices C - Implant Devices
Human Body Contact Duration*	Select A - Limited (< 24h) B - Prolonged (24h to 30 days) C - Long Term (> 30 days)
Human Body Contact Area*	Select Intact Skin Mucosal Membrane Breached or Compromised Surface
Test to be conducted [ Select Test Code from Below Table ]*
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
Contact Person* Select Mr Mrs Dr Prof Ms
Job Title*
Contact Number*
Contact Email*