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HOME
ABOUT US
MEDICAL DEVICE
FOOD & SUPPLY
COSMETICS
TOY
BLOG
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
*