REQUEST FOR PROPOSAL - BIOCOMPATIBILITY TESTING

Please provide the specific information required below in order to get a complete service proposal for medical device biocompatibility testing. Remember to fill out a new form for each device you intend to test.

MANUFACTURER INFORMATION

Legal Manufacturer / OEM / OBL Name *:

Street *:

City / Pincode *:

Country *:

SERVICE REQUEST

SERVICE INTRESTED :

MEDICAL DEVICE INFORMATION

Name of the Medical Device *:

Device Class * :

Packaging * :

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 * :

Storage Temperature * :

Human Body Contact Category * :

Human Body Contact Duration * :

Human Body Contact Area * :

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

SUBMITTER INFORMATION

Contact Person * :

Job Title * :

Contact Number *:

Contact Email *: